Asthma
Conditions
Keywords
CAT-354, Tralokinumab, Asthma
Brief summary
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled, moderate-to-severe, persistent asthma.
Detailed description
Study MI-CP199, a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm, multicenter study will evaluate the effect of 3 SC treatment regimens of CAT-354 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.
Interventions
OTHERPlacebo
Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
BIOLOGICALCAT-354 150 mg
CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
BIOLOGICALCAT-354 300 mg
CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
BIOLOGICALCAT-354 600 mg
CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female subjects * Age 18 to 65 years at the time of Screening * Subjects must have a body mass index (BMI) between 18 and 40 kilogram per square meter (kg/m\^2) * Written informed consent obtained from the subject prior to performing any protocol related procedures, including Screening evaluations * Physician-diagnosed moderate-to-severe, persistent asthma requiring treatment with appropriate asthma controller medication * Shows forced expiratory volume in 1 second (FEV1) reversibility postbronchodilator of greater than or equal to (\>=)12 percent and \>=200 milliliter (mL) or have shown such values in a previous test within the last year, or have a positive airway hyperresponsiveness (AHR) test result in the last year * Pre-bronchodilator FEV 1 value \>=40 percent of individual predicted value at Visits 1 and 3 * Uncontrolled asthma consistent with Expert Panel Report (EPR)-3. In the 2 to 4 weeks preceding Screening, subjects should have a history of 1 or more of the following: Daytime asthma symptoms \>=2 days/week, Nighttime awakening \>=1 night/week, Salbutamol use \>=2 days/week * An Asthma control questionnaire (ACQ) score \>=1.5 at Visits 1 and 3 * At least 1 occurrence of asthma exacerbation in the past year that required an unscheduled medical encounter * Men, unless surgically sterile, must likewise practice 2 effective methods of birth control (condom with spermicide) and must use such precautions from Day 1 through Study Day 169 * Otherwise healthy by medical history and physical examination for that age group * A chest x-ray or computed tomography (CT) scan within the previous 12 months with no findings suggestive of acute or chronic respiratory pathology other than asthma * Ability and willingness to complete the follow-up period until Day 169 as required by the protocol.
Exclusion criteria
* Known history of allergy or reaction to any component of the investigational product formulation * Acute illness other than asthma at the start of the study * History of an active infection within 4 weeks prior to Screening, or evidence of clinically significant active infection, including ongoing chronic infection * History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; or a diagnosis of parasitic infection within 6 months prior to Screening * Use of immunosuppressive medication (except oral prednisone up to 10 milligram/day (mg/day) and inhaled and topical corticosteroids) within 30 days before randomization into the study * Receipt of immunoglobulin or blood products within 30 days before randomization into the study * Receipt of any investigational drug therapy or use of any biologicals including omalizumab within 6 months before the first dose of investigational product in this study or within 5 half-lives of an investigational agent or biologic, whichever is longer * History of any known immunodeficiency disorder * A positive hepatitis B surface antigen, or hepatitis C virus antibody * A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report * A live or attenuated vaccination received within 4 weeks prior to Screening * Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the subject in the study * History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator * Lactation (women) * History of treatment for alcohol or drug abuse within the past year * History suggestive of chronic obstructive pulmonary disease (COPD) and of cigarette smoking \>=10 pack-years * Evidence of any systemic disease on physical examination * History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy less than or equal to (\<=)1 year prior to Study Day 1 or other malignancies treated with apparent success with curative therapy \<=5 years prior to entry * Known exposure to inhaled occupational agents or fumes * Any condition (eg, cystic fibrosis \[CF\] or COPD) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results * Individuals who are legally institutionalized * Employees of the clinical study site or any other individuals involved with the conduct of the study, or family members of such individuals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Day 1 and 92 | Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline. |
| Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Day -7 to 1 (predose), Day 2 to 169 | The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169. |
| Number of Puffs of Rescue Beta-2 Agonist Per Week | Day -7 to 169 | Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169. |
| Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Day 1, 29, 57, 92, 127 and 169 | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). |
| Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Day 1, 29, 57, 92, 127 and 169 | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline |
| Patient Global Impression of Change (PGIC) | Day 92 and 169 | Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better). |
| Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | Day 92 and 169 | Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (\<=) 0.75 or mean ACQ score greater than (\>) 0.75 and less than (\<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (\<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (\>) 0.75 but less than (\<) 1.5 indicated partly controlled asthma. |
| Time to First Observed Asthma Control | Day 1 to Day 92 and Day 169 | Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (\>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). |
| Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit | Day 1, 92 and 169 | — |
| Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit | Day 1, 92 and 169 | — |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Day 1 to 169 | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state. |
| Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 92 and 169 | Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission. |
| Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to Day 92 and Day 169 | Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days\*365 days, where X = 92 or 169). |
| Time to First Moderate or Severe Asthma Exacerbation | Day 1 to Day 92 and Day 169 | Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. |
| Serum Concentration for CAT-354 | Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169 | — |
Countries
Bulgaria, Germany, Poland, Romania, United Kingdom
Participant flow
Recruitment details
A total of 357 participants were screened in this study, out of which 194 participants me the eligibility criteria and were enrolled and randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 48 |
| CAT-354 150 mg CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 47 |
| CAT-354 300 mg CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 51 |
| CAT-354 600 mg CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85. | 48 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 1 |
| Overall Study | Other | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | CAT-354 150 mg | CAT-354 300 mg | CAT-354 600 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 47.2 years STANDARD_DEVIATION 9.8 | 43.4 years STANDARD_DEVIATION 11.1 | 48.7 years STANDARD_DEVIATION 11 | 49.8 years STANDARD_DEVIATION 10.4 | 47.3 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 33 Participants | 19 Participants | 36 Participants | 28 Participants | 116 Participants |
| Sex: Female, Male Male | 15 Participants | 28 Participants | 15 Participants | 20 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 47 | 19 / 47 | 25 / 51 | 25 / 48 |
| serious Total, serious adverse events | 3 / 47 | 2 / 47 | 0 / 51 | 1 / 48 |
Outcome results
Primary
Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92
Asthma Control Questionnaire (ACQ) is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Data collected on Day 1 prior to dosing was considered as baseline. Results were reported for overall ACQ score.
Time frame: Day 1 and 92
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued prior to receiving 4 doses due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Day 1 (n=46, 46, 50, 47) | 2.63 units on a scale | Standard Deviation 0.51 |
| Placebo | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Change at Day 92 (n= 46, 46, 51, 47) | -0.61 units on a scale | Standard Deviation 0.9 |
| CAT-354 150 mg | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Change at Day 92 (n= 46, 46, 51, 47) | -0.73 units on a scale | Standard Deviation 1.12 |
| CAT-354 150 mg | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Day 1 (n=46, 46, 50, 47) | 2.72 units on a scale | Standard Deviation 0.58 |
| CAT-354 300 mg | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Day 1 (n=46, 46, 50, 47) | 2.62 units on a scale | Standard Deviation 0.5 |
| CAT-354 300 mg | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Change at Day 92 (n= 46, 46, 51, 47) | -0.70 units on a scale | Standard Deviation 0.93 |
| CAT-354 600 mg | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Day 1 (n=46, 46, 50, 47) | 2.72 units on a scale | Standard Deviation 0.76 |
| CAT-354 600 mg | Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 | Change at Day 92 (n= 46, 46, 51, 47) | -0.86 units on a scale | Standard Deviation 1.09 |
p-value: 0.573ANOVA
p-value: 0.64ANOVA
p-value: 0.224ANOVA
Secondary
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
