Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness
NCT ID: NCT00913328
Last Updated: 2009-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2002-08-31
2006-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Montelukast
Oral montelukast 10 mg once daily for 12 weeks
Montelukast (Singulair)
10 mg tablet once daily
Placebo
Oral placebo once daily for 12 weeks
Placebo
Oral placebo once daily
Interventions
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Montelukast (Singulair)
10 mg tablet once daily
Placebo
Oral placebo once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Viral respiratory tract infections within the 3 weeks prior to enrollment
18 Years
50 Years
ALL
No
Sponsors
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Hvidovre University Hospital
OTHER
Responsible Party
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Department of Heart and Lung Diseases, Hvidovre Hospital
Principal Investigators
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Zuzana Diamant, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Charlotte S Ulrik, MD, DMSc
Role: PRINCIPAL_INVESTIGATOR
Dept. of Heart and Lung Diseases, Hvidovre Hospital, Denmark
Other Identifiers
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SINGDEN-04-2002
Identifier Type: -
Identifier Source: org_study_id
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