Trial · NCT00115297
Montelukast for Early Life Wheezing
NCT00115297, Phase 2, Phase 3, Completed, University of Massachusetts, Worcester; results first posted 2017-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Montelukast for Early Life Wheezing. Trials, record NCT00115297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00115297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Montelukast for Early Life Wheezing
- NCT number
- NCT00115297
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 62 participants, actual
- Lead sponsor
- University of Massachusetts, Worcester
- Conditions
- Lung Diseases, Asthma
- Interventions
- Montelukast, Placebo
- First posted
- 2005-06-22
- Last updated
- 2017-03-14
- Results first posted
- 2017-02-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) | First 56 days of study | |
| Secondary | Wheezing at Day 7 | Study day 7 | |
| Secondary | The Number of Participants Requiring Rescue Beta Agonist Use | Measured during the daytime |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) | First 56 days of study | Days | MEDIAN | |
| SECONDARY | Wheezing at Day 7 | Study day 7 | participants | NUMBER | |
| SECONDARY | The Number of Participants Requiring Rescue Beta Agonist Use | Measured during the daytime | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) | Montelukast | 25.5 | Inter-Quartile Range 10.8 to 37.0 | Days | |
| Number of Wheezing-free Days of Infant (Observed by Primary Caregiver) | Placebo | 30.5 | Inter-Quartile Range 7.5 to 39.8 | Days | |
| Wheezing at Day 7 | Montelukast | 10 | participants | ||
| Wheezing at Day 7 | Placebo | 22 | participants | ||
| The Number of Participants Requiring Rescue Beta Agonist Use | Montelukast | 15 | participants | ||
| The Number of Participants Requiring Rescue Beta Agonist Use | Placebo | 26 | participants |
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 | Monteluksat | 30 | |
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | COMPLETED | Monteluksat | 30 | |
| Overall Study | COMPLETED | Placebo | 32 | |
| Overall Study | NOT COMPLETED | Monteluksat | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Montelukast | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Montelukast | 0 | 30 |
| Total, other adverse events | Placebo | 0 | 32 |
| Total, serious adverse events | Montelukast | 0 | 30 |
| Total, serious adverse events | Placebo | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HL080073 | Prostaglandins, Leukotrienes, and Innate Immunity | LILLY, CRAIG M | UNIV OF MASSACHUSETTS MED SCH WORCESTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2004 to 2008 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Montelukast vs Placebo: Wheezing at Day 7 | Trial comparisons |
| Montelukast vs Placebo: The Number of Participants Requiring Rescue Beta Agonist Use | Trial comparisons |
| Montelukast vs Placebo: serious adverse events | 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/NCT00115297
GET https://conductscience.org/api/trials/v1/NCT00115297/registered