Time frame: Day 1, 29, 57, 92, 127 and 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 127 (n=41,42,44,42) | 4.64 units on a scale | Standard Deviation 1.2 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 92 (n=40,42,40,38) | 4.68 units on a scale | Standard Deviation 1.19 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 57 (n=44,40,43,45) | 4.61 units on a scale | Standard Deviation 1.02 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 127 (n=41,42,44,42) | 4.18 units on a scale | Standard Deviation 1.58 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 57 (n=44,40,43,45) | 4.57 units on a scale | Standard Deviation 1.03 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 29 (n=43,41,44,40) | 4.47 units on a scale | Standard Deviation 1 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 92 (n=40,42,40,38) | 4.77 units on a scale | Standard Deviation 1.17 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 29 (n=43,41,44,40) | 4.06 units on a scale | Standard Deviation 1.26 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 1 (n=41,41,44,39) | 4.38 units on a scale | Standard Deviation 0.83 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 169 (n=41,44,45,44) | 4.82 units on a scale | Standard Deviation 1.3 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 127 (n=41,42,44,42) | 4.74 units on a scale | Standard Deviation 1.33 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 1 (n=41,41,44,39) | 3.88 units on a scale | Standard Deviation 1.28 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 92 (n=40,42,40,38) | 4.70 units on a scale | Standard Deviation 1.16 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 29 (n=43,41,44,40) | 4.39 units on a scale | Standard Deviation 1.04 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 169 (n=41,44,45,44) | 5.05 units on a scale | Standard Deviation 1.56 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall : Day 1 (n=41,41,44,39) | 4.22 units on a scale | Standard Deviation 0.83 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 127 (n=41,42,44,42) | 4.69 units on a scale | Standard Deviation 1.22 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 169 (n=41,44,45,44) | 4.13 units on a scale | Standard Deviation 1.54 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 127 (n=41,42,44,42) | 5.08 units on a scale | Standard Deviation 1.4 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 92 (n=40,42,40,38) | 5.00 units on a scale | Standard Deviation 1.31 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 169 (n=41,44,45,44) | 4.72 units on a scale | Standard Deviation 1.29 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 92 (n=40,42,40,38) | 4.16 units on a scale | Standard Deviation 1.56 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 57 (n=44,40,43,45) | 4.85 units on a scale | Standard Deviation 1.36 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 29 (n=43,41,44,40) | 4.64 units on a scale | Standard Deviation 1.27 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 1 (n=41,41,44,39) | 4.15 units on a scale | Standard Deviation 0.88 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 57 (n=44,40,43,45) | 4.07 units on a scale | Standard Deviation 1.34 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 1 (n=41,41,44,39) | 4.30 units on a scale | Standard Deviation 1.08 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 169 (n=41,44,45,44) | 4.68 units on a scale | Standard Deviation 1.28 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 29 (n=43,41,44,40) | 4.32 units on a scale | Standard Deviation 1.08 |
| Placebo | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 57 (n=44,40,43,45) | 4.57 units on a scale | Standard Deviation 1.03 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 127 (n=41,42,44,42) | 5.06 units on a scale | Standard Deviation 1.48 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall : Day 1 (n=41,41,44,39) | 3.96 units on a scale | Standard Deviation 0.89 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 29 (n=43,41,44,40) | 4.39 units on a scale | Standard Deviation 1.01 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 57 (n=44,40,43,45) | 4.56 units on a scale | Standard Deviation 1.15 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 92 (n=40,42,40,38) | 4.88 units on a scale | Standard Deviation 1.31 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 127 (n=41,42,44,42) | 4.76 units on a scale | Standard Deviation 1.29 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 169 (n=41,44,45,44) | 4.73 units on a scale | Standard Deviation 1.26 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 1 (n=41,41,44,39) | 3.89 units on a scale | Standard Deviation 0.84 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 29 (n=43,41,44,40) | 4.44 units on a scale | Standard Deviation 1.07 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 57 (n=44,40,43,45) | 4.68 units on a scale | Standard Deviation 1.23 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 92 (n=40,42,40,38) | 4.88 units on a scale | Standard Deviation 1.4 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 127 (n=41,42,44,42) | 4.79 units on a scale | Standard Deviation 1.31 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 169 (n=41,44,45,44) | 4.76 units on a scale | Standard Deviation 1.29 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 1 (n=41,41,44,39) | 4.07 units on a scale | Standard Deviation 0.88 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 29 (n=43,41,44,40) | 4.37 units on a scale | Standard Deviation 1.07 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 57 (n=44,40,43,45) | 4.42 units on a scale | Standard Deviation 1.09 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 92 (n=40,42,40,38) | 4.89 units on a scale | Standard Deviation 1.29 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 127 (n=41,42,44,42) | 4.77 units on a scale | Standard Deviation 1.32 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 169 (n=41,44,45,44) | 4.76 units on a scale | Standard Deviation 1.26 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 1 (n=41,41,44,39) | 4.20 units on a scale | Standard Deviation 1.18 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 29 (n=43,41,44,40) | 4.82 units on a scale | Standard Deviation 1.17 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 57 (n=44,40,43,45) | 4.98 units on a scale | Standard Deviation 1.42 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 92 (n=40,42,40,38) | 5.24 units on a scale | Standard Deviation 1.33 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 169 (n=41,44,45,44) | 5.00 units on a scale | Standard Deviation 1.5 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 1 (n=41,41,44,39) | 3.55 units on a scale | Standard Deviation 1.43 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 29 (n=43,41,44,40) | 3.75 units on a scale | Standard Deviation 1.48 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 57 (n=44,40,43,45) | 4.04 units on a scale | Standard Deviation 1.36 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 92 (n=40,42,40,38) | 4.44 units on a scale | Standard Deviation 1.63 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 127 (n=41,42,44,42) | 4.30 units on a scale | Standard Deviation 1.57 |
| CAT-354 150 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 169 (n=41,44,45,44) | 4.26 units on a scale | Standard Deviation 1.5 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 127 (n=41,42,44,42) | 4.98 units on a scale | Standard Deviation 1.4 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 29 (n=43,41,44,40) | 4.48 units on a scale | Standard Deviation 0.94 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 92 (n=40,42,40,38) | 4.74 units on a scale | Standard Deviation 1.15 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 169 (n=41,44,45,44) | 4.18 units on a scale | Standard Deviation 1.76 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 169 (n=41,44,45,44) | 5.06 units on a scale | Standard Deviation 1.39 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 92 (n=40,42,40,38) | 4.31 units on a scale | Standard Deviation 1.43 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 29 (n=43,41,44,40) | 4.82 units on a scale | Standard Deviation 1.22 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 127 (n=41,42,44,42) | 4.15 units on a scale | Standard Deviation 1.56 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 1 (n=41,41,44,39) | 3.70 units on a scale | Standard Deviation 1.11 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 29 (n=43,41,44,40) | 4.47 units on a scale | Standard Deviation 0.97 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 57 (n=44,40,43,45) | 4.47 units on a scale | Standard Deviation 1.05 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 169 (n=41,44,45,44) | 4.61 units on a scale | Standard Deviation 1.27 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 127 (n=41,42,44,42) | 4.69 units on a scale | Standard Deviation 1.09 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 169 (n=41,44,45,44) | 4.54 units on a scale | Standard Deviation 1.31 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 57 (n=44,40,43,45) | 4.87 units on a scale | Standard Deviation 1.24 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 29 (n=43,41,44,40) | 4.13 units on a scale | Standard Deviation 1.41 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 169 (n=41,44,45,44) | 4.63 units on a scale | Standard Deviation 1.26 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 92 (n=40,42,40,38) | 4.73 units on a scale | Standard Deviation 1.15 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 92 (n=40,42,40,38) | 4.78 units on a scale | Standard Deviation 1.17 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 1 (n=41,41,44,39) | 4.11 units on a scale | Standard Deviation 0.71 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 1 (n=41,41,44,39) | 4.13 units on a scale | Standard Deviation 0.97 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 127 (n=41,42,44,42) | 4.62 units on a scale | Standard Deviation 1.13 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 92 (n=40,42,40,38) | 4.99 units on a scale | Standard Deviation 1.45 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 1 (n=41,41,44,39) | 4.45 units on a scale | Standard Deviation 1.1 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 29 (n=43,41,44,40) | 4.42 units on a scale | Standard Deviation 1.08 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 127 (n=41,42,44,42) | 4.64 units on a scale | Standard Deviation 1.11 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 57 (n=44,40,43,45) | 4.49 units on a scale | Standard Deviation 1.05 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall : Day 1 (n=41,41,44,39) | 4.12 units on a scale | Standard Deviation 0.8 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 57 (n=44,40,43,45) | 4.41 units on a scale | Standard Deviation 1.14 |
