Asthma, Common Cold, Picornavirus Infection, Rhinovirus
Conditions
Brief summary
This is a randomized, multi-center, double-blind, placebo-controlled study evaluating the efficacy of pleconaril nasal spray in preventing asthma exacerbation and common cold symptoms in asthmatic participants exposed to picornavirus respiratory infections. Participants will be assigned treatment with pleconaril or placebo nasal spray for 7 days (14 doses). Participants will be followed for an additional 14 days.
Interventions
DRUGPleconaril
Pleconaril nasal suspension is supplied in a bottle containing 120 actuations. Each actuation contains 1.5 mg of pleconaril.
DRUGPlacebo to Pleconaril
Placebo nasal suspension
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Must be ≥6 to ≤65 years of age, of either sex, and of any race, with a diagnosis of asthma at least 2 years prior to the Screening Visit. * Must have a history of two or more upper respiratory infection-induced asthma exacerbations in the past 24 months. * For participants 6 to 17 years of age, exacerbations for the purpose of the inclusion criteria, will be defined as: * An increase of four or more puffs of a short-acting beta-agonist (SABA) per day for at least 3 consecutive days, or * An increase of two or more nebulizations of a SABA per day for at least 3 consecutive days, or * Documentation of morning (AM) peak flow drops \>20% per day for at least 2 consecutive days, or * Documentation of AM peak flow drops of ≥50% for at least 1 day. * Must have been on a stable dose of any asthma medication (including immunotherapy) for at least 1 month prior to the Screening Visit. * Must have a pre-bronchodilator FEV1 ≥50% predicted at the Screening Visit, when all prohibited medications have been withheld for the specified interval. * If a reversibility test has not been performed within the previous 24 months, a participant, ≥17 years of age, must demonstrate an increase in absolute FEV1 of ≥12%, with an absolute volume increase of at least 200 mL. A participant \<17 years of age, must demonstrate an increase in absolute FEV1 ≥12%. * Must cohabit with at least one other person (family member, roommate). * A participant (or the participant's legal representation) must be willing to give written informed consent and be able to adhere to dose and visit schedules. * Must be free of any clinically significant disease, other than asthma, which would interfere with study evaluation. * Must be in general good health, as confirmed by routine clinical and laboratory testing. All laboratory tests (Complete Blood Count, blood chemistries, and urinalysis) and elctrocardiograms must be within normal limits or clinically acceptable to the investigator/sponsor. * Female of childbearing potential must be using a medically acceptable, adequate form of birth control.
Exclusion criteria
* Had an upper or lower respiratory illness or exhibits signs and/or symptoms of a respiratory illness in the 4 weeks prior to the Screening Visit. * Received any treatment more recently than the indicated washout period prior to Screening or who must continue to receive treatment that is prohibited. * Smoker or ex-smoker and has smoked within the previous 5 years of Screening or has had a cumulative smoking history \>10 pack years. * Allergy/sensitivity to the study drug or its excipients. * Female who is breast-feeding, pregnant, or intends to become pregnant. * Used any investigational drugs within 30 days of Screening. * Participating in any other clinical study. * Part of the staff personnel directly involved with this study. * Family member of the investigational study staff.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Rhinovirus PCR-Positive Colds | From time of exposure to index case to end of Follow-up Period (21 days) | The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization. |
| Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR | From time of exposure to index case to end of Follow-up Period (21 days) | Asthma exacerbation was defined as a participant having one of the following: 1. 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. 2. Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Baseline through the Final Visit (Day 21) | PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model. |
| LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Baseline through the Final Visit (Day 21) | PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model. |
| LS Mean Change From Baseline in Total Cold Symptom Score | Baseline through the Final Visit (Day 21) | Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model. |
| LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Baseline through the Final Visit (Day 21) | The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model. |
| LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Baseline through the Final Visit (Day 21) | SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model. |
| LS Mean Change From Baseline in Asthma-Related Sleep Interference | Baseline through the Final Visit (Day 21) | Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model. |
| LS Mean Change From Baseline in Total Asthma Symptom Score | Baseline through the Final Visit (Day 21) | Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model. |
| LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline through the Final Visit (Day 21) | FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model. |
Participant flow
Pre-assignment details
All enrolled participants were screened. After the screening visit and before randomization, participants received weekly phone calls and revisited the site once per month during a Pre-exposure Period until exposed to a household member with a cold (index case).
