Asthma
Conditions
Brief summary
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.
Interventions
DRUGmontelukast sodium
montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
DRUGComparator: Placebo
Placebo. Up to 3 weeks of treatment
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season * Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens
Exclusion criteria
* Patient cannot have any other acute or chronic pulmonary disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 | Baseline and week 3 | Percent change from baseline in FEV1, a measure of airway function, at Week 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period | Baseline and Week 3 | Percent change from baseline in average daily β-agonist use over the 3-week treatment period |
Participant flow
Recruitment details
One hundred three sites in US; Prime Therapy: March 2006 to July 2007
Pre-assignment details
Patients who had unresolved symptoms and signs of an upper respiratory tract infection between Visits 1 and 2, or had evidence of active, clinically significant sinus infection within 1 week of Visit 1 or between Visits 1 and 2, or failed to meet minimum requirement for daytime asthma symptoms and daily β-agonist use were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Montelukast 5 mg Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks. | 203 |
| Placebo Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks. | 218 |
| Total | 421 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 5 |
| Overall Study | Did not meet eligibility | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Montelukast 5 mg |
|---|---|---|---|
| Age, Continuous | 10.7 years STANDARD_DEVIATION 2.4 | 10.6 years STANDARD_DEVIATION 2.4 | 10.6 years STANDARD_DEVIATION 2.4 |
| Daily β-agonist use | 2.72 Puffs/Day STANDARD_DEVIATION 1.68 | 2.86 Puffs/Day STANDARD_DEVIATION 1.73 | 3.01 Puffs/Day STANDARD_DEVIATION 1.77 |
| Forced expiratory volume in 1 second (FEV1) | 1.84 Liters STANDARD_DEVIATION 0.6 | 1.83 Liters STANDARD_DEVIATION 0.58 | 1.81 Liters STANDARD_DEVIATION 0.57 |
| Sex: Female, Male Female | 90 Participants | 171 Participants | 81 Participants |
| Sex: Female, Male Male | 128 Participants | 250 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 203 | 0 / 217 |
| serious Total, serious adverse events | 0 / 203 | 4 / 217 |
Outcome results
Primary
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3
Percent change from baseline in FEV1, a measure of airway function, at Week 3
Time frame: Baseline and week 3
Population: The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Montelukast 5 mg | Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 | 9.53 Percent Change |
| Placebo | Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 | 9.15 Percent Change |
Secondary
Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period
Percent change from baseline in average daily β-agonist use over the 3-week treatment period
Time frame: Baseline and Week 3
Population: The full analysis set population (i.e., includes all patients who had baseline and on-treatment measurements).
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Montelukast 5 mg | Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period | -18.88 Percent Change | Standard Deviation 84.75 |
| Placebo | Percent Change From Baseline in Mean Daily as Needed β-agonist Use Over the 3-week Treatment Period | -12.40 Percent Change | Standard Deviation 53.88 |