| CAT-354 300 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 57 (n=44,40,43,45) | 4.09 units on a scale | Standard Deviation 1.43 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 57 (n=44,40,43,45) | 4.74 units on a scale | Standard Deviation 0.99 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 92 (n=40,42,40,38) | 4.91 units on a scale | Standard Deviation 1.04 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 57 (n=44,40,43,45) | 4.37 units on a scale | Standard Deviation 1.49 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 127 (n=41,42,44,42) | 4.66 units on a scale | Standard Deviation 1.08 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 1 (n=41,41,44,39) | 4.08 units on a scale | Standard Deviation 1.06 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 169 (n=41,44,45,44) | 4.70 units on a scale | Standard Deviation 1.14 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 169 (n=41,44,45,44) | 4.45 units on a scale | Standard Deviation 1.51 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 1 (n=41,41,44,39) | 4.29 units on a scale | Standard Deviation 1.24 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 169 (n=41,44,45,44) | 4.76 units on a scale | Standard Deviation 1.13 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 29 (n=43,41,44,40) | 4.88 units on a scale | Standard Deviation 1.17 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 92 (n=40,42,40,38) | 4.47 units on a scale | Standard Deviation 1.47 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 57 (n=44,40,43,45) | 4.99 units on a scale | Standard Deviation 1.13 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 127 (n=41,42,44,42) | 4.85 units on a scale | Standard Deviation 1.13 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall : Day 1 (n=41,41,44,39) | 4.11 units on a scale | Standard Deviation 0.94 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 92 (n=40,42,40,38) | 4.98 units on a scale | Standard Deviation 1.02 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 92 (n=40,42,40,38) | 4.87 units on a scale | Standard Deviation 0.99 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 127 (n=41,42,44,42) | 5.28 units on a scale | Standard Deviation 1.29 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Emotional Function: Day 169 (n=41,44,45,44) | 5.13 units on a scale | Standard Deviation 1.28 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 57 (n=44,40,43,45) | 4.73 units on a scale | Standard Deviation 0.96 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 1 (n=41,41,44,39) | 3.85 units on a scale | Standard Deviation 1.1 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 127 (n=41,42,44,42) | 4.51 units on a scale | Standard Deviation 1.64 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 127 (n=41,42,44,42) | 4.95 units on a scale | Standard Deviation 1.31 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 92 (n=40,42,40,38) | 4.92 units on a scale | Standard Deviation 1.01 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 169 (n=41,44,45,44) | 4.77 units on a scale | Standard Deviation 1.31 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Environment stimuli: Day 29 (n=43,41,44,40) | 4.40 units on a scale | Standard Deviation 1.2 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 1 (n=41,41,44,39) | 4.15 units on a scale | Standard Deviation 0.91 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 57 (n=44,40,43,45) | 4.73 units on a scale | Standard Deviation 1.05 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Overall: Day 29 (n=43,41,44,40) | 4.60 units on a scale | Standard Deviation 0.91 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Activity Limitation: Day 29 (n=43,41,44,40) | 4.59 units on a scale | Standard Deviation 0.92 |
| CAT-354 600 mg | Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores | Symptom: Day 29 (n=43,41,44,40) | 4.56 units on a scale | Standard Deviation 1.01 |
Secondary
Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169
Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ\[S\]): a 32-item questionnaire that measures the functional impairments experienced by adult participants including 4 domains (Symptoms, Activity Limitations, Emotional Function, and Environmental Stimuli). Participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score was calculated as the mean response to all questions. The 4 domain scores were the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment). Data collected on Day 1 prior to dosing was considered as baseline
Time frame: Day 1, 29, 57, 92, 127 and 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 29 (n=34,35,37,31) | 0.32 units on a scale | Standard Deviation 0.65 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 169 (n=31,37,37,34) | 0.52 units on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 92 (n=31,34,35,27) | 0.87 units on a scale | Standard Deviation 1.25 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 92 (n=31,34,35,27) | 0.76 units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 57 (n=33,33,35,34) | 0.69 units on a scale | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 92 (n=31,34,35,27) | 0.63 units on a scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 57 (n=33,33,35,34) | 0.36 units on a scale | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 127 (n=32,36,34,31) | 0.85 units on a scale | Standard Deviation 1.03 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 169 (n=31,37,37,34) | 0.38 units on a scale | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 169 (n=31,37,37,34) | 0.64 units on a scale | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 127 (n=32,36,34,31) | 0.43 units on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 169 (n=31,37,37,34) | 0.80 units on a scale | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 127 (n=32,36,34,31) | 0.64 units on a scale | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 57 (n=33,33,35,34) | 0.45 units on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 29 (n=34,35,37,31) | 0.40 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 29 (n=34,35,37,31) | 0.21 units on a scale | Standard Deviation 0.64 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 29 (n=34,35,37,31) | 0.31 units on a scale | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 29 (n=34,35,37,31) | 0.50 units on a scale | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 127 (n=32,36,34,31) | 1.02 units on a scale | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 57 (n=33,33,35,34) | 0.28 units on a scale | Standard Deviation 0.79 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 92 (n=31,34,35,27) | 0.54 units on a scale | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 127 (n=32,36,34,31) | 0.71 units on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 169 (n=31,37,37,34) | 0.88 units on a scale | Standard Deviation 1.42 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 92 (n=31,34,35,27) | 0.42 units on a scale | Standard Deviation 0.81 |
| Placebo | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 57 (n=33,33,35,34) | 0.52 units on a scale | Standard Deviation 0.86 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 92 (n=31,34,35,27) | 0.80 units on a scale | Standard Deviation 1.12 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 127 (n=32,36,34,31) | 0.87 units on a scale | Standard Deviation 1.38 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 127 (n=32,36,34,31) | 0.65 units on a scale | Standard Deviation 1.2 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 169 (n=31,37,37,34) | 0.68 units on a scale | Standard Deviation 1.16 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 92 (n=31,34,35,27) | 1.06 units on a scale | Standard Deviation 1.25 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 29 (n=34,35,37,31) | 0.57 units on a scale | Standard Deviation 0.76 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 57 (n=33,33,35,34) | 0.95 units on a scale | Standard Deviation 1.16 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 169 (n=31,37,37,34) | 0.78 units on a scale | Standard Deviation 1.19 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 57 (n=33,33,35,34) | 0.70 units on a scale | Standard Deviation 0.99 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 92 (n=31,34,35,27) | 0.97 units on a scale | Standard Deviation 1.68 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 29 (n=34,35,37,31) | 0.49 units on a scale | Standard Deviation 0.83 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 29 (n=34,35,37,31) | 0.38 units on a scale | Standard Deviation 0.64 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 57 (n=33,33,35,34) | 0.87 units on a scale | Standard Deviation 1.1 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 57 (n=33,33,35,34) | 0.58 units on a scale | Standard Deviation 1.39 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 92 (n=31,34,35,27) | 1.00 units on a scale | Standard Deviation 1.32 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 127 (n=32,36,34,31) | 0.87 units on a scale | Standard Deviation 1.24 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 92 (n=31,34,35,27) | 0.94 units on a scale | Standard Deviation 1.21 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 29 (n=34,35,37,31) | 0.16 units on a scale | Standard Deviation 0.78 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 169 (n=31,37,37,34) | 0.86 units on a scale | Standard Deviation 1.22 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 169 (n=31,37,37,34) | 0.75 units on a scale | Standard Deviation 1.55 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 29 (n=34,35,37,31) | 0.25 units on a scale | Standard Deviation 0.69 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 127 (n=32,36,34,31) | 0.74 units on a scale | Standard Deviation 1.68 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 169 (n=31,37,37,34) | 0.88 units on a scale | Standard Deviation 1.36 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 57 (n=33,33,35,34) | 0.44 units on a scale | Standard Deviation 0.89 |
| CAT-354 150 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 127 (n=32,36,34,31) | 0.78 units on a scale | Standard Deviation 1.21 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 29 (n=34,35,37,31) | 0.36 units on a scale | Standard Deviation 1.04 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 29 (n=34,35,37,31) | 0.39 units on a scale | Standard Deviation 0.88 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 57 (n=33,33,35,34) | 0.38 units on a scale | Standard Deviation 0.95 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 92 (n=31,34,35,27) | 0.52 units on a scale | Standard Deviation 1.07 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 127 (n=32,36,34,31) | 0.49 units on a scale | Standard Deviation 1.14 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 169 (n=31,37,37,34) | 0.56 units on a scale | Standard Deviation 1.09 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 29 (n=34,35,37,31) | 0.43 units on a scale | Standard Deviation 0.83 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 57 (n=33,33,35,34) | 0.44 units on a scale | Standard Deviation 0.85 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 92 (n=31,34,35,27) | 0.61 units on a scale | Standard Deviation 1.11 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 127 (n=32,36,34,31) | 0.56 units on a scale | Standard Deviation 1.14 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 169 (n=31,37,37,34) | 0.62 units on a scale | Standard Deviation 1.17 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 29 (n=34,35,37,31) | 0.32 units on a scale | Standard Deviation 0.96 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 57 (n=33,33,35,34) | 0.30 units on a scale | Standard Deviation 1.08 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 92 (n=31,34,35,27) | 0.51 units on a scale | Standard Deviation 1.12 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 127 (n=32,36,34,31) | 0.45 units on a scale | Standard Deviation 1.14 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 169 (n=31,37,37,34) | 0.44 units on a scale | Standard Deviation 1.09 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 57 (n=33,33,35,34) | 0.42 units on a scale | Standard Deviation 1.15 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 92 (n=31,34,35,27) | 0.43 units on a scale | Standard Deviation 1.26 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 127 (n=32,36,34,31) | 0.41 units on a scale | Standard Deviation 1.32 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 169 (n=31,37,37,34) | 0.63 units on a scale | Standard Deviation 1.2 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 29 (n=34,35,37,31) | 0.47 units on a scale | Standard Deviation 1.18 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 57 (n=33,33,35,34) | 0.38 units on a scale | Standard Deviation 1.27 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 92 (n=31,34,35,27) | 0.42 units on a scale | Standard Deviation 1.17 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 127 (n=32,36,34,31) | 0.48 units on a scale | Standard Deviation 1.45 |
