Asthma
Conditions
Brief summary
This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.
Interventions
DRUGmontelukast
montelukast 5 mg tablet Once a day (QD) for 8 weeks
DRUGComparator: Placebo
Placebo to montelukast QD for 8 weeks
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 non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1
Exclusion criteria
* Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 8 Week treatment period initiated at the beginning of a school year | A day of worsening asthma is a day with: increase from baseline in β-agonist use (\> 70% and a min increase of 2 puffs); \> 50% increase from baseline in daytime symptoms score; awake all night; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | 8 Week treatment period initiated at the beginning of a school year | Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting. |
| Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 8 Week treatment period initiated at the beginning of a school year | — |
| Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 8 Week treatment period initiated at the beginning of a school year | Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions. |
Participant flow
Recruitment details
Participants were randomized at 165 sites in the US and Canada. Therapy period: June to November 2006 (including screening period).
Pre-assignment details
Participants who were hospitalized for asthma in the 4 weeks prior to randomization or who required excluded medications were excluded from randomization.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks. | 582 |
| Montelukast 5 mg Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks. | 580 |
| Total | 1,162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 6 |
| Overall Study | Lack of Efficacy | 5 | 1 |
| Overall Study | Lost to Follow-up | 7 | 12 |
| Overall Study | Other | 7 | 5 |
| Overall Study | Patient Moved or Relocated | 2 | 1 |
| Overall Study | Protocol Violation | 4 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 15 |
Baseline characteristics
| Characteristic | Total | Placebo | Montelukast 5 mg |
|---|---|---|---|
| Age, Continuous | 9.9 years STANDARD_DEVIATION 2.5 | 9.9 years STANDARD_DEVIATION 2.5 | 9.9 years STANDARD_DEVIATION 2.4 |
| Daytime Asthma Symptom Score | 1.34 Units on a Scale STANDARD_DEVIATION 1.88 | 1.32 Units on a Scale STANDARD_DEVIATION 1.81 | 1.35 Units on a Scale STANDARD_DEVIATION 1.94 |
| Sex: Female, Male Female | 461 Participants | 236 Participants | 225 Participants |
| Sex: Female, Male Male | 701 Participants | 346 Participants | 355 Participants |
| β-Agonist Use | 0.58 puffs/day STANDARD_DEVIATION 1.03 | 0.62 puffs/day STANDARD_DEVIATION 1.11 | 0.54 puffs/day STANDARD_DEVIATION 0.94 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 189 / 566 | 191 / 566 |
| serious Total, serious adverse events | 1 / 566 | 4 / 566 |
Outcome results
Primary
Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
A day of worsening asthma is a day with: increase from baseline in β-agonist use (\> 70% and a min increase of 2 puffs); \> 50% increase from baseline in daytime symptoms score; awake all night; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.
Time frame: 8 Week treatment period initiated at the beginning of a school year
Population: The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 27.23 Percentage of Days |
| Montelukast 5 mg | Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 24.26 Percentage of Days |
Secondary
Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.
Time frame: 8 Week treatment period initiated at the beginning of a school year
Population: The analysis was based on the FAS population. This included all randomized participants who received at least 1 dose of study medication and had a valid efficacy measurement. Occurrence of one or more health care utilization was derived from the available diary data and was set to missing if no diary data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Participants requiring Health Care Utilization | 70 Participants |
| Placebo | Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Participants not requiring Health Care Utilization | 406 Participants |
| Montelukast 5 mg | Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Participants requiring Health Care Utilization | 55 Participants |
| Montelukast 5 mg | Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Participants not requiring Health Care Utilization | 411 Participants |
Secondary
Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.
Time frame: 8 Week treatment period initiated at the beginning of a school year
Population: The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. Variables that were measured as the average over the treatment period were defined from at least 7 days of evaluable diary data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 17.4 Percentage of Days |
| Montelukast 5 mg | Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 16.03 Percentage of Days |
Secondary
Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Time frame: 8 Week treatment period initiated at the beginning of a school year
Population: The secondary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had valid efficacy measurement for at least 7 days of diary data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 7.02 Percentage of Days |
| Montelukast 5 mg | Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | 6.04 Percentage of Days |