Participants by arm
| Arm | Count |
|---|---|
| Pleconaril Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses. | 154 |
| Placebo Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses. | 157 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Treatment Period | Adverse Event | 0 | 3 | 1 |
| Treatment Period | Did not meet protocol eligibility | 0 | 1 | 1 |
| Treatment Period | Lost to Follow-up | 0 | 1 | 0 |
| Treatment Period | Noncompliance with protocol | 0 | 3 | 2 |
| Treatment Period | Withdrawal by Subject | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Pleconaril | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 29.4 years STANDARD_DEVIATION 16.7 | 28.7 years STANDARD_DEVIATION 17.3 | 29.1 years STANDARD_DEVIATION 17 |
| Sex: Female, Male Female | 85 Participants | 97 Participants | 182 Participants |
| Sex: Female, Male Male | 69 Participants | 60 Participants | 129 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 154 | 9 / 157 |
| serious Total, serious adverse events | 0 / 154 | 0 / 157 |
Outcome results
Primary
Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR
Asthma exacerbation was defined as a participant having one of the following: 1. 0.5 point or more increase in the Asthma Control Questionnaire (ACQ) from Baseline at Day 7. The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. 2. Any change to asthma treatment as prescribed by a physician, unscheduled contact (either office visit or phone contact where medication was changed for asthma symptoms), emergency room visit, or hospitalization. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Time frame: From time of exposure to index case to end of Follow-up Period (21 days)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine exacerbation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pleconaril | Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR | 1.3 percentage of participants |
| Placebo | Percentage of Participants With Asthma Exacerbations Together With Rhinovirus-Positive PCR | 2.5 percentage of participants |
p-value: 0.425Cochran-Mantel-Haenszel
Primary
Percentage of Participants With Rhinovirus PCR-Positive Colds
The common cold was defined as moderate or severe rhinorrhea and at least one other cold symptom of moderate to severe intensity for at least 1 day, together with rhinovirus-positive polymerase chain reaction (PCR), after a participant had temporal exposure to an index case. PCR+ was defined as positive or equivocal outcome of the picornavirus test any time after randomization.
Time frame: From time of exposure to index case to end of Follow-up Period (21 days)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some follow-up information. Randomized participants with no follow-up information were included in the number of participants assigned to each treatment group to determine rhinovirus cold.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pleconaril | Percentage of Participants With Rhinovirus PCR-Positive Colds | 2.6 percentage of participants |
| Placebo | Percentage of Participants With Rhinovirus PCR-Positive Colds | 2.5 percentage of participants |
p-value: 0.973Cochran-Mantel-Haenszel
Secondary
LS Mean Change From Baseline in Asthma-Related Sleep Interference
Participants entered their asthma-related changes in sleep into an e-diary once daily (in the morning) beginning at the Screening Visit through completion of the study. Changes from Baseline in asthma-related sleep interference were determined using the following question: How did cold and asthma symptoms interfere with your sleep? The question was scored as follows: 0 = None, no interference with sleep at all, 1 = Mild, not annoying or troublesome, adequate amount of sleep, 2 = Moderate, interfered somewhat with sleep, woke up a few times, average sleep, 3 = Severe, substantially interfered with sleep, poor sleep. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some sleep follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 3 (n=140, n=152) | 0.02 units on a scale | Standard Deviation 0.39 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Week 2 (n=142, n=152) | -0.05 units on a scale | Standard Deviation 0.33 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 11 (n=135, n=148) | -0.03 units on a scale | Standard Deviation 0.4 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 12 (n=135, n=146) | 0.01 units on a scale | Standard Deviation 0.39 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 13 (n=134, n=146) | -0.04 units on a scale | Standard Deviation 0.36 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 14 (n=133, n=146) | -0.04 units on a scale | Standard Deviation 0.38 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 15 (n=132, n=142) | -0.01 units on a scale | Standard Deviation 0.46 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 16 (n=129, n=138) | -0.03 units on a scale | Standard Deviation 0.39 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 17 (n=127, n=141) | -0.01 units on a scale | Standard Deviation 0.36 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 18 (n=131, n=145) | -0.03 units on a scale | Standard Deviation 0.34 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 19 (n=129, n=144) | -0.03 units on a scale | Standard Deviation 0.38 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 20 (n=123, n=133) | -0.06 units on a scale | Standard Deviation 0.39 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 21 (n=107, n=121) | -0.04 units on a scale | Standard Deviation 0.35 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Final Day (n=146, n=153) | -0.02 units on a scale | Standard Deviation 0.43 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Week 1 (n=145, n=153) | 0.00 units on a scale | Standard Deviation 0.27 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Week 3 (n=138, n=150) | -0.02 units on a scale | Standard Deviation 0.35 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Final Week (n=146, n=153) | -0.03 units on a scale | Standard Deviation 0.36 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Baseline (n=146, n=153) | 0.12 units on a scale | Standard Deviation 0.29 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 2 (n=141, n=152) | 0.06 units on a scale | Standard Deviation 0.34 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 4 (n=141, n=151) | 0.00 units on a scale | Standard Deviation 0.37 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 5 (n=138, n=152) | -0.01 units on a scale | Standard Deviation 0.37 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 6 (n=135, n=151) | -0.02 units on a scale | Standard Deviation 0.38 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 7 (n=136, n=149) | -0.05 units on a scale | Standard Deviation 0.4 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 8 (n=137, n=147) | -0.06 units on a scale | Standard Deviation 0.37 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 9 (n=136, n=148) | -0.04 units on a scale | Standard Deviation 0.39 |
| Pleconaril | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 10 (n=136, n=149) | -0.02 units on a scale | Standard Deviation 0.41 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 2 (n=141, n=152) | 0.01 units on a scale | Standard Deviation 0.34 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 9 (n=136, n=148) | -0.00 units on a scale | Standard Deviation 0.39 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Week 1 (n=145, n=153) | 0.03 units on a scale | Standard Deviation 0.27 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 21 (n=107, n=121) | 0.05 units on a scale | Standard Deviation 0.35 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Final Week (n=146, n=153) | -0.00 units on a scale | Standard Deviation 0.36 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 10 (n=136, n=149) | -0.02 units on a scale | Standard Deviation 0.41 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 4 (n=141, n=151) | 0.03 units on a scale | Standard Deviation 0.37 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 11 (n=135, n=148) | -0.02 units on a scale | Standard Deviation 0.4 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Final Day (n=146, n=153) | 0.04 units on a scale | Standard Deviation 0.43 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 12 (n=135, n=146) | -0.02 units on a scale | Standard Deviation 0.39 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 3 (n=140, n=152) | 0.04 units on a scale | Standard Deviation 0.39 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 13 (n=134, n=146) | -0.01 units on a scale | Standard Deviation 0.36 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Week 2 (n=142, n=152) | 0.00 units on a scale | Standard Deviation 0.33 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 14 (n=133, n=146) | -0.01 units on a scale | Standard Deviation 0.38 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 6 (n=135, n=151) | 0.05 units on a scale | Standard Deviation 0.38 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 15 (n=132, n=142) | 0.04 units on a scale | Standard Deviation 0.46 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Week 3 (n=138, n=150) | -0.01 units on a scale | Standard Deviation 0.35 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 16 (n=129, n=138) | 0.01 units on a scale | Standard Deviation 0.39 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 8 (n=137, n=147) | 0.03 units on a scale | Standard Deviation 0.37 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 17 (n=127, n=141) | -0.03 units on a scale | Standard Deviation 0.36 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 5 (n=138, n=152) | 0.02 units on a scale | Standard Deviation 0.37 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 18 (n=131, n=145) | -0.05 units on a scale | Standard Deviation 0.34 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Baseline (n=146, n=153) | 0.07 units on a scale | Standard Deviation 0.29 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 19 (n=129, n=144) | -0.03 units on a scale | Standard Deviation 0.38 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 7 (n=136, n=149) | 0.05 units on a scale | Standard Deviation 0.4 |
| Placebo | LS Mean Change From Baseline in Asthma-Related Sleep Interference | Change From BL to Day 20 (n=123, n=133) | 0.02 units on a scale | Standard Deviation 0.39 |
Secondary
LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Pooled SDs and LS means were calculated based on an ANOVA model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some FEV1 follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline (n=152, n=156) | 2.335 liters | Standard Deviation 0.728 |
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 2 (n=111, n=115) | -0.091 liters | Standard Deviation 0.267 |
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 4 (n=97, n=102) | -0.059 liters | Standard Deviation 0.273 |
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 8 (n=132, n=135) | -0.070 liters | Standard Deviation 0.274 |
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 10 (n=116, n=120) | -0.090 liters | Standard Deviation 0.271 |
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 14 (n=140, n=139) | -0.063 liters | Standard Deviation 0.266 |
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 21 (n=141, n=146) | -0.080 liters | Standard Deviation 0.287 |
| Pleconaril | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Final Visit (n=152, n=156) | -0.076 liters | Standard Deviation 0.291 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Final Visit (n=152, n=156) | -0.141 liters | Standard Deviation 0.291 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Baseline (n=152, n=156) | 2.214 liters | Standard Deviation 0.728 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 10 (n=116, n=120) | -0.109 liters | Standard Deviation 0.271 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 2 (n=111, n=115) | -0.100 liters | Standard Deviation 0.267 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 21 (n=141, n=146) | -0.133 liters | Standard Deviation 0.287 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 4 (n=97, n=102) | -0.141 liters | Standard Deviation 0.273 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 14 (n=140, n=139) | -0.090 liters | Standard Deviation 0.266 |
| Placebo | LS Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | Change From BL to Day 8 (n=132, n=135) | -0.121 liters | Standard Deviation 0.274 |
Secondary
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM
PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 7 (n=102, n=112) | 2.5 L/min | Standard Deviation 57.5 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 6 (n=104, n=114) | 0.2 L/min | Standard Deviation 60.3 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Baseline (n=124, n=136) | 306.2 L/min | Standard Deviation 96.8 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 2 (n=108, n=123) | -0.1 L/min | Standard Deviation 55.4 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 4 (n=103, n=118) | 5.1 L/min | Standard Deviation 59.1 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 5 (n=96, n=122) | 0.2 L/min | Standard Deviation 45.9 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 3 (n=103, n=120) | 9.9 L/min | Standard Deviation 57.7 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 8 (n=102, n=116) | -0.6 L/min | Standard Deviation 47 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 9 (n=105, n=114) | 13.6 L/min | Standard Deviation 63.9 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 10 (n=90, n=102) | 7.7 L/min | Standard Deviation 54.6 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 11 (n=95, n=108) | -3.9 L/min | Standard Deviation 51.4 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 12 (n=94, n=102) | 