| CAT-354 300 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 169 (n=31,37,37,34) | 0.58 units on a scale | Standard Deviation 1.3 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 127 (n=32,36,34,31) | 1.32 units on a scale | Standard Deviation 1.42 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 57 (n=33,33,35,34) | 0.71 units on a scale | Standard Deviation 1.07 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 29 (n=34,35,37,31) | 0.57 units on a scale | Standard Deviation 0.9 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 169 (n=31,37,37,34) | 0.74 units on a scale | Standard Deviation 1.39 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 169 (n=31,37,37,34) | 0.95 units on a scale | Standard Deviation 1.4 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 169 (n=31,37,37,34) | 0.77 units on a scale | Standard Deviation 1.34 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 127 (n=32,36,34,31) | 1.24 units on a scale | Standard Deviation 1.23 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 127 (n=32,36,34,31) | 1.02 units on a scale | Standard Deviation 1.22 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 29 (n=34,35,37,31) | 0.76 units on a scale | Standard Deviation 0.8 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 92 (n=31,34,35,27) | 1.14 units on a scale | Standard Deviation 1.39 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 57 (n=33,33,35,34) | 0.81 units on a scale | Standard Deviation 1.11 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 57 (n=33,33,35,34) | 0.77 units on a scale | Standard Deviation 1.04 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 57 (n=33,33,35,34) | 0.65 units on a scale | Standard Deviation 1.4 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Symptom: Day 29 (n=34,35,37,31) | 0.62 units on a scale | Standard Deviation 0.8 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 169 (n=31,37,37,34) | 0.75 units on a scale | Standard Deviation 1.26 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 29 (n=34,35,37,31) | 0.66 units on a scale | Standard Deviation 0.76 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Environmental Stimuli: Day 92 (n=31,34,35,27) | 0.94 units on a scale | Standard Deviation 1.28 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 57 (n=33,33,35,34) | 0.86 units on a scale | Standard Deviation 1.21 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 29 (n=34,35,37,31) | 0.86 units on a scale | Standard Deviation 0.97 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 169 (n=31,37,37,34) | 0.65 units on a scale | Standard Deviation 1.37 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 127 (n=32,36,34,31) | 1.05 units on a scale | Standard Deviation 1.15 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Emotional Function: Day 92 (n=31,34,35,27) | 0.93 units on a scale | Standard Deviation 1.39 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 127 (n=32,36,34,31) | 0.72 units on a scale | Standard Deviation 1.28 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Activity Limitation: Day 92 (n=31,34,35,27) | 1.04 units on a scale | Standard Deviation 1.26 |
| CAT-354 600 mg | Change From Baseline in Asthma Quality of Life Questionnaire (Standardized Version) (AQLQ[S]) Scores at Day 29, 57, 92, 127 and 169 | Overall: Day 92 (n=31,34,35,27) | 1.05 units on a scale | Standard Deviation 1.25 |
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Forced Expiratory Volume in 1 Second (FEV1) is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Spirometry was performed with the participant in the sitting/standing (kept consistent at each visit) position at study sites by the investigator or qualified designee according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines. Multiple forced expiratory efforts (at least 3 but no more than 8) were performed for each office spirometry session and the 2 best efforts that met ATS/ERS acceptability and reproducibility criteria were recorded. The best efforts were based on the highest FEV1. The maximum FEV1 of the 2 best efforts was used for the analysis. Data collected on Day 1 prior to dosing was considered as baseline.
Time frame: Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 169 (n=42,42,47,47) | 0.101 liters | Standard Deviation 0.442 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 92 (n=42,44,49,44) | 0.063 liters | Standard Deviation 0.476 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 71 (n=45,45,49,47) | 0.047 liters | Standard Deviation 0.397 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 15 (n=44,46,50,46) | 0.019 liters | Standard Deviation 0.42 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 85 (n=45,46,48,47) | 0.087 liters | Standard Deviation 0.397 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Day 1 (n=46,46,51,47) | 1.949 liters | Standard Deviation 0.479 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 29 (n=46,46,49,47) | 0.051 liters | Standard Deviation 0.424 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 127 (n=44,44,49,47) | 0.094 liters | Standard Deviation 0.489 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 43 (n=45,44,47,47) | 0.125 liters | Standard Deviation 0.399 |
| Placebo | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 57 (n=45,46,49,47) | 0.043 liters | Standard Deviation 0.436 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 169 (n=42,42,47,47) | 0.204 liters | Standard Deviation 0.378 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 29 (n=46,46,49,47) | 0.138 liters | Standard Deviation 0.315 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Day 1 (n=46,46,51,47) | 2.178 liters | Standard Deviation 0.661 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 71 (n=45,45,49,47) | 0.158 liters | Standard Deviation 0.314 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 92 (n=42,44,49,44) | 0.158 liters | Standard Deviation 0.348 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 85 (n=45,46,48,47) | 0.135 liters | Standard Deviation 0.342 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 57 (n=45,46,49,47) | 0.127 liters | Standard Deviation 0.339 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 15 (n=44,46,50,46) | 0.122 liters | Standard Deviation 0.316 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 43 (n=45,44,47,47) | 0.131 liters | Standard Deviation 0.38 |
| CAT-354 150 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 127 (n=44,44,49,47) | 0.144 liters | Standard Deviation 0.263 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 57 (n=45,46,49,47) | 0.187 liters | Standard Deviation 0.349 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Day 1 (n=46,46,51,47) | 1.907 liters | Standard Deviation 0.586 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 15 (n=44,46,50,46) | 0.116 liters | Standard Deviation 0.378 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 29 (n=46,46,49,47) | 0.149 liters | Standard Deviation 0.303 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 43 (n=45,44,47,47) | 0.164 liters | Standard Deviation 0.358 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 169 (n=42,42,47,47) | 0.211 liters | Standard Deviation 0.394 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 71 (n=45,45,49,47) | 0.179 liters | Standard Deviation 0.381 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 85 (n=45,46,48,47) | 0.286 liters | Standard Deviation 0.393 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 92 (n=42,44,49,44) | 0.211 liters | Standard Deviation 0.374 |
| CAT-354 300 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 127 (n=44,44,49,47) | 0.241 liters | Standard Deviation 0.381 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 57 (n=45,46,49,47) | 0.201 liters | Standard Deviation 0.344 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 43 (n=45,44,47,47) | 0.147 liters | Standard Deviation 0.373 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Day 1 (n=46,46,51,47) | 1.977 liters | Standard Deviation 0.646 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 92 (n=42,44,49,44) | 0.262 liters | Standard Deviation 0.408 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 29 (n=46,46,49,47) | 0.222 liters | Standard Deviation 0.354 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 15 (n=44,46,50,46) | 0.134 liters | Standard Deviation 0.348 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 169 (n=42,42,47,47) | 0.236 liters | Standard Deviation 0.366 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 71 (n=45,45,49,47) | 0.190 liters | Standard Deviation 0.335 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 127 (n=44,44,49,47) | 0.237 liters | Standard Deviation 0.285 |
| CAT-354 600 mg | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Recorded at Study Sites at Day 1, 15, 29, 43, 57, 71, 85, 92, 127 and 169 | Change at Day 85 (n=45,46,48,47) | 0.265 liters | Standard Deviation 0.473 |
Secondary
Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Home peak flow testing for PEF was performed every morning while sitting or standing prior to using any medication (if needed) for asthma. Mean of the data was collected over 1 week prior to dosing on Day 1 was considered as baseline. Mean PEF values for each week were used to calculate the change from baseline values starting from Day 2 to 169.
