Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00666679
First received: April 23, 2008
Last updated: April 20, 2010
Last verified: April 2010
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Purpose
This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Comparator: mometasone Drug: Comparator: montelukast Drug: Comparator: placebo (unspecified) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma |
Resource links provided by NLM:
Drug Information available for:
Mometasone furoate
Mometasone furoate monohydrate
Montelukast sodium
Montelukast
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
Secondary Outcome Measures:
- Change From Baseline in Daytime Asthma Symptom Score [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
- Change From Baseline in Nighttime Asthma Symptom Score [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
| Enrollment: | 134 |
| Study Start Date: | May 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
mometasone
|
Drug: Comparator: mometasone
mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)
|
|
Placebo Comparator: 2
montelukast followed by placebo; or placebo followed by montelukast.
|
Drug: Comparator: montelukast
montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)
Drug: Comparator: placebo (unspecified)
Placebo (Placebo once-daily, for approximately 2 weeks)
|
Detailed Description:
During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.
Eligibility| Ages Eligible for Study: | 15 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler
- Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator
Exclusion Criteria:
- Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
- Has required an oral corticosteroid rescue for worsening asthma during the screening period
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00666679 History of Changes |
| Other Study ID Numbers: | 2007_654, MK0476-386 |
| Study First Received: | April 23, 2008 |
| Results First Received: | January 7, 2010 |
| Last Updated: | April 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mometasone furoate Montelukast |
Anti-Allergic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on June 18, 2013