Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness

Asthma Clinical Trial

— SINGDEN  

Official title:

Effect of Add-on Montelukast to Inhaled Corticosteroids in Excessive Airway Narrowing in Adults With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00913328
• Other study ID #: SINGDEN-04-2002
• Status: Completed
• Phase: Phase 4
• First received: June 3, 2009
• Last updated: June 3, 2009
• Start date: August 2002
• Est. completion date: October 2006

Study information

• Verified date: June 2009
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.

Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Non-smoking adults with mild to moderate persistent asthma:

• FEV1 > 70 % pred

• PD20 methacholine < 3.9 mmol

• treated for at least 3 months with a stable dose of inhaled corticosteroids

• Documented dose-response plateau to inhaled methacholine on two occasions

• Males and non-pregnant females

Exclusion Criteria:

• Asthma medication other than inhaled corticosteroids and inhaled b2-agonists

• Viral respiratory tract infections within the 3 weeks prior to enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast (Singulair)
10 mg tablet once daily
• Placebo
Oral placebo once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in maximal FEV1 decline at the dose-response plateau		After 12 weeks of treatment	No
Secondary	Changes from baseline in PD20 methacholine		After 12 weeks of treatment	No