Time frame: Day -7 to 1 (predose), Day 2 to 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 107 to 113 (n=44,45,48,47) | -7.53 liters/minute | Standard Deviation 56.29 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 100 to 106 (n=44,46,49,47) | -9.60 liters/minute | Standard Deviation 55.47 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 51 to 57 (n=45,46,50,47) | -7.00 liters/minute | Standard Deviation 41.7 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 156 to 162 (n=40,45,46,46) | -1.38 liters/minute | Standard Deviation 65.53 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 44 to 50 (n=44,46,50,47) | -6.37 liters/minute | Standard Deviation 41.5 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 121 to 127 (n=42,46,46,46) | -3.58 liters/minute | Standard Deviation 65.64 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 79 to 85 (n=45,45,50,46) | -10.83 liters/minute | Standard Deviation 43.99 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 163 to 169 (n=37,41,42,40) | -0.36 liters/minute | Standard Deviation 58.66 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 30 to 36 (n=45,46,51,47) | -5.69 liters/minute | Standard Deviation 44.69 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 135 to 141 (n=40,45,47,47) | -0.26 liters/minute | Standard Deviation 58.83 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 23 to 29 (n=44,46,51,47) | -10.53 liters/minute | Standard Deviation 40.06 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Day -7 to 1 (n=46,46,51,47) | 282.63 liters/minute | Standard Deviation 100.65 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 93 to 99 (n=45,46,50,47) | -2.52 liters/minute | Standard Deviation 47.94 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 114 to 120 (n=42,45,47,47) | -2.19 liters/minute | Standard Deviation 61.74 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 72 to 78 (n=44,45,50,47) | -3.72 liters/minute | Standard Deviation 44.07 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 2 to 8 (n=44,46,51,47) | -5.77 liters/minute | Standard Deviation 22.74 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 142 to 148 (n=40,45,47,47) | 5.16 liters/minute | Standard Deviation 66.54 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 37 to 43 (n=44,46,50,47) | -11.08 liters/minute | Standard Deviation 41.52 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 58 to 64 (n=45,46,50,46) | -9.84 liters/minute | Standard Deviation 38.73 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 9 to 15 (n=45,46,51,47) | -7.46 liters/minute | Standard Deviation 29.68 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 86 to 92 (n=45,46,50,47) | -3.26 liters/minute | Standard Deviation 47.36 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 128 to 134 (n=42,45,45,47) | -4.39 liters/minute | Standard Deviation 61.22 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 65 to 71 (n=45,46,50,46) | -11.81 liters/minute | Standard Deviation 43.87 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 16 to 22 (n=45,46,51,47) | -8.94 liters/minute | Standard Deviation 35.72 |
| Placebo | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 149 to 155 (n=40,45,46,47) | 0.43 liters/minute | Standard Deviation 60.53 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 16 to 22 (n=45,46,51,47) | -6.53 liters/minute | Standard Deviation 32.7 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 58 to 64 (n=45,46,50,46) | -2.83 liters/minute | Standard Deviation 47.42 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 23 to 29 (n=44,46,51,47) | -6.61 liters/minute | Standard Deviation 37.95 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 30 to 36 (n=45,46,51,47) | -5.69 liters/minute | Standard Deviation 41.87 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 51 to 57 (n=45,46,50,47) | -6.01 liters/minute | Standard Deviation 47.36 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 37 to 43 (n=44,46,50,47) | -2.00 liters/minute | Standard Deviation 49.76 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 44 to 50 (n=44,46,50,47) | -9.02 liters/minute | Standard Deviation 47.51 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 135 to 141 (n=40,45,47,47) | -17.03 liters/minute | Standard Deviation 58.99 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 114 to 120 (n=42,45,47,47) | -8.97 liters/minute | Standard Deviation 55.61 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 86 to 92 (n=45,46,50,47) | -6.66 liters/minute | Standard Deviation 51.23 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 142 to 148 (n=40,45,47,47) | -11.63 liters/minute | Standard Deviation 61.02 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 107 to 113 (n=44,45,48,47) | -11.29 liters/minute | Standard Deviation 57.33 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 149 to 155 (n=40,45,46,47) | -9.56 liters/minute | Standard Deviation 60.13 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 79 to 85 (n=45,45,50,46) | -6.67 liters/minute | Standard Deviation 54.49 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 156 to 162 (n=40,45,46,46) | -11.60 liters/minute | Standard Deviation 62.14 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 163 to 169 (n=37,41,42,40) | -5.68 liters/minute | Standard Deviation 60.69 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 121 to 127 (n=42,46,46,46) | -8.99 liters/minute | Standard Deviation 64.6 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 72 to 78 (n=44,45,50,47) | -3.42 liters/minute | Standard Deviation 53.55 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Day -7 to 1 (n=46,46,51,47) | 351.06 liters/minute | Standard Deviation 130.41 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 100 to 106 (n=44,46,49,47) | -7.33 liters/minute | Standard Deviation 52.64 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 2 to 8 (n=44,46,51,47) | 1.91 liters/minute | Standard Deviation 23.81 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 93 to 99 (n=45,46,50,47) | -4.99 liters/minute | Standard Deviation 49.91 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 65 to 71 (n=45,46,50,46) | -3.98 liters/minute | Standard Deviation 47.2 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 9 to 15 (n=45,46,51,47) | -4.10 liters/minute | Standard Deviation 28.15 |
| CAT-354 150 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 128 to 134 (n=42,45,45,47) | -14.81 liters/minute | Standard Deviation 61.39 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 37 to 43 (n=44,46,50,47) | -4.07 liters/minute | Standard Deviation 39.8 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 107 to 113 (n=44,45,48,47) | 0.53 liters/minute | Standard Deviation 45.6 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 114 to 120 (n=42,45,47,47) | 4.85 liters/minute | Standard Deviation 39.54 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 121 to 127 (n=42,46,46,46) | 3.61 liters/minute | Standard Deviation 46.18 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 128 to 134 (n=42,45,45,47) | 4.62 liters/minute | Standard Deviation 44.65 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 135 to 141 (n=40,45,47,47) | 1.11 liters/minute | Standard Deviation 44.36 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 142 to 148 (n=40,45,47,47) | -2.69 liters/minute | Standard Deviation 51.65 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 149 to 155 (n=40,45,46,47) | -7.65 liters/minute | Standard Deviation 47.44 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 156 to 162 (n=40,45,46,46) | -10.05 liters/minute | Standard Deviation 43.11 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 163 to 169 (n=37,41,42,40) | -4.71 liters/minute | Standard Deviation 49.29 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Day -7 to 1 (n=46,46,51,47) | 291.54 liters/minute | Standard Deviation 119.46 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 2 to 8 (n=44,46,51,47) | -4.53 liters/minute | Standard Deviation 19.02 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 9 to 15 (n=45,46,51,47) | -2.83 liters/minute | Standard Deviation 24.4 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 16 to 22 (n=45,46,51,47) | -0.37 liters/minute | Standard Deviation 33.85 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 23 to 29 (n=44,46,51,47) | -0.79 liters/minute | Standard Deviation 36.94 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 30 to 36 (n=45,46,51,47) | -1.98 liters/minute | Standard Deviation 36.06 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 44 to 50 (n=44,46,50,47) | -5.30 liters/minute | Standard Deviation 36.57 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 51 to 57 (n=45,46,50,47) | -4.85 liters/minute | Standard Deviation 41.27 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 58 to 64 (n=45,46,50,46) | -1.42 liters/minute | Standard Deviation 41.9 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 65 to 71 (n=45,46,50,46) | -0.92 liters/minute | Standard Deviation 49.95 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 72 to 78 (n=44,45,50,47) | 2.54 liters/minute | Standard Deviation 45.58 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 79 to 85 (n=45,45,50,46) | -0.35 liters/minute | Standard Deviation 40.29 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 86 to 92 (n=45,46,50,47) | 5.04 liters/minute | Standard Deviation 40.52 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 93 to 99 (n=45,46,50,47) | 5.16 liters/minute | Standard Deviation 40.99 |
| CAT-354 300 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 100 to 106 (n=44,46,49,47) | 1.93 liters/minute | Standard Deviation 43.08 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 58 to 64 (n=45,46,50,46) | -0.73 liters/minute | Standard Deviation 55.98 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 9 to 15 (n=45,46,51,47) | 5.75 liters/minute | Standard Deviation 42.34 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 2 to 8 (n=44,46,51,47) | 5.94 liters/minute | Standard Deviation 29.93 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 100 to 106 (n=44,46,49,47) | 2.00 liters/minute | Standard Deviation 62.18 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 65 to 71 (n=45,46,50,46) | -1.82 liters/minute | Standard Deviation 49.79 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Day -7 to 1 (n=46,46,51,47) | 325.23 liters/minute | Standard Deviation 123.9 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 163 to 169 (n=37,41,42,40) | -3.23 liters/minute | Standard Deviation 66.84 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 93 to 99 (n=45,46,50,47) | 7.81 liters/minute | Standard Deviation 58.29 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 72 to 78 (n=44,45,50,47) | 1.78 liters/minute | Standard Deviation 49.45 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 156 to 162 (n=40,45,46,46) | -10.68 liters/minute | Standard Deviation 66.86 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 149 to 155 (n=40,45,46,47) | -11.07 liters/minute | Standard Deviation 62.16 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 114 to 120 (n=42,45,47,47) | -3.03 liters/minute | Standard Deviation 59.68 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 79 to 85 (n=45,45,50,46) | 5.30 liters/minute | Standard Deviation 60.62 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 142 to 148 (n=40,45,47,47) | -9.65 liters/minute | Standard Deviation 65.62 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 135 to 141 (n=40,45,47,47) | -6.03 liters/minute | Standard Deviation 63.13 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 107 to 113 (n=44,45,48,47) | 0.39 liters/minute | Standard Deviation 61.52 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 86 to 92 (n=45,46,50,47) | 0.31 liters/minute | Standard Deviation 62.86 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 44 to 50 (n=44,46,50,47) | -0.84 liters/minute | Standard Deviation 50.67 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 37 to 43 (n=44,46,50,47) | 5.55 liters/minute | Standard Deviation 54.28 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 30 to 36 (n=45,46,51,47) | 6.52 liters/minute | Standard Deviation 50.15 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 128 to 134 (n=42,45,45,47) | -2.64 liters/minute | Standard Deviation 56.87 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 51 to 57 (n=45,46,50,47) | -3.57 liters/minute | Standard Deviation 52.84 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 23 to 29 (n=44,46,51,47) | 10.61 liters/minute | Standard Deviation 52.64 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 16 to 22 (n=45,46,51,47) | 10.55 liters/minute | Standard Deviation 51.26 |
| CAT-354 600 mg | Change From Baseline in Peak Expiratory Flow (PEF) Recorded at Home Every Week From Day 1 to 169 | Change in Day 121 to 127 (n=42,46,46,46) | -4.21 liters/minute | Standard Deviation 57.88 |
Secondary
Moderate or Severe Asthma Exacerbations Per Person Per Annum
Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation rate, calculated as total asthma exacerbations per person per annum, was assessed based on asthma exacerbation data up to Day 92 and 169 (Rate = mean asthma exacerbations for all participants/X days\*365 days, where X = 92 or 169).
