Trial Outcomes & Findings for Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma (NCT NCT00079937)
NCT ID: NCT00079937
Last Updated: 2012-04-11
Results Overview
A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
628 participants
Primary outcome timeframe
Baseline to end of the fixed-dose steroid treatment period (Week 24)
Results posted on
2012-04-11
Participant Flow
Participant milestones
| Measure |
Omalizumab
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
421
|
207
|
|
Overall Study
COMPLETED
|
352
|
175
|
|
Overall Study
NOT COMPLETED
|
69
|
32
|
Reasons for withdrawal
| Measure |
Omalizumab
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
2
|
|
Overall Study
Subject no longer requires study drug
|
3
|
0
|
|
Overall Study
Protocol Violation
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
21
|
7
|
|
Overall Study
Lost to Follow-up
|
12
|
5
|
|
Overall Study
Administrative problems
|
22
|
11
|
Baseline Characteristics
Efficacy and Safety of Omalizumab in Children (6 - < 12 Years) With Moderate-severe, Inadequately Controlled Allergic Asthma
Baseline characteristics by cohort
| Measure |
Omalizumab
n=421 Participants
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=207 Participants
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Total
n=628 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
8.7 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
8.4 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
8.6 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
287 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
425 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
69 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
249 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
103 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of the fixed-dose steroid treatment period (Week 24)Population: Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.
A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.
Outcome measures
| Measure |
Omalizumab
n=384 Participants
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=192 Participants
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period
|
0.45 Exacerbations per patient per 24-weeks
Interval 0.36 to 0.55
|
0.64 Exacerbations per patient per 24-weeks
Interval 0.49 to 0.83
|
PRIMARY outcome
Timeframe: Baseline to end of the study (Week 68)Population: Safety population: All patients who received any study drug and had at least 1 post-baseline safety assessment.
See Adverse Events module for details.
Outcome measures
| Measure |
Omalizumab
n=421 Participants
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=207 Participants
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Percentage of Participants With at Least 1 Adverse Event
|
90.3 Percentage of participants
|
93.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment periodPopulation: Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.
Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question "How did you sleep last night?", with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement.
Outcome measures
| Measure |
Omalizumab
n=382 Participants
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=191 Participants
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
|
-0.63 Units on a scale
Standard Deviation 0.72
|
-0.50 Units on a scale
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline to end of the treatment period (Week 52)Population: Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.
A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period.
Outcome measures
| Measure |
Omalizumab
n=384 Participants
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=192 Participants
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period
|
0.78 Exacerbations per patient per year
Interval 0.65 to 0.94
|
1.36 Exacerbations per patient per year
Interval 0.92 to 1.71
|
SECONDARY outcome
Timeframe: Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment periodPopulation: Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.
Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication.
Outcome measures
| Measure |
Omalizumab
n=381 Participants
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=191 Participants
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period
|
-1.3 Puffs
Standard Deviation 2.84
|
-1.0 Puffs
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)Population: Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.
PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates.
Outcome measures
| Measure |
Omalizumab
n=375 Participants
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=187 Participants
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)
Activity limitation
|
0.85 Units on a scale
Interval 0.72 to 0.99
|
0.76 Units on a scale
Interval 0.59 to 0.93
|
|
Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)
Emotional function
|
0.89 Units on a scale
Interval 0.76 to 1.03
|
0.91 Units on a scale
Interval 0.74 to 1.09
|
|
Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)
Symptoms
|
0.99 Units on a scale
Interval 0.85 to 1.13
|
0.93 Units on a scale
Interval 0.76 to 1.1
|
|
Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)
Overall (total)
|
0.92 Units on a scale
Interval 0.8 to 1.05
|
0.89 Units on a scale
Interval 0.73 to 1.05
|
Adverse Events
Omalizumab
Serious events: 27 serious events
Other events: 374 other events
Deaths: 0 deaths
Placebo
Serious events: 26 serious events
Other events: 194 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omalizumab
n=421 participants at risk
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=207 participants at risk
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/421
|
0.48%
1/207
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/421
|
0.48%
1/207
|
|
Immune system disorders
Drug hypersensitivity
|
0.24%
1/421
|
0.00%
0/207
|
|
Infections and infestations
Acute sinusitis
|
0.24%
1/421
|
0.00%
0/207
|
|
Infections and infestations
Appendicitis
|
0.71%
3/421
|
0.48%
1/207
|
|
Infections and infestations
Bronchitis
|
0.48%
2/421
|
0.48%
1/207
|
|
Infections and infestations
Bronchitis bacterial
|
0.24%
1/421
|
0.00%
0/207
|
|
Infections and infestations
Croup infectious
|
0.24%
1/421
|
0.00%
0/207
|
|
Infections and infestations
Gastroenteritis shigella
|
0.48%
2/421
|
0.00%
0/207
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/421
|
0.48%
1/207
|
|
Infections and infestations
Meningitis
|
0.00%
0/421
|
0.48%
1/207
|
|
Infections and infestations
Otitis media
|
0.24%
1/421
|
0.00%
0/207
|
|
Infections and infestations
Pneumonia
|
0.71%
3/421
|
2.9%
6/207
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.24%
1/421
|
0.00%
0/207
|
|
Infections and infestations
Sinusitis
|
0.00%
0/421
|
0.48%
1/207
|
|
Infections and infestations
Upper respiratory tract infection
|
0.24%
1/421
|
0.00%
0/207
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/421
|
0.97%
2/207
|
|
Injury, poisoning and procedural complications
Head injury
|
0.24%
1/421
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.24%
1/421
|
0.00%
0/207
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.24%
1/421
|
0.00%
0/207
|
|
Metabolism and nutrition disorders
Dehydration
|
0.24%
1/421
|
0.00%
0/207
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medulloblastoma
|
0.00%
0/421
|
0.48%
1/207
|
|
Nervous system disorders
Convulsion
|
0.24%
1/421
|
0.48%
1/207
|
|
Nervous system disorders
Syncope vasovagal
|
0.24%
1/421
|
0.00%
0/207
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/421
|
0.48%
1/207
|
|
Psychiatric disorders
Bipolar disorder
|
0.24%
1/421
|
0.00%
0/207
|
|
Psychiatric disorders
Suicide attempt
|
0.24%
1/421
|
0.00%
0/207
|
|
Psychiatric disorders
Tic
|
0.24%
1/421
|
0.00%
0/207
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.0%
17/421
|
8.7%
18/207
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.24%
1/421
|
0.00%
0/207
|
Other adverse events
| Measure |
Omalizumab
n=421 participants at risk
Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
Placebo
n=207 participants at risk
Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.5%
23/421
|
5.8%
12/207
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
20/421
|
5.8%
12/207
|
|
Gastrointestinal disorders
Vomiting
|
8.1%
34/421
|
11.6%
24/207
|
|
General disorders
Pyrexia
|
14.0%
59/421
|
9.7%
20/207
|
|
Infections and infestations
Bronchitis
|
8.6%
36/421
|
14.0%
29/207
|
|
Infections and infestations
Ear infection
|
5.2%
22/421
|
5.3%
11/207
|
|
Infections and infestations
Gastroenteritis
|
4.5%
19/421
|
7.2%
15/207
|
|
Infections and infestations
Gastroenteritis viral
|
5.5%
23/421
|
3.4%
7/207
|
|
Infections and infestations
Influenza
|
12.1%
51/421
|
13.5%
28/207
|
|
Infections and infestations
Nasopharyngitis
|
27.8%
117/421
|
27.1%
56/207
|
|
Infections and infestations
Pharyngitis
|
8.6%
36/421
|
8.7%
18/207
|
|
Infections and infestations
Pharyngitis streptococcal
|
4.5%
19/421
|
6.3%
13/207
|
|
Infections and infestations
Rhinitis
|
5.9%
25/421
|
9.7%
20/207
|
|
Infections and infestations
Sinusitis
|
16.6%
70/421
|
18.4%
38/207
|
|
Infections and infestations
Tonsillitis
|
1.7%
7/421
|
5.3%
11/207
|
|
Infections and infestations
Upper respiratory tract infection
|
16.2%
68/421
|
22.2%
46/207
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.1%
34/421
|
12.6%
26/207
|
|
Nervous system disorders
Headache
|
13.8%
58/421
|
15.9%
33/207
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
68.9%
290/421
|
82.1%
170/207
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
44/421
|
12.1%
25/207
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.8%
33/421
|
7.7%
16/207
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
8.3%
35/421
|
9.2%
19/207
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER