Trial Outcomes & Findings for Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED) (NCT NCT00337675)
NCT ID: NCT00337675
Last Updated: 2024-05-10
Results Overview
The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1771 participants
Primary outcome timeframe
1-year treatment period
Results posted on
2024-05-10
Participant Flow
Patients were recruited from 111 centers worldwide. Patient screening began 16-Oct-2006 and the first patient was randomized on 3-Nov-2006. The last patient's last visit was completed on 12-Aug-2009.
1979 screened; 208 excluded. Randomized patients met the following criteria: age 6-71 months, a history of episodic asthma symptoms that ranged between 2 and 6 episodes, depending on age, that were separated in time by periods without asthma symptoms. Patients had at least 1 corticosteroid treatment or were hospitalized for asthma at least 1 time.
Participant milestones
| Measure |
Daily Montelukast
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
|---|---|---|---|
|
Overall Study
STARTED
|
589
|
591
|
591
|
|
Overall Study
COMPLETED
|
492
|
488
|
492
|
|
Overall Study
NOT COMPLETED
|
97
|
103
|
99
|
Reasons for withdrawal
| Measure |
Daily Montelukast
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
9
|
19
|
|
Overall Study
Lack of Efficacy
|
10
|
7
|
9
|
|
Overall Study
Lost to Follow-up
|
22
|
19
|
17
|
|
Overall Study
Physician Decision
|
9
|
17
|
14
|
|
Overall Study
Protocol Violation
|
21
|
24
|
19
|
|
Overall Study
Withdrawal by Subject
|
25
|
25
|
19
|
|
Overall Study
Progressive Disease
|
0
|
2
|
0
|
|
Overall Study
Trial Terminated
|
0
|
0
|
2
|
Baseline Characteristics
Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Daily Montelukast
n=589 Participants
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
n=591 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
n=591 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Total
n=1771 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.0 Months
n=99 Participants
|
39.5 Months
n=107 Participants
|
39.3 Months
n=206 Participants
|
39.2 Months
n=7 Participants
|
|
Sex: Female, Male
Female
|
239 Participants
n=99 Participants
|
226 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
703 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
350 Participants
n=99 Participants
|
365 Participants
n=107 Participants
|
353 Participants
n=206 Participants
|
1068 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1-year treatment periodPopulation: Full Analysis Set (FAS): all randomized patients who took at least one dose of blinded study drug. Of 1771 patients randomized, 5 never took study drug and 9 were not included due to Good Clinical Practice compliance concerns. Therefore, 1757 patients were included in the FAS population.
The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.
Outcome measures
| Measure |
Daily Montelukast
n=584 Participants
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
n=588 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
n=585 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
|---|---|---|---|
|
Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
|
0.99 Asthma attacks within episodes per year
Interval 0.86 to 1.14
|
1.06 Asthma attacks within episodes per year
Interval 0.92 to 1.22
|
1.05 Asthma attacks within episodes per year
Interval 0.92 to 1.2
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Only patients who experienced an asthma attack within an episode and did not start their intermittent study medication on the day of the attack could be included. Therefore, a total of 452 patients were included in this analysis.
Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.
Outcome measures
| Measure |
Daily Montelukast
n=138 Participants
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
n=162 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
n=152 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
|---|---|---|---|
|
Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode
|
1.69 Units on a Scale
Interval 1.49 to 1.88
|
1.70 Units on a Scale
Interval 1.52 to 1.89
|
1.88 Units on a Scale
Interval 1.69 to 2.07
|
SECONDARY outcome
Timeframe: 1 YearPopulation: Patients with at least one episode culminating in an attack were included; therefore, 1120 patients were included in the analysis.
Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.