Time frame: Day 1 to Day 92 and Day 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 92 | 0.26 asthma exacerbations/person/annum | Standard Error 0.19 |
| Placebo | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 169 | 0.23 asthma exacerbations/person/annum | Standard Error 0.19 |
| CAT-354 150 mg | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 169 | 0.14 asthma exacerbations/person/annum | Standard Error 0.1 |
| CAT-354 150 mg | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 92 | 0.09 asthma exacerbations/person/annum | Standard Error 0.09 |
| CAT-354 300 mg | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 92 | 0.08 asthma exacerbations/person/annum | Standard Error 0.08 |
| CAT-354 300 mg | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 169 | 0.08 asthma exacerbations/person/annum | Standard Error 0.06 |
| CAT-354 600 mg | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 92 | 0.25 asthma exacerbations/person/annum | Standard Error 0.19 |
| CAT-354 600 mg | Moderate or Severe Asthma Exacerbations Per Person Per Annum | Day 1 to 169 | 0.19 asthma exacerbations/person/annum | Standard Error 0.11 |
p-value: 0.551Van Elteren Test
p-value: 0.492Van Elteren Test
p-value: 0.983Van Elteren Test
p-value: 0.991Van Elteren Test
p-value: 0.9Van Elteren Test
p-value: 0.673Van Elteren Test
Secondary
Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit
Time frame: Day 1, 92 and 169
Population: Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit | 0 participants |
| CAT-354 150 mg | Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit | 0 participants |
| CAT-354 300 mg | Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit | 0 participants |
| CAT-354 600 mg | Number of Participants With Anti-Drug Antibodies to CAT-354 at Any Visit | 0 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Day 1 to 169
Population: Safety population included all participants who received any dose of the investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 17 participants |
| Placebo | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 3 participants |
| CAT-354 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 2 participants |
| CAT-354 150 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 20 participants |
| CAT-354 300 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 25 participants |
| CAT-354 300 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 0 participants |
| CAT-354 600 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TEAEs | 25 participants |
| CAT-354 600 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | TESAEs | 1 participants |
Secondary
Number of Puffs of Rescue Beta-2 Agonist Per Week
Number of Puffs of Rescue Beta-2 Agonist Per Week Rescue beta-2 agonist use (total number of puffs for the preceding week) was collected daily in the morning by the participants in the daily diary provided to them. Average values for each week were reported starting from Day -7 to Day 169.
Time frame: Day -7 to 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 79 to 85 (n=46,46, 50,46) | 2.6 puffs per week | Standard Deviation 2.3 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 16 to 22 (n=46,46, 51,47) | 2.6 puffs per week | Standard Deviation 1.9 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 86 to 92 (n=46,46, 50,47) | 2.5 puffs per week | Standard Deviation 2.3 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 121 to 127 (n=43,46, 46,47) | 2.2 puffs per week | Standard Deviation 1.9 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 93 to 99 (n=46,46, 50,47) | 2.4 puffs per week | Standard Deviation 2.2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 100 to 106 (n=45,46, 49,47) | 2.3 puffs per week | Standard Deviation 2.1 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 156 to 162 (n=42,45, 46,46) | 2.3 puffs per week | Standard Deviation 2.1 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 114 to 120 (n=43,45, 47,47) | 2.3 puffs per week | Standard Deviation 2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 107 to 113 (n=45,45, 48,47) | 2.4 puffs per week | Standard Deviation 2.1 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 23 to 29 (n=45,46, 51,47) | 2.7 puffs per week | Standard Deviation 2.1 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 2 to 8 (n=45,46, 51,47) | 2.5 puffs per week | Standard Deviation 1.8 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 149 to 155 (n=42,45, 46,47) | 2.4 puffs per week | Standard Deviation 2.2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 30 to 36 (n=46,46, 51,47) | 2.5 puffs per week | Standard Deviation 2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 37 to 43 (n=45,46, 50,47) | 2.4 puffs per week | Standard Deviation 2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 142 to 148 (n=42,45, 47,47) | 2.3 puffs per week | Standard Deviation 2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 44 to 50 (n=45,46, 50,47) | 2.5 puffs per week | Standard Deviation 2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 163 to 169 (n=39,41,42,40) | 2.7 puffs per week | Standard Deviation 2.6 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 51 to 57 (n=45,46, 50,47) | 2.5 puffs per week | Standard Deviation 2.1 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 9 to 15 (n=46,46, 51,47) | 2.4 puffs per week | Standard Deviation 1.8 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 135 to 141 (n=42,45, 47,47) | 2.2 puffs per week | Standard Deviation 2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 58 to 64 (n=46,46, 49,46) | 2.5 puffs per week | Standard Deviation 2.2 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 65 to 71 (n=46,46, 50,47) | 2.7 puffs per week | Standard Deviation 2.3 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day -7 to 1 (n=46,46, 51,47) | 2.58 puffs per week | Standard Deviation 1.7 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 128 to 134 (n=44,45, 47,47) | 2.2 puffs per week | Standard Deviation 2.1 |
| Placebo | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 72 to 78 (n=45,45, 50,46) | 2.5 puffs per week | Standard Deviation 2.2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 58 to 64 (n=46,46, 49,46) | 1.9 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 37 to 43 (n=45,46, 50,47) | 2.1 puffs per week | Standard Deviation 2.2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 121 to 127 (n=43,46, 46,47) | 1.9 puffs per week | Standard Deviation 2.2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day -7 to 1 (n=46,46, 51,47) | 2.84 puffs per week | Standard Deviation 2.03 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 86 to 92 (n=46,46, 50,47) | 2.0 puffs per week | Standard Deviation 2.1 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 16 to 22 (n=46,46, 51,47) | 2.2 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 9 to 15 (n=46,46, 51,47) | 2.5 puffs per week | Standard Deviation 2.3 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 128 to 134 (n=44,45, 47,47) | 1.8 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 93 to 99 (n=46,46, 50,47) | 1.7 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 163 to 169 (n=39,41,42,40) | 1.9 puffs per week | Standard Deviation 2.1 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 114 to 120 (n=43,45, 47,47) | 1.9 puffs per week | Standard Deviation 2.1 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 44 to 50 (n=45,46, 50,47) | 1.9 puffs per week | Standard Deviation 2.2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 100 to 106 (n=45,46, 49,47) | 1.9 puffs per week | Standard Deviation 2.2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 72 to 78 (n=45,45, 50,46) | 2.0 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 135 to 141 (n=42,45, 47,47) | 1.9 puffs per week | Standard Deviation 1.9 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 65 to 71 (n=46,46, 50,47) | 2.0 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 107 to 113 (n=45,45, 48,47) | 1.9 puffs per week | Standard Deviation 2.2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 51 to 57 (n=45,46, 50,47) | 2.0 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 23 to 29 (n=45,46, 51,47) | 2.2 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 156 to 162 (n=42,45, 46,46) | 1.9 puffs per week | Standard Deviation 2.1 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 149 to 155 (n=42,45, 46,47) | 1.9 puffs per week | Standard Deviation 2.1 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 79 to 85 (n=46,46, 50,46) | 2.1 puffs per week | Standard Deviation 2.1 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 30 to 36 (n=46,46, 51,47) | 2.1 puffs per week | Standard Deviation 2.2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 2 to 8 (n=45,46, 51,47) | 2.4 puffs per week | Standard Deviation 2 |
