Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Comparator: mometasone (Drug); Comparator: montelukast (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study assesses inhaled corticosteroid plus montelukast compared with inhaled
corticosteroid therapy alone for treatment of patients with chronic asthma.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: FEV1 (Forced Expiratory Volume; volume of air that is exhaled during the first second of a forced exhalation)
Secondary outcome: asthma symptoms
Detailed description:
During this study, all patients will receive mometasone (powder, 220 ug 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
Minimum age: 15 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
- Patient has decreased breathing capacity (when not taking asthma medicine) that
improves after taking a fast-acting asthma inhaler
Exclusion Criteria:
- Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene
antagonists, or any of their components
- Patient has required an oral corticosteroid rescue for worsening asthma during the
screening period
- Patient has taken aspirin and nonsteroidal anti-inflammatory medication in patients
known to be sensitive OR patient has not had previous exposure to these compounds
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Merck Sharp & Dohme Co. Ltd., Petah Tikva 49192, Israel; Recruiting
Raanan Cohen, Phone: 972-3-9274005
Merck Sharp & Dohme De Mexico, S.A. De C.V., Mexico, D.F. 1090, Mexico; Recruiting
Juan Diaz, Phone: 52-55-5481-9825
Merck Sharp & Dohme Ltd., Hoddesdon, Hertfordshire EN11 9BU, United Kingdom; Recruiting
Paul Robinson, Phone: 44 1992 452396
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: January 2008
Ending date: March 2009
Last updated: January 30, 2009
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