Trial · NCT00461032
Montelukast Back to School Asthma Study (0476-340)
NCT00461032, Phase 3, Completed, Organon and Co; results first posted 2010-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Montelukast Back to School Asthma Study (0476-340). Trials, record NCT00461032. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00461032
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Montelukast Back to School Asthma Study (0476-340)
- NCT number
- NCT00461032
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,162 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Asthma
- Interventions
- montelukast, Comparator: Placebo
- First posted
- 2007-04-17
- Last updated
- 2022-02-02
- Results first posted
- 2010-02-04
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| 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 | 8 Week treatment period initiated at the beginning of a school year | |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | 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. | Percentage of Days | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | 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. | Participants | NUMBER |
| 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 | 8 Week treatment period initiated at the beginning of a school year | 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. | Percentage of Days | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | 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. | Percentage of Days | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | Placebo | 27.23 | 95% Confidence Interval 24.25 to 30.00 | Percentage of Days | |
| Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | Montelukast 5 mg | 24.26 | 95% Confidence Interval 21.52 to 27.01 | Percentage of Days | |
| Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Placebo | Participants requiring Health Care Utilization | 70 | Participants | |
| Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Montelukast 5 mg | Participants requiring Health Care Utilization | 55 | Participants | |
| Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Placebo | Participants not requiring Health Care Utilization | 406 | Participants | |
| Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries) | Montelukast 5 mg | Participants not requiring Health Care Utilization | 411 | Participants | |
| 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 | Placebo | 7.02 | 95% Confidence Interval 5.80 to 8.23 | Percentage of Days | |
| 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 | Montelukast 5 mg | 6.04 | 95% Confidence Interval 4.84 to 7.24 | Percentage of Days | |
| Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | Placebo | 17.4 | 95% Confidence Interval 15.33 to 19.47 | Percentage of Days | |
| Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants | Montelukast 5 mg | 16.03 | 95% Confidence Interval 13.99 to 18.07 | Percentage of Days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 582 | |
| Overall Study | STARTED | Montelukast 5 mg | 580 | |
| Overall Study | COMPLETED | Placebo | 545 | |
| Overall Study | COMPLETED | Montelukast 5 mg | 536 | |
| Overall Study | NOT COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Montelukast 5 mg | 44 |
Source ClinicalTrials.gov
Adverse events230
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 566 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Montelukast 5 mg | 1 | 566 | |
| other | Lymphangioma | Congenital, familial and genetic disorders | Placebo | 1 | 566 | |
| other | Lymphangioma | Congenital, familial and genetic disorders | Montelukast 5 mg | 0 | 566 | |
| other | Ear pain | Ear and labyrinth disorders | Placebo | 1 | 566 | |
| other | Ear pain | Ear and labyrinth disorders | Montelukast 5 mg | 3 | 566 | |
| other | Conjunctivitis | Eye disorders | Placebo | 1 | 566 | |
| other | Conjunctivitis | Eye disorders | Montelukast 5 mg | 1 | 566 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Placebo | 0 | 566 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Montelukast 5 mg | 1 | 566 |
1 to 10 of 230Source ClinicalTrials.gov
See all 230 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Montelukast 5 mg | ||
| Total, other adverse events | Placebo | 189 | 566 |
| Total, other adverse events | Montelukast 5 mg | 191 | 566 |
| Total, serious adverse events | Placebo | 1 | 566 |
| Total, serious adverse events | Montelukast 5 mg | 4 | 566 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20674830 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Montelukast 5 mg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00461032
GET https://conductscience.org/api/trials/v1/NCT00461032/events?page=2