Outcome measures
| Measure |
Daily Montelukast
n=365 Participants
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
n=387 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
n=368 Participants
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
|---|---|---|---|
|
Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes
|
1.08 Units on a Scale
Interval 1.0 to 1.16
|
1.09 Units on a Scale
Interval 1.01 to 1.17
|
1.20 Units on a Scale
Interval 1.12 to 1.28
|
Adverse Events
Daily Montelukast
Serious events: 28 serious events
Other events: 481 other events
Deaths: 0 deaths
Intermittent Montelukast
Serious events: 41 serious events
Other events: 506 other events
Deaths: 0 deaths
Placebo
Serious events: 33 serious events
Other events: 486 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daily Montelukast
n=584 participants at risk
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
n=588 participants at risk
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
n=585 participants at risk
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Diarrhoea
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Vomiting
|
0.17%
1/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Immune system disorders
Anaphylactic reaction
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Adenoiditis
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Bronchiolitis
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Bronchitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Bronchopneumonia
|
0.17%
1/584 • October 2006 through August 2009
|
0.34%
2/588 • October 2006 through August 2009
|
0.34%
2/585 • October 2006 through August 2009
|
|
Infections and infestations
Cellulitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Croup infectious
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Erysipelas
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Hepatitis viral
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Kawasaki's disease
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Laryngotracheitis obstructive
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Lobar pneumonia
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Parotid abscess
|
0.17%
1/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Pneumonia
|
0.51%
3/584 • October 2006 through August 2009
|
0.68%
4/588 • October 2006 through August 2009
|
0.68%
4/585 • October 2006 through August 2009
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Immune system disorders
Pneumonia viral
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Sinusitis
|
0.17%
1/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Tonsillitis
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Tracheitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Upper respiratory tract infection
|
0.34%
2/584 • October 2006 through August 2009
|
0.34%
2/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Varicella
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Infections and infestations
Viral diarrhoea
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Infections and infestations
Viral rash
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Injury, poisoning and procedural complications
Head injury
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
1/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Nervous system disorders
Febrile convulsion
|
0.17%
1/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Nervous system disorders
Somnolence
|
0.17%
1/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.2%
13/584 • October 2006 through August 2009
|
2.9%
17/588 • October 2006 through August 2009
|
2.4%
14/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.34%
2/584 • October 2006 through August 2009
|
0.68%
4/588 • October 2006 through August 2009
|
0.51%
3/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/584 • October 2006 through August 2009
|
0.17%
1/588 • October 2006 through August 2009
|
0.00%
0/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/584 • October 2006 through August 2009
|
0.00%
0/588 • October 2006 through August 2009
|
0.17%
1/585 • October 2006 through August 2009
|
Other adverse events
| Measure |
Daily Montelukast
n=584 participants at risk
Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Intermittent Montelukast
n=588 participants at risk
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
Placebo
n=585 participants at risk
Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
35/584 • October 2006 through August 2009
|
8.3%
49/588 • October 2006 through August 2009
|
7.4%
43/585 • October 2006 through August 2009
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
22/584 • October 2006 through August 2009
|
5.3%
31/588 • October 2006 through August 2009
|
5.1%
30/585 • October 2006 through August 2009
|
|
General disorders
Pyrexia
|
16.1%
94/584 • October 2006 through August 2009
|
14.8%
87/588 • October 2006 through August 2009
|
13.7%
80/585 • October 2006 through August 2009
|
|
Infections and infestations
Bronchitis
|
5.7%
33/584 • October 2006 through August 2009
|
6.8%
40/588 • October 2006 through August 2009
|
5.5%
32/585 • October 2006 through August 2009
|
|
Infections and infestations
Influenza
|
5.1%
30/584 • October 2006 through August 2009
|
5.3%
31/588 • October 2006 through August 2009
|
4.6%
27/585 • October 2006 through August 2009
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
110/584 • October 2006 through August 2009
|
18.7%
110/588 • October 2006 through August 2009
|
13.8%
81/585 • October 2006 through August 2009
|
|
Infections and infestations
Otitis media
|
7.5%
44/584 • October 2006 through August 2009
|
9.4%
55/588 • October 2006 through August 2009
|
7.7%
45/585 • October 2006 through August 2009
|
|
Infections and infestations
Pharyngitis
|
10.1%
59/584 • October 2006 through August 2009
|
10.9%
64/588 • October 2006 through August 2009
|
11.5%
67/585 • October 2006 through August 2009
|
|
Infections and infestations
Rhinitis
|
6.2%
36/584 • October 2006 through August 2009
|
5.6%
33/588 • October 2006 through August 2009
|
5.1%
30/585 • October 2006 through August 2009
|
|
Infections and infestations
Sinusitis
|
6.7%
39/584 • October 2006 through August 2009
|
8.3%
49/588 • October 2006 through August 2009
|
4.6%
27/585 • October 2006 through August 2009
|
|
Infections and infestations
Tonsillitis
|
6.5%
38/584 • October 2006 through August 2009
|
7.1%
42/588 • October 2006 through August 2009
|
6.3%
37/585 • October 2006 through August 2009
|
|
Infections and infestations
Upper respiratory tract infection
|
13.9%
81/584 • October 2006 through August 2009
|
12.9%
76/588 • October 2006 through August 2009
|
14.0%
82/585 • October 2006 through August 2009
|
|
Infections and infestations
Varicella
|
6.2%
36/584 • October 2006 through August 2009
|
2.6%
15/588 • October 2006 through August 2009
|
4.8%
28/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
56.8%
332/584 • October 2006 through August 2009
|
57.5%
338/588 • October 2006 through August 2009
|
54.5%
319/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.6%
91/584 • October 2006 through August 2009
|
17.2%
101/588 • October 2006 through August 2009
|
15.9%
93/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
7.9%
46/584 • October 2006 through August 2009
|
7.5%
44/588 • October 2006 through August 2009
|
5.3%
31/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.8%
22/584 • October 2006 through August 2009
|
4.9%
29/588 • October 2006 through August 2009
|
5.0%
29/585 • October 2006 through August 2009
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.7%
33/584 • October 2006 through August 2009
|
5.3%
31/588 • October 2006 through August 2009
|
6.3%
37/585 • October 2006 through August 2009
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER