Rhinitis, Allergic, Rhinitis, Allergic, Perennial and Seasonal
Conditions
Keywords
Seasonal, Fluticasone Furoate, Perennial, Allergic Rhinitis, Nasal Spray
Brief summary
This Phase IV interventional study is a multi-center, randomized, double-blind, placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55 mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages 2 to 12 years with AR. This study comprises screening and run-in period (4 to14 days), double-blind treatment period (28 days) and follows up period (3 to7 days). Subjects entering the study will participate for maximum of 50 days, including five clinical visits and a follow-up contact. The study is planned to enroll approximately 360 subjects.
Interventions
DRUGFFNS
FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.
OTHERPlacebo
Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent obtained from the subject's parent/guardian. * Chinese male or non-child bearing potential female pediatric outpatients subjects who are \>=2 to \<=12 years of age at Visit 2. * Diagnosis of AR: Subjects must have a diagnosis of intermittent allergy rhinitis (IAR) \[symptoms are present \<4 days a week, or for \<4 weeks\] or persistent allergic rhinitis (PER) \[symptoms are present \>=4 days a week, or for \>=4 weeks\] by symptoms, physical signs skin prick test (SPT) and serum-specific immunoglobulin E (IgE) test. Subjects must have 2 or more symptoms of AR (watery rhinorrhea, nasal obstruction, nasal itching and sneezing), which are also present consecutively or accumulatively more than 1 hour on each day prior to Visit 1, or/and concomitant ocular symptoms: ocular itching, red eyes, watery eyes etc. The physical signs includes: nasal mucosa pale, oedema, nasal secretion. Allergic shiner and allergic crease in severity pediatric. A documented positive prick skin test and a positive serum specific IgE test using standardized allergen extract. A positive skin test is defined as a allergen wheal \>=3 millimeters (mm), a histamine \>=3 mm. Subjects have nasal symptoms described above or/and associated with ocular symptoms, as well as the nasal signs and one of laboratory test positive or demonstrate SPT represented a positive response or serum-specific IgE testing represented a positive response within 12 months prior to Visit 1. * Subject must be willing to maintain same environment throughout the study. * Subject and/or subject's parent/guardian understands and is willing, able and likely to comply with study procedures and restrictions as well as manage study drug administration.
Exclusion criteria
* Concomitant Medical Conditions: (a) Significant concomitant medical conditions defined as historical or current evidence of clinically significant uncontrolled disease of any body system. Significant is defined as any disease that, in the opinion of the investigator, would confound the interpretation of the study results if the disease/condition exacerbated during the study: significant renal impairment, which based on the opinion of the investigator, would preclude the subjects' participation in the study and current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). (NOTES: Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis and Chronic stable hepatitis B and C \[e.g., presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment\] are acceptable if subject otherwise meets entry criteria). (b) A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or frequent bleeding of the nose that could affect the deposition of double blind intranasal study drug. (c) Current or history of a Candida infection of the nose or oropharynx, shingles, chickenpox, measles, ocular herpes simplex. (d) Known hypersensitivity to corticosteroids or any excipients in the product. (e) Recent nasal septal surgery or nasal septal perforation. (f) Subjects start, discontinue or change desensitization treatment within 30 days prior to Visit 1. (g) Bacterial or viral infection of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period. (h) Asthma, with the exception of mild intermittent asthma. (i) Diagnosis of rhinitis medicamentosa, vasomotor AR or eosinophil rhinitis. * Abnormal Laboratory Findings: A clinically significant laboratory abnormality including Liver Function Tests at Visit 1 meeting the following criteria: Alanine aminotransferase (ALT) \>2 x upper limit of normal (ULN) and bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35 percent \[%\]). * Abnormal Electocardiogram (ECG): Clinically significant abnormal ECG finding at Visit 1. Significant is defined as: Corrected QT (QTc) \> 450 milliseconds (msec) or QTc \> 480 msec in subjects with Bundle Branch Block. The QTc is the QT interval corrected for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF), and/or another method, machine-read or manually over-read. The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trail. * Concomitant Medication: Use of prescription or over-the-counter medication that would significantly affect the course of AR, or interact with study drug, such as: Chronic use of concomitant medications such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug; Chronic use of long- acting beta2-agonists (e.g., salmeterol); Potent Cytochrome P450 subfamily enzyme 3A4 \[CYP3A4\] inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, etc); Allergen immunotherapy for the treatment of allergies. * Use of followings medications are not allowed throughout the study: Short-acting antihistamines, including ocular preparations and antihistamines contained in anti-cold medicine, insomnia or antalgic; Oral or inhaled anticholinergics; Oral or intranasal decongestants; Oral or intranasal antileukotrienes; Oral or inhaled long-acting beta2 agonists; Chinese traditional medicines that have potential effect to AR; Liquorice preparation; Medications that significantly inhibit the CYP3A4, including ritonavir and ketoconazole; tricyclic antidepressants; long-acting antihistamines( eg. desloratadine, fexofenadine, cetirizine and loratadine \[ taken as rescue medication\]); Intranasal antihistamines; or Intranasal or ocular cromolyh; Intranasal corticosteroids includes: Inhaled, oral, intramuscular, intravenous, ocular and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) and Immunosuppressive medications; Subcutaneous omalizumab. * Subjects will travel more than 48 hours during the study may cause the change of allergen. * Subjects, who, in the opinion of the Investigator or sub-investigators, are not able to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | Baseline and up to Week 2 | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | Baseline and up to Week 2 | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. |
| Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | Baseline and up to Week 2 | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value |
| Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | Baseline and up to Week 2 | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | Baseline and up to Week 4 | TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Week 4 | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 4 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. |
| Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | Baseline and up to Week 4 | The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis. |
| Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | Baseline and up to Week 4 | TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | Baseline and up to Week 4 | Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Week 2 | Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 2 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis. |
| Number of Participants With Clinical Chemistry Values Outside the Normal Range | Week 4 | Blood samples were collected from participants at indicated time points to evaluate clinical chemistry values outside normal range. The clinical chemistry parameters including alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, creatinine, direct bilirubin, glucose, potassium, sodium, total bilirubin, total protein and blood urea nitrogen (BUN) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Number of Participants With Hematology Values Outside Normal Range | Week 4 | Blood samples were collected from participants at indicated time points to evaluate hematology values outside normal range. The hematology parameters including basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet, red blood cells (RBC), total neutrophils, white blood cells (WBC) with values outside normal range is presented. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles). |
| Number of Participants With Urinalysis Values Outside Normal Range | Week 4 | Urine parameters including urine specific gravity and urine potential of hydrogen (pH) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Change From Baseline in Nasal Examination | Baseline and Week 4 | A detailed nasal examination of the mucosa, septum, secretions, nasal patency, size of any polyps and ulcers was performed at specific time points. Number of participants with improved or worsened conditions are presented. Improved condition was defined as increase in number of patencies and Worsened condition was defined as decrease in number of patencies, from Baseline to Week 4. The Baseline value for a nasal examination was the most recent recorded value for Week 4 before dosing on Day 1. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and Week 4 | Vital signs including SBP and DBP were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. |
| Change From Baseline in Heart Rate | Baseline and Week 4 | Vital signs including heart rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. |
| Change From Baseline in Temperature | Baseline and Week 4 | Vital signs including temperature were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. |
| Change From Baseline in Respiration Rate | Baseline and Week 4 | Vital signs including respiration rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed. |
| Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | Up to Week 4 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. |
Countries
China
Participant flow
Recruitment details
This efficacy and safety study of fluticasone furoate (FF) was conducted at 16 centers in China. A total of 505 pediatric participants with allergic rhinitis were screened; of which 147 were screen and run-in failures and 358 were randomized in a 1:1:1 ratio to receive placebo, FF 55 micrograms (µg) or FF 110 µg once daily (QD).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received one spray of placebo from nasal spray device A (placebo nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. | 120 |
| FF 55 µg QD Participants received one spray of FF 55 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (placebo nasal spray) into each nostril QD in the morning for 28-day treatment period. | 119 |
| FF 110 µg QD Participants received one spray of FF 110 µg from nasal spray device A (FF nasal spray) followed by one spray from nasal spray device B (FF nasal spray) into each nostril QD in the morning for 28-day treatment period. | 119 |
| Total | 358 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Other: Reached stopping criteria | 11 | 7 | 6 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | FF 55 µg QD | FF 110 µg QD | Total |
|---|---|---|---|---|
| Age, Continuous | 6.8 Years STANDARD_DEVIATION 2.64 | 6.9 Years STANDARD_DEVIATION 2.54 | 6.6 Years STANDARD_DEVIATION 2.54 | 6.8 Years STANDARD_DEVIATION 2.57 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 120 Participants | 119 Participants | 119 Participants | 358 Participants |
| Sex: Female, Male Female | 42 Participants | 38 Participants | 32 Participants | 112 Participants |
| Sex: Female, Male Male | 78 Participants | 81 Participants | 87 Participants | 246 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 119 | 0 / 119 |
| other Total, other adverse events | 51 / 120 | 52 / 119 | 65 / 119 |
| serious Total, serious adverse events | 0 / 120 | 0 / 119 | 1 / 119 |
Outcome results
Primary
Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period
TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline and up to Week 2
Population: Intent-To-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | -1.95 Scores on a scale | Standard Error 0.16 |
| FF 55 µg QD | Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | -3.18 Scores on a scale | Standard Error 0.16 |
| FF 110 µg QD | Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period | -3.28 Scores on a scale | Standard Error 0.16 |
p-value: <0.00195% CI: [-1.68, -0.78]ANCOVA
p-value: <0.00195% CI: [-1.77, -0.87]ANCOVA
Secondary
Change From Baseline in Heart Rate
Vital signs including heart rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.
Time frame: Baseline and Week 4
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate | -0.6 Beats per minute | Standard Deviation 8.61 |
| FF 55 µg QD | Change From Baseline in Heart Rate | -1.1 Beats per minute | Standard Deviation 12.91 |
| FF 110 µg QD | Change From Baseline in Heart Rate | -0.4 Beats per minute | Standard Deviation 11.18 |
Secondary
Change From Baseline in Respiration Rate
Vital signs including respiration rate were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.
Time frame: Baseline and Week 4
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Respiration Rate | 0.0 Breaths per minute | Standard Deviation 2.51 |
| FF 55 µg QD | Change From Baseline in Respiration Rate | -0.4 Breaths per minute | Standard Deviation 1.93 |
| FF 110 µg QD | Change From Baseline in Respiration Rate | -0.3 Breaths per minute | Standard Deviation 1.61 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital signs including SBP and DBP were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.
Time frame: Baseline and Week 4
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -1.4 Millimeter of mercury (mmHg) | Standard Deviation 11.14 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 9.95 |
| FF 55 µg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -1.4 Millimeter of mercury (mmHg) | Standard Deviation 8.96 |
| FF 55 µg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0.2 Millimeter of mercury (mmHg) | Standard Deviation 8.91 |
| FF 110 µg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 10.39 |
| FF 110 µg QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP | 0.2 Millimeter of mercury (mmHg) | Standard Deviation 8.3 |
Secondary
Change From Baseline in Temperature
Vital signs including temperature were measured in a semi-supine position after 5 minutes rest. The most recent recorded value for Week 4 before dosing on Day 1 was considered as Baseline value. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available for the specified time point were analyzed.
Time frame: Baseline and Week 4
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Temperature | -0.06 Degree Celsius | Standard Deviation 0.339 |
| FF 55 µg QD | Change From Baseline in Temperature | -0.01 Degree Celsius | Standard Deviation 0.328 |
| FF 110 µg QD | Change From Baseline in Temperature | -0.01 Degree Celsius | Standard Deviation 0.311 |
Secondary
Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period
TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline and up to Week 4
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | -2.57 Scores on a scale | Standard Error 0.17 |
| FF 55 µg QD | Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | -3.93 Scores on a scale | Standard Error 0.17 |
| FF 110 µg QD | Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period | -4.03 Scores on a scale | Standard Error 0.17 |
p-value: <0.00195% CI: [-1.83, -0.9]ANCOVA
p-value: <0.00195% CI: [-1.92, -0.99]ANCOVA
Secondary
Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period
Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline and up to Week 2
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | 12.76 Days | Standard Error 0.18 |
| FF 55 µg QD | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | 13.28 Days | Standard Error 0.18 |
| FF 110 µg QD | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period | 13.43 Days | Standard Error 0.18 |
p-value: 0.04895% CI: [0.01, 1.02]ANCOVA
p-value: 0.01195% CI: [0.16, 1.17]ANCOVA
Secondary
Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period
Loratadine was provided as a rescue medication to use if needed throughout the study treatment period. Participants were asked to document loratadine rescue medication use on the daily treatment diary. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline and up to Week 4
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | 23.74 Days | Standard Error 0.46 |
| FF 55 µg QD | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | 25.62 Days | Standard Error 0.46 |
| FF 110 µg QD | Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period | 26.41 Days | Standard Error 0.46 |
p-value: 0.00495% CI: [0.6, 3.16]ANCOVA
p-value: <0.00195% CI: [1.38, 3.95]ANCOVA
Secondary
Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period
TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline and up to Week 4
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | -1.41 Scores on a scale | Standard Error 0.1 |
| FF 55 µg QD | Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | -1.52 Scores on a scale | Standard Error 0.1 |
| FF 110 µg QD | Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period | -1.70 Scores on a scale | Standard Error 0.1 |
p-value: 0.44295% CI: [-0.38, 0.17]ANCOVA
p-value: 0.03595% CI: [-0.57, -0.02]ANCOVA
Secondary
Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks
The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis.
Time frame: Baseline and up to Week 2
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | -2.32 Scores on a scale | Standard Error 0.25 |
| FF 55 µg QD | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | -4.47 Scores on a scale | Standard Error 0.25 |
| FF 110 µg QD | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks | -4.30 Scores on a scale | Standard Error 0.24 |
p-value: <0.00195% CI: [-2.84, -1.46]ANCOVA
p-value: <0.00195% CI: [-2.66, -1.29]ANCOVA
Secondary
Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks
The nasal concha mucosa symptoms score was used to evaluate change in anterior rhinoscopy. It is a composite score of four components including swelling of inferior nasal concha mucosa, color of inferior nasal concha mucosa, watery secretion volume and description of rhinorrhea. Severity of each of the component was assessed using the scale ranging from 0 (no symptom) to 3 (severe). The 4 components were averaged to obtain a total score which ranges from 0 to 12 where a higher score means a worse nasal symptom. Baseline was defined as 4 days prior to randomization, including the morning symptom assessment on the randomization date. Change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were included in the analysis.
Time frame: Baseline and up to Week 4
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | -3.21 Scores on a scale | Standard Error 0.27 |
| FF 55 µg QD | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | -5.68 Scores on a scale | Standard Error 0.27 |
| FF 110 µg QD | Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks | -5.48 Scores on a scale | Standard Error 0.27 |
p-value: <0.00195% CI: [-3.23, -1.73]ANCOVA
p-value: <0.00195% CI: [-3.03, -1.52]ANCOVA
Secondary
Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS)
TOSS is a composite score of the three components (eye itching and burning, eye watering and eye redness) with a total score of 0 to 9. Higher score means a worse symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). The daily scores were averaged to calculate the overall/total score. Participants were instructed to provide scores and document their symptoms in a reflective manner twice daily using their diary at the same time of reflective nasal symptoms assessment. Baseline scores obtained over 4 days prior to randomization were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value
Time frame: Baseline and up to Week 2
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | -1.15 Scores on a scale | Standard Error 0.1 |
| FF 55 µg QD | Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | -1.24 Scores on a scale | Standard Error 0.1 |
| FF 110 µg QD | Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) | -1.40 Scores on a scale | Standard Error 0.1 |
p-value: 0.50395% CI: [-0.38, 0.18]ANCOVA
p-value: 0.07895% CI: [-0.53, 0.03]ANCOVA
Secondary
Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale
Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 4 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis.
Time frame: Week 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Significantly worse | 1 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Significantly improved | 22 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Moderately improved | 31 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Mildly improved | 31 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | No change | 19 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Mildly worse | 1 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Moderately worse | 1 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Moderately worse | 0 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Mildly improved | 13 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | No change | 4 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Significantly worse | 1 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Mildly worse | 0 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Significantly improved | 59 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Moderately improved | 34 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Significantly worse | 0 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Mildly worse | 0 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Mildly improved | 11 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Moderately worse | 0 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Moderately improved | 34 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | No change | 3 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale | Significantly improved | 63 Participants |
p-value: <0.00195% CI: [0.12, 0.34]Regression, Logistic
p-value: <0.00195% CI: [0.1, 0.29]Regression, Logistic
Secondary
Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale
Response was defined as effectiveness of study medication for relieving allergic rhinitis symptoms over the entire treatment period. Overall response to therapy was evaluated using the 7-point categorical scale ranging from 1 (significantly improved) to 7 (significantly worse). Number of participants showing response to therapy after the first 2 weeks have been presented. Only those participants with response to therapy over the entire treatment period were included in the analysis.
Time frame: Week 2
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Mildly worse | 3 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Moderately worse | 1 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Significantly worse | 0 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Mildly improved | 45 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Significantly improved | 13 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | No change | 21 Participants |
| Placebo | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Moderately improved | 30 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Mildly worse | 1 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Moderately improved | 48 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Mildly improved | 22 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Moderately worse | 1 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | No change | 4 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Significantly worse | 0 Participants |
| FF 55 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Significantly improved | 38 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Significantly worse | 1 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Significantly improved | 51 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Moderately improved | 33 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Mildly improved | 29 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | No change | 4 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Mildly worse | 1 Participants |
| FF 110 µg QD | Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale | Moderately worse | 0 Participants |
p-value: <0.00195% CI: [0.14, 0.39]Regression, Logistic
p-value: <0.00195% CI: [0.12, 0.33]Regression, Logistic
Secondary
Number of Participants With Change From Baseline in Nasal Examination
A detailed nasal examination of the mucosa, septum, secretions, nasal patency, size of any polyps and ulcers was performed at specific time points. Number of participants with improved or worsened conditions are presented. Improved condition was defined as increase in number of patencies and Worsened condition was defined as decrease in number of patencies, from Baseline to Week 4. The Baseline value for a nasal examination was the most recent recorded value for Week 4 before dosing on Day 1. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline and Week 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Ulcers turbinates; improved | 3 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Mucosa crusting; worsened | 4 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Septum; improved | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Secretions; worsened | 5 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Mucosa bleeding; improved | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Polyposis turbinates; worsened | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Secretions; improved | 26 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Mucosa bleeding; worsened | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Mucosa oedema; improved | 21 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Nostril patent; worsened | 8 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Polyposis turbinates; improved | 0 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Mucosa oedema; worsened | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Nostril patent; improved | 39 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Ulcers turbinates; worsened | 1 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Mucosa crusting; improved | 2 Participants |
| Placebo | Number of Participants With Change From Baseline in Nasal Examination | Septum; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Secretions; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Septum; improved | 2 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Septum; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa oedema; improved | 43 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa oedema; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa crusting; improved | 4 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa crusting; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa bleeding; improved | 1 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa bleeding; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Secretions; improved | 55 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Nostril patent; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Ulcers turbinates; improved | 2 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Ulcers turbinates; worsened | 2 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Polyposis turbinates; improved | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Polyposis turbinates; worsened | 0 Participants |