3.2 L/min | Standard Deviation 77.8 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 13 (n=88, n=97) | 4.7 L/min | Standard Deviation 55.3 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 14 (n=90, n=103) | 3.4 L/min | Standard Deviation 69.3 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 15 (n=91, n=107) | -3.2 L/min | Standard Deviation 76.8 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 16 (n=92, n=101) | 4.4 L/min | Standard Deviation 49.5 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 17 (n=74, n=93) | 6.0 L/min | Standard Deviation 51 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 18 (n=80, n=98) | 0.7 L/min | Standard Deviation 57.9 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 19 (n=81, n=102) | 1.2 L/min | Standard Deviation 62.7 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 20 (n=76, n=88) | 10.2 L/min | Standard Deviation 58 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 21 (n=62, n=85) | 10.5 L/min | Standard Deviation 49.1 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Final Day (n=124, n=136) | 4.6 L/min | Standard Deviation 57.8 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Week 1 (n=122, n=136) | -0.7 L/min | Standard Deviation 39.2 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Week 2 (n=119, n=134) | 1.4 L/min | Standard Deviation 45.9 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Week 3 (n=109, n=127) | 5.2 L/min | Standard Deviation 48.7 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Final Week (n=124, n=136) | 2.3 L/min | Standard Deviation 49.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 20 (n=76, n=88) | 10.4 L/min | Standard Deviation 58 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 3 (n=103, n=120) | 6.1 L/min | Standard Deviation 57.7 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 14 (n=90, n=103) | 23.5 L/min | Standard Deviation 69.3 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 6 (n=104, n=114) | 2.5 L/min | Standard Deviation 60.3 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Week 3 (n=109, n=127) | -1.1 L/min | Standard Deviation 48.7 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Baseline (n=124, n=136) | 284.0 L/min | Standard Deviation 96.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 15 (n=91, n=107) | 3.9 L/min | Standard Deviation 76.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 2 (n=108, n=123) | -1.9 L/min | Standard Deviation 55.4 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 21 (n=62, n=85) | -1.4 L/min | Standard Deviation 49.1 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 4 (n=103, n=118) | -1.1 L/min | Standard Deviation 59.1 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 16 (n=92, n=101) | -1.7 L/min | Standard Deviation 49.5 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 5 (n=96, n=122) | -3.4 L/min | Standard Deviation 45.9 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Week 2 (n=119, n=134) | 4.5 L/min | Standard Deviation 45.9 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 7 (n=102, n=112) | -4.0 L/min | Standard Deviation 57.5 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 17 (n=74, n=93) | -6.9 L/min | Standard Deviation 51 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 8 (n=102, n=116) | -0.9 L/min | Standard Deviation 47 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Final Day (n=124, n=136) | -5.2 L/min | Standard Deviation 57.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 9 (n=105, n=114) | 8.1 L/min | Standard Deviation 63.9 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 18 (n=80, n=98) | 10.8 L/min | Standard Deviation 57.9 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 10 (n=90, n=102) | 0.6 L/min | Standard Deviation 54.6 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Final Week (n=124, n=136) | -3.8 L/min | Standard Deviation 49.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 11 (n=95, n=108) | -0.6 L/min | Standard Deviation 51.4 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 19 (n=81, n=102) | 4.1 L/min | Standard Deviation 62.7 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 12 (n=94, n=102) | 11.5 L/min | Standard Deviation 77.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Week 1 (n=122, n=136) | -2.2 L/min | Standard Deviation 39.2 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in AM | Change From BL to Day 13 (n=88, n=97) | 7.7 L/min | Standard Deviation 55.3 |
Secondary
LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM
PEF is a person's maximum speed of expiration as measured with a peak flow meter and was measured twice daily in the morning (AM) and evening (PM). Pooled SDs and LS means were calculated based on an ANOVA model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some PEF follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Final Week (n=119, n=128) | 3.1 L/min | Standard Deviation 53.6 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Baseline (n=119, n=128) | 310.9 L/min | Standard Deviation 93.6 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 1 (n=93, n=105) | 0.4 L/min | Standard Deviation 48.2 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 2 (n=102, n=115) | 2.0 L/min | Standard Deviation 57.7 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 3 (n=98, n=112) | 2.3 L/min | Standard Deviation 45.6 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 4 (n=98, n=108) | 8.2 L/min | Standard Deviation 54.2 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 5 (n=105, n=109) | -3.7 L/min | Standard Deviation 57 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 6 (n=98, n=108) | -3.5 L/min | Standard Deviation 46.3 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 7 (n=95, n=106) | 10.0 L/min | Standard Deviation 59.1 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 8 (n=94, n=106) | 11.2 L/min | Standard Deviation 76.7 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 9 (n=91, n=103) | 3.5 L/min | Standard Deviation 52.6 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 10 (n=91, n=99) | 9.2 L/min | Standard Deviation 58.9 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 11 (n=83, n=97) | -3.0 L/min | Standard Deviation 62.7 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 12 (n=82, n=90) | -2.6 L/min | Standard Deviation 71.5 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 13 (n=85, n=98) | 9.3 L/min | Standard Deviation 56.4 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 14 (n=80, n=98) | 2.4 L/min | Standard Deviation 48.6 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 16 (n=82, n=84) | -6.8 L/min | Standard Deviation 49.4 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 17 (n=81, n=93) | -1.1 L/min | Standard Deviation 54.8 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 18 (n=84, n=97) | 3.2 L/min | Standard Deviation 59.4 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 19 (n=80, n=93) | -1.0 L/min | Standard Deviation 55.8 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 20 (n=78, n=80) | 16.2 L/min | Standard Deviation 64.8 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 21 (n=47, n=63) | -7.5 L/min | Standard Deviation 96.1 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Final Day (n=119, n=128) | 10.4 L/min | Standard Deviation 81.1 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Week 1 (n=116, n=127) | 2.5 L/min | Standard Deviation 38.4 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Week 2 (n=113, n=124) | 3.4 L/min | Standard Deviation 49.2 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Week 3 (n=103, n=117) | -3.5 L/min | Standard Deviation 49.5 |