| CAT-354 150 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 142 to 148 (n=42,45, 47,47) | 1.9 puffs per week | Standard Deviation 2.1 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 121 to 127 (n=43,46, 46,47) | 1.8 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day -7 to 1 (n=46,46, 51,47) | 2.04 puffs per week | Standard Deviation 1.51 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 2 to 8 (n=45,46, 51,47) | 1.9 puffs per week | Standard Deviation 1.5 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 9 to 15 (n=46,46, 51,47) | 1.9 puffs per week | Standard Deviation 1.5 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 16 to 22 (n=46,46, 51,47) | 1.9 puffs per week | Standard Deviation 1.7 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 23 to 29 (n=45,46, 51,47) | 2.0 puffs per week | Standard Deviation 1.9 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 30 to 36 (n=46,46, 51,47) | 1.9 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 37 to 43 (n=45,46, 50,47) | 1.9 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 44 to 50 (n=45,46, 50,47) | 1.7 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 51 to 57 (n=45,46, 50,47) | 1.8 puffs per week | Standard Deviation 1.9 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 58 to 64 (n=46,46, 49,46) | 1.9 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 65 to 71 (n=46,46, 50,47) | 1.8 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 72 to 78 (n=45,45, 50,46) | 1.8 puffs per week | Standard Deviation 2.1 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 79 to 85 (n=46,46, 50,46) | 1.9 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 86 to 92 (n=46,46, 50,47) | 1.8 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 93 to 99 (n=46,46, 50,47) | 1.8 puffs per week | Standard Deviation 2.1 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 100 to 106 (n=45,46, 49,47) | 1.7 puffs per week | Standard Deviation 2.2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 107 to 113 (n=45,45, 48,47) | 1.7 puffs per week | Standard Deviation 1.9 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 114 to 120 (n=43,45, 47,47) | 1.7 puffs per week | Standard Deviation 1.9 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 128 to 134 (n=44,45, 47,47) | 1.6 puffs per week | Standard Deviation 1.9 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 135 to 141 (n=42,45, 47,47) | 1.7 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 142 to 148 (n=42,45, 47,47) | 1.8 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 149 to 155 (n=42,45, 46,47) | 1.8 puffs per week | Standard Deviation 2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 156 to 162 (n=42,45, 46,46) | 1.7 puffs per week | Standard Deviation 2.2 |
| CAT-354 300 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 163 to 169 (n=39,41,42,40) | 1.6 puffs per week | Standard Deviation 1.8 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 72 to 78 (n=45,45, 50,46) | 1.9 puffs per week | Standard Deviation 1.8 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 121 to 127 (n=43,46, 46,47) | 1.6 puffs per week | Standard Deviation 1.6 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 65 to 71 (n=46,46, 50,47) | 2.0 puffs per week | Standard Deviation 1.9 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 58 to 64 (n=46,46, 49,46) | 1.8 puffs per week | Standard Deviation 2 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 163 to 169 (n=39,41,42,40) | 1.7 puffs per week | Standard Deviation 1.9 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 128 to 134 (n=44,45, 47,47) | 1.6 puffs per week | Standard Deviation 1.7 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 51 to 57 (n=45,46, 50,47) | 2.0 puffs per week | Standard Deviation 2.1 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 44 to 50 (n=45,46, 50,47) | 2.0 puffs per week | Standard Deviation 2 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 156 to 162 (n=42,45, 46,46) | 2.0 puffs per week | Standard Deviation 2 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 135 to 141 (n=42,45, 47,47) | 1.7 puffs per week | Standard Deviation 1.8 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 37 to 43 (n=45,46, 50,47) | 2.0 puffs per week | Standard Deviation 2 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 30 to 36 (n=46,46, 51,47) | 2.0 puffs per week | Standard Deviation 1.9 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 2 to 8 (n=45,46, 51,47) | 2.3 puffs per week | Standard Deviation 2 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 142 to 148 (n=42,45, 47,47) | 1.8 puffs per week | Standard Deviation 1.8 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 23 to 29 (n=45,46, 51,47) | 2.2 puffs per week | Standard Deviation 2.1 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day -7 to 1 (n=46,46, 51,47) | 2.62 puffs per week | Standard Deviation 1.96 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 149 to 155 (n=42,45, 46,47) | 1.8 puffs per week | Standard Deviation 1.8 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 16 to 22 (n=46,46, 51,47) | 2.3 puffs per week | Standard Deviation 2.2 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 107 to 113 (n=45,45, 48,47) | 1.7 puffs per week | Standard Deviation 1.6 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 100 to 106 (n=45,46, 49,47) | 1.8 puffs per week | Standard Deviation 1.8 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 93 to 99 (n=46,46, 50,47) | 1.6 puffs per week | Standard Deviation 1.8 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 9 to 15 (n=46,46, 51,47) | 2.2 puffs per week | Standard Deviation 2 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 114 to 120 (n=43,45, 47,47) | 1.7 puffs per week | Standard Deviation 1.7 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 86 to 92 (n=46,46, 50,47) | 1.7 puffs per week | Standard Deviation 1.7 |
| CAT-354 600 mg | Number of Puffs of Rescue Beta-2 Agonist Per Week | Day 79 to 85 (n=46,46, 50,46) | 1.8 puffs per week | Standard Deviation 1.8 |
Secondary
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (PGIC): participant rated instrument to measure participant's change in overall status compared to baseline on a 7-point scale; range from 1 (very much worse) to 7 (very much better).
Time frame: Day 92 and 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Here, 'n' signifies those participants who were evaluable for this measure at specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Patient Global Impression of Change (PGIC) | Day 92 (n=40,42,40,38) | 5.1 units on a scale | Standard Deviation 1.1 |
| Placebo | Patient Global Impression of Change (PGIC) | Day 169 (n=42,44,45,44) | 5.1 units on a scale | Standard Deviation 1.1 |
| CAT-354 150 mg | Patient Global Impression of Change (PGIC) | Day 169 (n=42,44,45,44) | 5.3 units on a scale | Standard Deviation 1.1 |
| CAT-354 150 mg | Patient Global Impression of Change (PGIC) | Day 92 (n=40,42,40,38) | 5.3 units on a scale | Standard Deviation 1.1 |
| CAT-354 300 mg | Patient Global Impression of Change (PGIC) | Day 169 (n=42,44,45,44) | 5.0 units on a scale | Standard Deviation 1 |
| CAT-354 300 mg | Patient Global Impression of Change (PGIC) | Day 92 (n=40,42,40,38) | 5.3 units on a scale | Standard Deviation 1 |
| CAT-354 600 mg | Patient Global Impression of Change (PGIC) | Day 169 (n=42,44,45,44) | 5.1 units on a scale | Standard Deviation 1.3 |
| CAT-354 600 mg | Patient Global Impression of Change (PGIC) | Day 92 (n=40,42,40,38) | 5.2 units on a scale | Standard Deviation 1.2 |
Secondary
Percentage of Participants With at Least 1 Moderate or Severe Exacerbation
Asthma exacerbation was defined as either a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>= 20 percent (%) in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider. Asthma exacerbation severity was classified as: 1) Moderate-worsening symptoms that required systemic corticosteroids. 2) Severe-worsening symptoms that required systemic corticosteroids and hospital admission.
Time frame: Day 92 and 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. No separate analyses were performed for moderate and severe exacerbations since only 1 participant had a severe exacerbation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 92 | 4.3 Percentage of Participants |
| Placebo | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 169 | 4.3 Percentage of Participants |
| CAT-354 150 mg | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 169 | 4.3 Percentage of Participants |
| CAT-354 150 mg | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 92 | 2.2 Percentage of Participants |
| CAT-354 300 mg | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 92 | 2.0 Percentage of Participants |
| CAT-354 300 mg | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 169 | 3.9 Percentage of Participants |
| CAT-354 600 mg | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 92 | 4.3 Percentage of Participants |
| CAT-354 600 mg | Percentage of Participants With at Least 1 Moderate or Severe Exacerbation | Day 169 | 6.4 Percentage of Participants |
p-value: 1Fisher Exact
p-value: 0.6022Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
p-value: 1Fisher Exact
Secondary
Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5
Percentage of participants with mean Asthma Control Questionnaire (ACQ) score less than or equal to (\<=) 0.75 or mean ACQ score greater than (\>) 0.75 and less than (\<) 1.5 were analyzed. The ACQ is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled). Mean ACQ scores of less than or equal to (\<=) 0.75 indicated well-controlled asthma, mean ACQ scores greater than (\>) 0.75 but less than (\<) 1.5 indicated partly controlled asthma.
