Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666679
• Other study ID #: 0476-386
• Secondary ID: MK0476-3862007_6
• Status: Completed
• Phase: Phase 2
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Comparator: mometasone
mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)
• Comparator: montelukast
montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)
• Comparator: placebo (unspecified)
Placebo (Placebo once-daily, for approximately 2 weeks)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Philip G, Villaran C, Shah SR, Vandormael K, Smugar SS, Reiss TF. The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. J Asthma. 2011 Jun;48(5):495-502. doi: 10.3109/0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Total Daily ß-agonist Use	To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on as-needed ß-agonist use assessed by average change from baseline in total daily ß-agonist use over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.	Baseline and 2 weeks
Other	Percentage of Days With Asthma Control	To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma control assessed by average percentage of days with asthma control over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.	2 weeks
Other	Percentage of Days With Asthma Exacerbations	To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on worsening of asthma assessed by percentage of days with asthma exacerbations during the 2 week treatment period.	2 Weeks
Other	Change From Baseline in Total Peripheral Blood Eosinophils	To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on change from baseline in total peripheral blood eosinophils during the 2 week treatment period.	Baseline and 2 weeks
Primary	Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)	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.	Baseline and 2 weeks
Secondary	Change From Baseline in Daytime Asthma Symptom Score	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.	Baseline and 2 weeks
Secondary	Change From Baseline in Nighttime Asthma Symptom Score	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.	Baseline and 2 weeks