| FF 55 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Nostril patent; improved | 65 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa crusting; improved | 0 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Polyposis turbinates; worsened | 0 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Ulcers turbinates; improved | 1 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa oedema; worsened | 0 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Septum; improved | 2 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Ulcers turbinates; worsened | 1 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa oedema; improved | 48 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Nostril patent; worsened | 2 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Polyposis turbinates; improved | 0 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa bleeding; worsened | 1 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa bleeding; improved | 1 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Septum; worsened | 2 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Secretions; improved | 58 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Mucosa crusting; worsened | 2 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Nostril patent; improved | 47 Participants |
| FF 110 µg QD | Number of Participants With Change From Baseline in Nasal Examination | Secretions; worsened | 2 Participants |
Secondary
Number of Participants With Clinical Chemistry Values Outside the Normal Range
Blood samples were collected from participants at indicated time points to evaluate clinical chemistry values outside normal range. The clinical chemistry parameters including alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), calcium, creatinine, direct bilirubin, glucose, potassium, sodium, total bilirubin, total protein and blood urea nitrogen (BUN) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Week 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | AST; >normal range; n= 118, 118, 119 | 5 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALT; <normal range; n= 118, 118, 119 | 2 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Albumin; >normal range; n= 118, 118, 119 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Albumin; <normal range; n= 118, 118, 119 | 4 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALP; >normal range; n= 117, 117, 117 | 18 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALP; <normal range; n= 117, 117, 117 | 1 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALT; >normal range; n= 118, 118, 119 | 4 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | AST; <normal range; n= 118, 118, 119 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Calcium; >normal range; n= 118, 117, 116 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Calcium; <normal range; n= 118, 117, 116 | 5 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Creatinine; >normal range; n= 118, 118, 118 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Creatinine; <normal range; n= 118, 118, 118 | 41 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Direct bilirubin; >normal range; n= 118, 118, 119 | 2 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Direct bilirubin; <normal range; n= 118, 118, 119 | 3 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Glucose; >normal range; n= 116, 117, 117 | 8 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Glucose; <normal range; n= 116, 117, 117 | 2 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Potassium; >normal range; n= 118, 118, 115 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Potassium; <normal range; n= 118, 118, 115 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Sodium; >normal range; n= 118, 118, 116 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Sodium; <normal range; n= 118, 118, 116 | 3 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total bilirubin; >normal range; n= 117, 118, 118 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total bilirubin; <normal range; n= 117, 118, 118 | 11 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total protein; >normal range; n= 118, 118, 119 | 0 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total protein; <normal range; n= 118, 118, 119 | 8 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | BUN; >normal range; n= 118, 118, 118 | 2 Participants |
| Placebo | Number of Participants With Clinical Chemistry Values Outside the Normal Range | BUN: <normal range; n= 118, 118, 118 | 6 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Calcium; >normal range; n= 118, 117, 116 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total bilirubin; >normal range; n= 117, 118, 118 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Calcium; <normal range; n= 118, 117, 116 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Creatinine; >normal range; n= 118, 118, 118 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | BUN; >normal range; n= 118, 118, 118 | 6 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Creatinine; <normal range; n= 118, 118, 118 | 40 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total bilirubin; <normal range; n= 117, 118, 118 | 10 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Direct bilirubin; >normal range; n= 118, 118, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Direct bilirubin; <normal range; n= 118, 118, 119 | 6 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Glucose; >normal range; n= 116, 117, 117 | 5 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total protein; >normal range; n= 118, 118, 119 | 1 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Glucose; <normal range; n= 116, 117, 117 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Potassium; >normal range; n= 118, 118, 115 | 1 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Potassium; <normal range; n= 118, 118, 115 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALT; >normal range; n= 118, 118, 119 | 2 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALT; <normal range; n= 118, 118, 119 | 3 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total protein; <normal range; n= 118, 118, 119 | 5 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Albumin; >normal range; n= 118, 118, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Sodium; >normal range; n= 118, 