| Pleconaril | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 15 (n=88, n=89) | -0.2 L/min | Standard Deviation 49.7 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 19 (n=80, n=93) | 12.3 L/min | Standard Deviation 55.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 15 (n=88, n=89) | -9.0 L/min | Standard Deviation 49.7 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Final Week (n=119, n=128) | 8.1 L/min | Standard Deviation 53.6 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 12 (n=82, n=90) | 8.9 L/min | Standard Deviation 71.5 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Baseline (n=119, n=128) | 293.4 L/min | Standard Deviation 93.6 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Week 2 (n=113, n=124) | 6.0 L/min | Standard Deviation 49.2 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 1 (n=93, n=105) | 1.0 L/min | Standard Deviation 48.2 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 13 (n=85, n=98) | 8.1 L/min | Standard Deviation 56.4 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 2 (n=102, n=115) | 0.4 L/min | Standard Deviation 57.7 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 20 (n=78, n=80) | 12.6 L/min | Standard Deviation 64.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 3 (n=98, n=112) | -14.7 L/min | Standard Deviation 45.6 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 14 (n=80, n=98) | 1.7 L/min | Standard Deviation 48.6 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 4 (n=98, n=108) | 3.1 L/min | Standard Deviation 54.2 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Week 1 (n=116, n=127) | -2.0 L/min | Standard Deviation 38.4 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 5 (n=105, n=109) | 1.6 L/min | Standard Deviation 57 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 16 (n=82, n=84) | -6.1 L/min | Standard Deviation 49.4 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 6 (n=98, n=108) | -9.8 L/min | Standard Deviation 46.3 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 21 (n=47, n=63) | 12.3 L/min | Standard Deviation 96.1 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 7 (n=95, n=106) | -1.6 L/min | Standard Deviation 59.1 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 17 (n=81, n=93) | -1.1 L/min | Standard Deviation 54.8 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 8 (n=94, n=106) | 20.2 L/min | Standard Deviation 76.7 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Week 3 (n=103, n=117) | 3.5 L/min | Standard Deviation 49.5 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 9 (n=91, n=103) | -3.4 L/min | Standard Deviation 52.6 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 18 (n=84, n=97) | 3.7 L/min | Standard Deviation 59.4 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 10 (n=91, n=99) | 9.1 L/min | Standard Deviation 58.9 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Final Day (n=119, n=128) | 14.7 L/min | Standard Deviation 81.1 |
| Placebo | LS Mean Change From Baseline in Peak Expiratory Flow (PEF) in PM | Change From BL to Day 11 (n=83, n=97) | 1.0 L/min | Standard Deviation 62.7 |
Secondary
LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage
SABAs such as albuterol were permitted during the study as rescue medication and required a 6-hour washout prior to each visit. Participants entered their asthma medication use into an e-diary twice daily beginning at the Screening Visit through completion of the study. The Baseline for diary symptoms was the average of the last seven assessments prior to Randomization. Pooled SDs and LS means were calculated based on an ANOVA model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some SABA follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 20 (n=108, n=118) | 0.19 number of puffs of SABA | Standard Deviation 2.15 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 14 (n=131, n=140) | 0.20 number of puffs of SABA | Standard Deviation 3.08 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 15 (n=126, n=137) | 0.40 number of puffs of SABA | Standard Deviation 4.12 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Baseline (n=143, n=148) | 0.99 number of puffs of SABA | Standard Deviation 2.43 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 1 (n=131, n=138) | 0.15 number of puffs of SABA | Standard Deviation 2.37 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 2 (n=137, n=146) | 0.19 number of puffs of SABA | Standard Deviation 3.75 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 3 (n=135, n=146) | 0.29 number of puffs of SABA | Standard Deviation 3.17 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 4 (n=137, n=147) | 0.17 number of puffs of SABA | Standard Deviation 2.01 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 5 (n=135, n=147) | 0.04 number of puffs of SABA | Standard Deviation 1.86 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 6 (n=131, n=146) | -0.05 number of puffs of SABA | Standard Deviation 1.45 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 7 (n=135, n=144) | 0.17 number of puffs of SABA | Standard Deviation 1.88 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 8 (n=129, n=141) | -0.09 number of puffs of SABA | Standard Deviation 1.63 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 9 (n=131, n=142) | -0.24 number of puffs of SABA | Standard Deviation 1.76 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 10 (n=130, n=144) | -0.26 number of puffs of SABA | Standard Deviation 1.76 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 11 (n=128, n=141) | -0.13 number of puffs of SABA | Standard Deviation 1.92 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 12 (n=129, n=139) | 0.01 number of puffs of SABA | Standard Deviation 2.38 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 13 (n=130, n=139) | 0.03 number of puffs of SABA | Standard Deviation 3.05 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 16 (n=126, n=136) | 0.32 number of puffs of SABA | Standard Deviation 2.45 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 17 (n=127, n=138) | -0.00 number of puffs of SABA | Standard Deviation 2.13 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 18 (n=130, n=139) | -0.30 number of puffs of SABA | Standard Deviation 2.07 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 19 (n=121, n=133) | 0.10 number of puffs of SABA | Standard Deviation 2.25 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 21 (n=78, n=83) | 0.25 number of puffs of SABA | Standard Deviation 1.76 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Final Day (n=143, n=148) | -0.05 number of puffs of SABA | Standard Deviation 2.11 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Week 1 (n=142, n=148) | 0.15 number of puffs of SABA | Standard Deviation 2.1 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Week 2 (n=139, n=146) | 0.06 number of puffs of SABA | Standard Deviation 2.88 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Week 3 (n=135, n=145) | 0.08 number of puffs of SABA | Standard Deviation 1.93 |
