Phase 3
Completed N=642
The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)
Source: ClinicalTrials.gov NCT00911547 ↗Enrolled (actual)
642
Serious AEs
1.9%
Results posted
Jun 2010
Primary outcomePrimary: Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma — -11.96; -5.31; 0.72; 5.08 Percentage of Change
Summary
This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma |
-11.96; -5.31; 0.72; 5.08 | — |
| PRIMARY Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma |
0.31; 0.27; -0.02; -0.13 | — |
| SECONDARY Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use |
59.20; 44.48; 6.04; -5.51 | — |
| SECONDARY Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma |
-27.10; -15.37; 2.65; 10.41 | — |
| SECONDARY Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only |
0.17; 0.18; -0.06; -0.20 | — |
Eligibility Criteria
Inclusion Criteria
- Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
- Patient was a nonsmoker
- Patient was in good general health (except for asthma)
Exclusion Criteria
- Patient was hospitalized
- Patient was female who was less than 8 weeks postpartum or breast feeding
- Patient planned to move or vacation away during the study
- Patient had major surgery within 4 weeks the past 4 weeks
- Patient has donated blood or participated in a clinical trial within the past 4 weeks
- Patient was a regular user or recent abuser of alcohol or illicit drugs
- Patient was 40% over or under normal weight for height
Data sourced from ClinicalTrials.gov (NCT00911547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.