118, 116 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Albumin; <normal range; n= 118, 118, 119 | 1 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALP; >normal range; n= 117, 117, 117 | 21 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALP; <normal range; n= 117, 117, 117 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Sodium; <normal range; n= 118, 118, 116 | 5 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | AST; >normal range; n= 118, 118, 119 | 2 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | AST; <normal range; n= 118, 118, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | BUN: <normal range; n= 118, 118, 118 | 4 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | AST; >normal range; n= 118, 118, 119 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALP; >normal range; n= 117, 117, 117 | 22 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALT; >normal range; n= 118, 118, 119 | 1 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Calcium; <normal range; n= 118, 117, 116 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total bilirubin; >normal range; n= 117, 118, 118 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Potassium; <normal range; n= 118, 118, 115 | 0 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Creatinine; >normal range; n= 118, 118, 118 | 0 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total protein; <normal range; n= 118, 118, 119 | 5 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALT; <normal range; n= 118, 118, 119 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Creatinine; <normal range; n= 118, 118, 118 | 49 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Sodium; <normal range; n= 118, 118, 116 | 3 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | ALP; <normal range; n= 117, 117, 117 | 0 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Direct bilirubin; >normal range; n= 118, 118, 119 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total bilirubin; <normal range; n= 117, 118, 118 | 15 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Albumin; >normal range; n= 118, 118, 119 | 0 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Direct bilirubin; <normal range; n= 118, 118, 119 | 8 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | BUN; >normal range; n= 118, 118, 118 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Calcium; >normal range; n= 118, 117, 116 | 4 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Glucose; >normal range; n= 116, 117, 117 | 5 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | AST; <normal range; n= 118, 118, 119 | 0 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Albumin; <normal range; n= 118, 118, 119 | 1 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Glucose; <normal range; n= 116, 117, 117 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Total protein; >normal range; n= 118, 118, 119 | 4 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Sodium; >normal range; n= 118, 118, 116 | 0 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | Potassium; >normal range; n= 118, 118, 115 | 2 Participants |
| FF 110 µg QD | Number of Participants With Clinical Chemistry Values Outside the Normal Range | BUN: <normal range; n= 118, 118, 118 | 4 Participants |
Secondary
Number of Participants With Hematology Values Outside Normal Range
Blood samples were collected from participants at indicated time points to evaluate hematology values outside normal range. The hematology parameters including basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet, red blood cells (RBC), total neutrophils, white blood cells (WBC) with values outside normal range is presented. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Time frame: Week 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Hemoglobin; >normal range; n= 118, 119, 118 | 0 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Basophils; <normal range; n= 87, 82, 94 | 0 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Eosinophils; >normal range; n= 118, 119, 119 | 67 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Eosionophils; <normal range; n= 118, 119, 119 | 0 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Hematocrit; >normal range; n= 118, 119, 119 | 1 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Hematocrit; <normal range; n= 118, 119, 119 | 32 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Basophils; >normal range; n= 87, 82, 94 | 6 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Hemoglobin; <normal range; n= 118, 119, 118 | 4 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Lymphocytes; >normal range; n= 118, 119, 119 | 37 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Lymphocytes; <normal range; n= 118, 119, 119 | 2 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | MCH; >normal range; n= 118, 119, 119 | 0 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | MCH; <normal range; n= 118, 119, 119 | 26 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | MCV; >normal range; n= 118, 119, 119 | 0 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | MCV: <normal range; n= 118, 119, 119 | 33 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Monocytes; >normal range; n= 118, 119, 119 | 3 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Monocytes; <normal range; n= 118, 119, 119 | 1 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Platelet; >normal range; n= 118, 119, 119 | 45 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Platelet; <normal range; n= 118, 119, 119 | 0 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | RBC; >normal range; n= 118, 119, 119 | 12 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | RBC: <normal range; n= 118, 119, 119 | 0 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Total neutrophils; >normal range; n= 118, 119, 119 | 2 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | Total neutrophils; <normal range; n= 118, 119, 119 | 30 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | WBC; >normal range; n= 118, 119, 119 | 16 Participants |