| Pleconaril | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Final Week (n=143, n=148) | 0.09 number of puffs of SABA | Standard Deviation 1.9 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Baseline (n=143, n=148) | 0.81 number of puffs of SABA | Standard Deviation 2.43 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 11 (n=128, n=141) | -0.05 number of puffs of SABA | Standard Deviation 1.92 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 14 (n=131, n=140) | -0.07 number of puffs of SABA | Standard Deviation 3.08 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 20 (n=108, n=118) | 0.39 number of puffs of SABA | Standard Deviation 2.15 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 15 (n=126, n=137) | -0.11 number of puffs of SABA | Standard Deviation 4.12 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Week 3 (n=135, n=145) | 0.22 number of puffs of SABA | Standard Deviation 1.93 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 12 (n=129, n=139) | -0.12 number of puffs of SABA | Standard Deviation 2.38 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Week 1 (n=142, n=148) | 0.08 number of puffs of SABA | Standard Deviation 2.1 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 1 (n=131, n=138) | -0.15 number of puffs of SABA | Standard Deviation 2.37 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 13 (n=130, n=139) | -0.14 number of puffs of SABA | Standard Deviation 3.05 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 2 (n=137, n=146) | -0.16 number of puffs of SABA | Standard Deviation 3.75 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 21 (n=78, n=83) | 0.11 number of puffs of SABA | Standard Deviation 1.76 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 3 (n=135, n=146) | 0.03 number of puffs of SABA | Standard Deviation 3.17 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 16 (n=126, n=136) | 0.26 number of puffs of SABA | Standard Deviation 2.45 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 4 (n=137, n=147) | 0.23 number of puffs of SABA | Standard Deviation 2.01 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Final Week (n=143, n=148) | 0.21 number of puffs of SABA | Standard Deviation 1.9 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 5 (n=135, n=147) | 0.27 number of puffs of SABA | Standard Deviation 1.86 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 17 (n=127, n=138) | 0.01 number of puffs of SABA | Standard Deviation 2.13 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 6 (n=131, n=146) | 0.12 number of puffs of SABA | Standard Deviation 1.45 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Final Day (n=143, n=148) | 0.12 number of puffs of SABA | Standard Deviation 2.11 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 7 (n=135, n=144) | 0.19 number of puffs of SABA | Standard Deviation 1.88 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 18 (n=130, n=139) | 0.07 number of puffs of SABA | Standard Deviation 2.07 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 8 (n=129, n=141) | 0.06 number of puffs of SABA | Standard Deviation 1.63 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Week 2 (n=139, n=146) | -0.12 number of puffs of SABA | Standard Deviation 2.88 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 9 (n=131, n=142) | -0.14 number of puffs of SABA | Standard Deviation 1.76 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 19 (n=121, n=133) | 0.11 number of puffs of SABA | Standard Deviation 2.25 |
| Placebo | LS Mean Change From Baseline in Short-acting Beta-Agonist (SABA) Rescue Medication Usage | Change From BL to Day 10 (n=130, n=144) | -0.14 number of puffs of SABA | Standard Deviation 1.76 |
Secondary
LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ)
The ACQ is a validated instrument containing 7 questions to assess asthma control which incorporates symptoms, beta-agonist use, and spirometry. Participants recall their experiences during the previous 7 days and respond to each question using a 7-point scale. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore ranges between 0 (well controlled) and 6 (extremely poorly controlled). The ACQ completed on the day of exposure was the Baseline ACQ. Pooled standard deviations (SDs) and least square (LS) means were calculated based on an analysis of variates (ANOVA) model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some ACQ follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Day 8 (n=120, n=124) | -0.11 units on a scale | Standard Deviation 0.52 |
| Pleconaril | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Day 21 (n=89, n=96) | -0.12 units on a scale | Standard Deviation 0.56 |
| Pleconaril | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Day 14 (n=94, n=96) | -0.09 units on a scale | Standard Deviation 0.58 |
| Pleconaril | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Final Visit (n=126, n=127) | -0.09 units on a scale | Standard Deviation 0.56 |
| Pleconaril | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Baseline (n=126, n=127) | 0.86 units on a scale | Standard Deviation 0.72 |
| Placebo | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Final Visit (n=126, n=127) | -0.00 units on a scale | Standard Deviation 0.56 |
| Placebo | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Baseline (n=126, n=127) | 0.87 units on a scale | Standard Deviation 0.72 |
| Placebo | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Day 8 (n=120, n=124) | -0.06 units on a scale | Standard Deviation 0.52 |
| Placebo | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Day 14 (n=94, n=96) | -0.15 units on a scale | Standard Deviation 0.58 |
| Placebo | LS Mean Change From Baseline in the Asthma Control Questionnaire (ACQ) | Change From BL to Day 21 (n=89, n=96) | -0.02 units on a scale | Standard Deviation 0.56 |
Secondary
LS Mean Change From Baseline in Total Asthma Symptom Score
Participants entered their asthma symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total asthma symptom score was the sum of 3 scores for wheeze, cough, and dyspnea. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 9, with increasing scores reflecting more severe asthma. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some asthma symptom score follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 2 (n=143, n=152) | 0.05 units on a scale | Standard Deviation 0.6 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 4 (n=142, n=152) | -0.04 units on a scale | Standard Deviation 0.77 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 13 (n=136, n=146) | -0.06 units on a scale | Standard Deviation 0.92 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 14 (n=138, n=146) | -0.07 units on a scale | Standard Deviation 0.85 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 21 (n=108, n=121) | -0.10 units on a scale | Standard Deviation 0.93 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Baseline (n=147, n=153) | 0.67 units on a scale | Standard Deviation 1.03 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 1 (n=135, n=143) | 0.02 units on a scale | Standard Deviation 0.71 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 3 (n=141, n=152) | 0.04 units on a scale | Standard Deviation 0.65 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 5 (n=140, n=152) | -0.10 units on a scale | Standard Deviation 0.81 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 6 (n=136, n=152) | -0.10 units on a scale | Standard Deviation 0.88 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 7 (n=139, n=150) | -0.07 units on a scale | Standard Deviation 0.9 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 8 (n=139, n=149) | -0.07 units on a scale | Standard Deviation 0.95 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 9 (n=138, n=150) | -0.07 units on a scale | Standard Deviation 0.88 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 10 (n=139, n=150) | -0.01 units on a scale | Standard Deviation 0.96 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 11 (n=137, n=149) | -0.05 units on a scale | Standard Deviation 1.02 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 12 (n=137, n=148) | -0.02 units on a scale | Standard Deviation 1.02 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 15 (n=135, n=144) | -0.11 units on a scale | Standard Deviation 0.86 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 16 (n=132, n=144) | -0.16 units on a scale | Standard Deviation 0.93 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 17 (n=133, n=145) | -0.18 units on a scale | Standard Deviation 0.84 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 18 (n=137, n=146) | -0.14 units on a scale | Standard Deviation 0.91 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 19 (n=132, n=145) | -0.14 units on a scale | Standard Deviation 1.03 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 20 (n=126, n=136) | -0.15 units on a scale | Standard Deviation 0.97 |
| Pleconaril | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Final Day (n=147, n=153) | -0.09 units on a scale | Standard Deviation 0.94 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 16 (n=132, n=144) | 0.04 units on a scale | Standard Deviation 0.93 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 9 (n=138, n=150) | 0.10 units on a scale | Standard Deviation 0.88 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 19 (n=132, n=145) | -0.04 units on a scale | Standard Deviation 1.03 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 10 (n=139, n=150) | 0.15 units on a scale | Standard Deviation 0.96 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 14 (n=138, n=146) | 0.03 units on a scale | Standard Deviation 0.85 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 17 (n=133, n=145) | 0.00 units on a scale | Standard Deviation 0.84 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Final Day (n=147, n=153) | 0.03 units on a scale | Standard Deviation 0.94 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 11 (n=137, n=149) | 0.17 units on a scale | Standard Deviation 1.02 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Baseline (n=147, n=153) | 0.56 units on a scale | Standard Deviation 1.03 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 1 (n=135, n=143) | 0.08 units on a scale | Standard Deviation 0.71 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 21 (n=108, n=121) | 0.06 units on a scale | Standard Deviation 0.93 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 2 (n=143, n=152) | 0.07 units on a scale | Standard Deviation 0.6 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 12 (n=137, n=148) | 0.09 units on a scale | Standard Deviation 1.02 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 3 (n=141, n=152) | 0.09 units on a scale | Standard Deviation 0.65 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 4 (n=142, n=152) | 0.09 units on a scale | Standard Deviation 0.77 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 13 (n=136, n=146) | 0.02 units on a scale | Standard Deviation 0.92 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 5 (n=140, n=152) | 0.15 units on a scale | Standard Deviation 0.81 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 18 (n=137, n=146) | -0.05 units on a scale | Standard Deviation 0.91 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 6 (n=136, n=152) | 0.15 units on a scale | Standard Deviation 0.88 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 15 (n=135, n=144) | 0.08 units on a scale | Standard Deviation 0.86 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 7 (n=139, n=150) | 0.18 units on a scale | Standard Deviation 0.9 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 20 (n=126, n=136) | -0.01 units on a scale | Standard Deviation 0.97 |
| Placebo | LS Mean Change From Baseline in Total Asthma Symptom Score | Change From BL to Day 8 (n=139, n=149) | 0.12 units on a scale | Standard Deviation 0.95 |
Secondary
LS Mean Change From Baseline in Total Cold Symptom Score
Participants entered their cold symptoms into an e-diary twice daily beginning at the Screening Visit through completion of the study. The total cold symptom score was the sum of 6 scores for rhinorrhea, nasal congestion, cough, score throat, malaise, and myalgia. Each symptom is scored as follows: 0 = none-sign/symptom is not present, 1 = mild-sign/symptom noticeable but did not bother me or interfere with my normal daily activities/sleep, 2 = moderate- sign/symptom annoying and may have interfered with my normal daily activities/sleep, or 3 = severe-symptom very uncomfortable and interfered with most or all of my normal daily activities/sleep. The total score ranges from 0 to 18, with increasing scores reflecting more severe colds. Baseline values were defined as the average of the last seven assessments prior to randomization (before exposure to an index case). Pooled SDs and LS means were calculated based on an ANOVA model.
Time frame: Baseline through the Final Visit (Day 21)
Population: Efficacy analyses were based on all randomized participants (intent-to-treat principle) with at least some cold symptom score follow-up information.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 8 (n=139, n=149) | 0.02 units on a scale | Standard Deviation 1.63 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 2 (n=143, n=152) | 0.21 units on a scale | Standard Deviation 1.08 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 9 (n=138, n=150) | 0.04 units on a scale | Standard Deviation 1.63 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 10 (n=139, n=150) | 0.18 units on a scale | Standard Deviation 1.71 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 11 (n=137, n=149) | 0.17 units on a scale | Standard Deviation 1.81 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 3 (n=141, n=152) | 0.31 units on a scale | Standard Deviation 1.34 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 12 (n=137, n=148) | 0.07 units on a scale | Standard Deviation 1.77 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Baseline (n=147, n=153) | 1.09 units on a scale | Standard Deviation 1.62 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 13 (n=136, n=146) | -0.02 units on a scale | Standard Deviation 1.66 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 4 (n=142, n=152) | 0.14 units on a scale | Standard Deviation 1.41 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 14 (n=138, n=146) | 0.05 units on a scale | Standard Deviation 1.51 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 16 (n=132, n=144) | 0.04 units on a scale | Standard Deviation 1.71 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 15 (n=135, n=144) | 0.04 units on a scale | Standard Deviation 1.65 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 5 (n=140, n=152) | 0.04 units on a scale | Standard Deviation 1.43 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 6 (n=136, n=152) | -0.01 units on a scale | Standard Deviation 1.51 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 17 (n=133, n=145) | -0.06 units on a scale | Standard Deviation 1.52 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 18 (n=137, n=146) | -0.17 units on a scale | Standard Deviation 1.64 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 1 (n=135, n=143) | 0.03 units on a scale | Standard Deviation 1.05 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 19 (n=132, n=145) | -0.03 units on a scale | Standard Deviation 1.74 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 21 (n=108, n=121) | 0.15 units on a scale | Standard Deviation 1.44 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 7 (n=139, n=150) | 0.03 units on a scale | Standard Deviation 1.65 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Final Day (n=147, n=153) | 0.18 units on a scale | Standard Deviation 1.58 |
| Pleconaril | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 20 (n=126, n=136) | -0.04 units on a scale | Standard Deviation 1.63 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Final Day (n=147, n=153) | 0.23 units on a scale | Standard Deviation 1.58 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 10 (n=139, n=150) | 0.29 units on a scale | Standard Deviation 1.71 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 17 (n=133, n=145) | 0.10 units on a scale | Standard Deviation 1.52 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 19 (n=132, n=145) | -0.04 units on a scale | Standard Deviation 1.74 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 20 (n=126, n=136) | 0.17 units on a scale | Standard Deviation 1.63 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Baseline (n=147, n=153) | 0.99 units on a scale | Standard Deviation 1.62 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 1 (n=135, n=143) | 0.12 units on a scale | Standard Deviation 1.05 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 2 (n=143, n=152) | 0.26 units on a scale | Standard Deviation 1.08 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 3 (n=141, n=152) | 0.35 units on a scale | Standard Deviation 1.34 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 4 (n=142, n=152) | 0.39 units on a scale | Standard Deviation 1.41 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 6 (n=136, n=152) | 0.40 units on a scale | Standard Deviation 1.51 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 7 (n=139, n=150) | 0.38 units on a scale | Standard Deviation 1.65 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 8 (n=139, n=149) | 0.34 units on a scale | Standard Deviation 1.63 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 9 (n=138, n=150) | 0.29 units on a scale | Standard Deviation 1.63 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 11 (n=137, n=149) | 0.31 units on a scale | Standard Deviation 1.81 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 12 (n=137, n=148) | 0.25 units on a scale | Standard Deviation 1.77 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 13 (n=136, n=146) | 0.11 units on a scale | Standard Deviation 1.66 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 14 (n=138, n=146) | 0.15 units on a scale | Standard Deviation 1.51 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 15 (n=135, n=144) | 0.18 units on a scale | Standard Deviation 1.65 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 16 (n=132, n=144) | 0.21 units on a scale | Standard Deviation 1.71 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 18 (n=137, n=146) | -0.03 units on a scale | Standard Deviation 1.64 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 21 (n=108, n=121) | 0.29 units on a scale | Standard Deviation 1.44 |
| Placebo | LS Mean Change From Baseline in Total Cold Symptom Score | Change From BL to Day 5 (n=140, n=152) | 0.45 units on a scale | Standard Deviation 1.43 |