Time frame: Day 92 and 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 92 | 13.0 percentage of participants | 19.6 |
| Placebo | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 92 | 15.2 percentage of participants | — |
| Placebo | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 169 | 13.0 percentage of participants | — |
| Placebo | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 169 | 21.7 percentage of participants | — |
| CAT-354 150 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 92 | 13.0 percentage of participants | — |
| CAT-354 150 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 169 | 19.6 percentage of participants | — |
| CAT-354 150 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 169 | 10.9 percentage of participants | — |
| CAT-354 150 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 92 | 19.6 percentage of participants | — |
| CAT-354 300 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 169 | 13.7 percentage of participants | — |
| CAT-354 300 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 92 | 15.7 percentage of participants | — |
| CAT-354 300 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 169 | 17.6 percentage of participants | — |
| CAT-354 300 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 92 | 11.8 percentage of participants | — |
| CAT-354 600 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 169 | 19.1 percentage of participants | — |
| CAT-354 600 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score>0.75 and <1.5: Day 92 | 19.1 percentage of participants | — |
| CAT-354 600 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 92 | 17.0 percentage of participants | — |
| CAT-354 600 mg | Percentage of Participants With Mean Asthma Control Questionnaire (ACQ) Score Less Than or Equal to 0.75 or ACQ Score Greater Than 0.75 But Less Than 1.5 | ACQ score<=0.75: Day 169 | 19.1 percentage of participants | — |
p-value: 0.934Fisher Exact
p-value: 0.592Fisher Exact
Secondary
Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit
Time frame: Day 1, 92 and 169
Population: Safety population included all participants who received any dose of the investigational product. Here, 'N'(number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit | 0 percentage of participants |
| CAT-354 150 mg | Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit | 0 percentage of participants |
| CAT-354 300 mg | Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit | 0 percentage of participants |
| CAT-354 600 mg | Percentage of Participants With Positive Serum Antibodies to CAT-354 at Any Visit | 0 percentage of participants |
Secondary
Serum Concentration for CAT-354
Time frame: Predose on Day 15, 29, 43, 57, 71 and 85; Day 88, 92, 99, 127, and 169
Population: Pharmacokinetic (PK) population included participants who received CAT-354 and had a sufficient number of serum concentration measurements for computing PK parameters. Here, 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentration for CAT-354 | Day 57 (n=46,48,46) | 28.4 microgram per milliliter (mcg/mL) | Standard Deviation 11.3 |
| Placebo | Serum Concentration for CAT-354 | Day 169 (n=47,48,46) | 2.94 microgram per milliliter (mcg/mL) | Standard Deviation 2.23 |
| Placebo | Serum Concentration for CAT-354 | Day 92 (n=45,46,45) | 42.0 microgram per milliliter (mcg/mL) | Standard Deviation 16.3 |
| Placebo | Serum Concentration for CAT-354 | Day 88 (n=46,48,45) | 43.4 microgram per milliliter (mcg/mL) | Standard Deviation 15.8 |
| Placebo | Serum Concentration for CAT-354 | Day 85 (n=45,49,47) | 31.1 microgram per milliliter (mcg/mL) | Standard Deviation 12.5 |
| Placebo | Serum Concentration for CAT-354 | Day 71 (n=46,49,47) | 29.3 microgram per milliliter (mcg/mL) | Standard Deviation 11.9 |
| Placebo | Serum Concentration for CAT-354 | Day 29 (n=45,51,47) | 20.8 microgram per milliliter (mcg/mL) | Standard Deviation 7.2 |
| Placebo | Serum Concentration for CAT-354 | Day 127 (n=47,48,47) | 11.5 microgram per milliliter (mcg/mL) | Standard Deviation 6.02 |
| Placebo | Serum Concentration for CAT-354 | Day 43 (n=46,50,47) | 26.9 microgram per milliliter (mcg/mL) | Standard Deviation 12.7 |
| Placebo | Serum Concentration for CAT-354 | Day 15 (n=46,48,48) | 14.5 microgram per milliliter (mcg/mL) | Standard Deviation 5.57 |
| Placebo | Serum Concentration for CAT-354 | Day 99 (n=46,50,46) | 31.3 microgram per milliliter (mcg/mL) | Standard Deviation 13 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 85 (n=45,49,47) | 62.0 microgram per milliliter (mcg/mL) | Standard Deviation 23.8 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 71 (n=46,49,47) | 61.0 microgram per milliliter (mcg/mL) | Standard Deviation 21.4 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 29 (n=45,51,47) | 40.2 microgram per milliliter (mcg/mL) | Standard Deviation 15 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 15 (n=46,48,48) | 27.8 microgram per milliliter (mcg/mL) | Standard Deviation 10.3 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 43 (n=46,50,47) | 51.0 microgram per milliliter (mcg/mL) | Standard Deviation 16 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 57 (n=46,48,46) | 58.8 microgram per milliliter (mcg/mL) | Standard Deviation 20.2 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 88 (n=46,48,45) | 85.7 microgram per milliliter (mcg/mL) | Standard Deviation 32.7 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 92 (n=45,46,45) | 86.8 microgram per milliliter (mcg/mL) | Standard Deviation 33.1 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 99 (n=46,50,46) | 69.3 microgram per milliliter (mcg/mL) | Standard Deviation 27.2 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 127 (n=47,48,47) | 22.9 microgram per milliliter (mcg/mL) | Standard Deviation 12 |
| CAT-354 150 mg | Serum Concentration for CAT-354 | Day 169 (n=47,48,46) | 5.87 microgram per milliliter (mcg/mL) | Standard Deviation 3.69 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 127 (n=47,48,47) | 43.7 microgram per milliliter (mcg/mL) | Standard Deviation 20.5 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 92 (n=45,46,45) | 156 microgram per milliliter (mcg/mL) | Standard Deviation 46.6 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 43 (n=46,50,47) | 98.5 microgram per milliliter (mcg/mL) | Standard Deviation 33.4 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 15 (n=46,48,48) | 56.4 microgram per milliliter (mcg/mL) | Standard Deviation 16 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 99 (n=46,50,46) | 125 microgram per milliliter (mcg/mL) | Standard Deviation 41.9 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 29 (n=45,51,47) | 81.9 microgram per milliliter (mcg/mL) | Standard Deviation 23.5 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 85 (n=45,49,47) | 120 microgram per milliliter (mcg/mL) | Standard Deviation 44.5 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 71 (n=46,49,47) | 112 microgram per milliliter (mcg/mL) | Standard Deviation 41.2 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 169 (n=47,48,46) | 10.1 microgram per milliliter (mcg/mL) | Standard Deviation 6.71 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 88 (n=46,48,45) | 157 microgram per milliliter (mcg/mL) | Standard Deviation 56.5 |
| CAT-354 300 mg | Serum Concentration for CAT-354 | Day 57 (n=46,48,46) | 108 microgram per milliliter (mcg/mL) | Standard Deviation 35.8 |
Secondary
Time to First Moderate or Severe Asthma Exacerbation
Time to first moderate or severe asthma exacerbation was defined as time to first observed progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) or a reduction of \>=20% in PEF or FEV1 from baseline that did not resolve after the initiation of rescue medications and resulted in an administration of systemic corticosteroids by the investigator or health care provider.
Time frame: Day 1 to Day 92 and Day 169
Population: Evaluable population included all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 92 | 89.67 days | Standard Error 1.56 |
| Placebo | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 169 | 162.24 days | Standard Error 3.79 |
| CAT-354 150 mg | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 169 | 163.50 days | Standard Error 3.24 |
| CAT-354 150 mg | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 92 | 90.43 days | Standard Error 1.32 |
| CAT-354 300 mg | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 92 | 88.16 days | Standard Error 2.12 |
| CAT-354 300 mg | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 169 | 158.29 days | Standard Error 4.41 |
| CAT-354 600 mg | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 92 | 89.94 days | Standard Error 1.36 |
| CAT-354 600 mg | Time to First Moderate or Severe Asthma Exacerbation | Day 1 to 169 | 161.21 days | Standard Error 3.71 |
p-value: 0.546Log Rank
p-value: 0.534Log Rank
p-value: 0.847Log Rank
p-value: 0.987Log Rank
p-value: 0.992Log Rank
p-value: 0.688Log Rank
Secondary
Time to First Observed Asthma Control
Time to first asthma control was defined as the number of days from Study Day 1 to the post-baseline ACQ score measurement time point when greater than or equal to (\>=) 0.5 reduction from baseline in mean ACQ score was first observed. Time to first asthma control was analyzed from Day 1 through Day 92 and up to entire study duration through Day 169. The ACQ score is a participant-reported questionnaire to assess the asthma control with 6 items assessing night-time waking, symptoms on waking, activity limitation, shortness of breath, wheeze, and rescue short-acting beta agonist use. Each item was rated on a 7-point Likert scale ranging from 0 (no impairment) to 6 (maximum impairment). Overall ACQ score is the mean of the 6 item scores with a score range of 0 (well controlled) to 6 (extremely poor controlled).
Time frame: Day 1 to Day 92 and Day 169
Population: Evaluable population = all participants who received at least 4 doses of investigational product or received at least 1 dose but discontinued treatment due to safety reasons. Since, \>50% participants for each arm achieved improvement through Day 92; the median time-to-first observed achievement is identical for data through Day 92 and Day 169.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time to First Observed Asthma Control | Day 1 to 92 | 25.5 days | 95% Confidence Interval 5.5 |
| Placebo | Time to First Observed Asthma Control | Day 1 to 169 | 25.5 days | 95% Confidence Interval 9.97 |
| CAT-354 150 mg | Time to First Observed Asthma Control | Day 1 to 169 | 22.0 days | 95% Confidence Interval 8.89 |
| CAT-354 150 mg | Time to First Observed Asthma Control | Day 1 to 92 | 22.0 days | 95% Confidence Interval 5.21 |
| CAT-354 300 mg | Time to First Observed Asthma Control | Day 1 to 92 | 15.0 days | 95% Confidence Interval 4.54 |
| CAT-354 300 mg | Time to First Observed Asthma Control | Day 1 to 169 | 15.0 days | 95% Confidence Interval 7.65 |
| CAT-354 600 mg | Time to First Observed Asthma Control | Day 1 to 92 | 15.0 days | 95% Confidence Interval 4.56 |
| CAT-354 600 mg | Time to First Observed Asthma Control | Day 1 to 169 | 15.0 days | 95% Confidence Interval 8.07 |
Comparison: P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.p-value: 0.4686Log Rank
Comparison: P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.p-value: 0.317Log Rank
Comparison: P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.p-value: 0.1664Log Rank
Comparison: P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.p-value: 0.3234Log Rank
Comparison: P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.p-value: 0.3133Log Rank
Comparison: P-value were calculated with log-rank test, which was constructed by computing the observed and expected number of events (defined as achieving improvement from baseline in mean ACQ-6 score \>= 0.5) at each observed event time and added to obtain an overall summary across all-time points where there was an event. Number of events was different for data through Day 92 comparing with data through Day 169. Therefore, the p-values were different for data through Day 92 and Day 169.p-value: 0.2108Log Rank