| Placebo | Number of Participants With Hematology Values Outside Normal Range | WBC; <normal range; n= 118, 119, 119 | 2 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Total neutrophils; <normal range; n= 118, 119, 119 | 27 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Basophils; >normal range; n= 87, 82, 94 | 3 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCV; >normal range; n= 118, 119, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Platelet; >normal range; n= 118, 119, 119 | 33 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Basophils; <normal range; n= 87, 82, 94 | 0 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCH; >normal range; n= 118, 119, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Total neutrophils; >normal range; n= 118, 119, 119 | 5 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Eosinophils; >normal range; n= 118, 119, 119 | 65 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCV: <normal range; n= 118, 119, 119 | 34 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | WBC; >normal range; n= 118, 119, 119 | 17 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Eosionophils; <normal range; n= 118, 119, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Lymphocytes; <normal range; n= 118, 119, 119 | 11 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Platelet; <normal range; n= 118, 119, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hematocrit; >normal range; n= 118, 119, 119 | 0 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Monocytes; >normal range; n= 118, 119, 119 | 8 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCH; <normal range; n= 118, 119, 119 | 27 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hematocrit; <normal range; n= 118, 119, 119 | 28 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Lymphocytes; >normal range; n= 118, 119, 119 | 32 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | WBC; <normal range; n= 118, 119, 119 | 1 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hemoglobin; >normal range; n= 118, 119, 118 | 3 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Monocytes; <normal range; n= 118, 119, 119 | 2 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | RBC; >normal range; n= 118, 119, 119 | 14 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hemoglobin; <normal range; n= 118, 119, 118 | 8 Participants |
| FF 55 µg QD | Number of Participants With Hematology Values Outside Normal Range | RBC: <normal range; n= 118, 119, 119 | 2 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hemoglobin; <normal range; n= 118, 119, 118 | 6 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Lymphocytes; >normal range; n= 118, 119, 119 | 32 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Lymphocytes; <normal range; n= 118, 119, 119 | 1 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCH; >normal range; n= 118, 119, 119 | 1 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | RBC: <normal range; n= 118, 119, 119 | 0 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCH; <normal range; n= 118, 119, 119 | 19 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | WBC; >normal range; n= 118, 119, 119 | 17 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCV; >normal range; n= 118, 119, 119 | 0 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | MCV: <normal range; n= 118, 119, 119 | 27 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Total neutrophils; >normal range; n= 118, 119, 119 | 5 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Monocytes; >normal range; n= 118, 119, 119 | 9 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | WBC; <normal range; n= 118, 119, 119 | 2 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Monocytes; <normal range; n= 118, 119, 119 | 3 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Basophils; >normal range; n= 87, 82, 94 | 7 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Basophils; <normal range; n= 87, 82, 94 | 0 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Platelet; >normal range; n= 118, 119, 119 | 40 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Eosinophils; >normal range; n= 118, 119, 119 | 54 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Total neutrophils; <normal range; n= 118, 119, 119 | 23 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Eosionophils; <normal range; n= 118, 119, 119 | 1 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hematocrit; >normal range; n= 118, 119, 119 | 0 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Platelet; <normal range; n= 118, 119, 119 | 0 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hematocrit; <normal range; n= 118, 119, 119 | 29 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | Hemoglobin; >normal range; n= 118, 119, 118 | 3 Participants |
| FF 110 µg QD | Number of Participants With Hematology Values Outside Normal Range | RBC; >normal range; n= 118, 119, 119 | 14 Participants |
Secondary
Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function.
Time frame: Up to Week 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | non-SAEs | 51 Participants |
| Placebo | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | SAEs | 0 Participants |
| FF 55 µg QD | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | non-SAEs | 52 Participants |
| FF 55 µg QD | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | SAEs | 0 Participants |
| FF 110 µg QD | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | non-SAEs | 65 Participants |
| FF 110 µg QD | Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period | SAEs | 1 Participants |
Secondary
Number of Participants With Urinalysis Values Outside Normal Range
Urine parameters including urine specific gravity and urine potential of hydrogen (pH) with values outside normal range is presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Time frame: Week 4
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Urinalysis Values Outside Normal Range | Specific gravity; <normal range; n=102, 103, 98 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Values Outside Normal Range | pH; <normal range; n=108, 104, 103 | 1 Participants |
| Placebo | Number of Participants With Urinalysis Values Outside Normal Range | pH; >normal range; n=108, 104, 103 | 3 Participants |
| Placebo | Number of Participants With Urinalysis Values Outside Normal Range | Specific gravity; >normal range; n=102, 103, 98 | 6 Participants |
| FF 55 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | pH; >normal range; n=108, 104, 103 | 4 Participants |
| FF 55 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | pH; <normal range; n=108, 104, 103 | 3 Participants |
| FF 55 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | Specific gravity; <normal range; n=102, 103, 98 | 2 Participants |
| FF 55 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | Specific gravity; >normal range; n=102, 103, 98 | 7 Participants |
| FF 110 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | pH; <normal range; n=108, 104, 103 | 1 Participants |
| FF 110 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | Specific gravity; >normal range; n=102, 103, 98 | 2 Participants |
| FF 110 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | pH; >normal range; n=108, 104, 103 | 6 Participants |
| FF 110 µg QD | Number of Participants With Urinalysis Values Outside Normal Range | Specific gravity; <normal range; n=102, 103, 98 | 3 Participants |