Status:
COMPLETED
The Effects of Montelukast on Smokers With Asthma
Lead Sponsor:
Inje University
Conditions:
Asthmatic Smokers
Non-asthmatic Smokers
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is: 1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers. 2. To elucidate the mechanism by which cigarett...
Detailed Description
Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of cysLTs. CysLTs could ...
Eligibility Criteria
Inclusion
- Asthmatics:
- clinical history of asthma for at least 1 year
- with evidence of reversible airway obstruction,
- two documented FEV1 between 60-85%,
- PC20 \< 4mg/ml by methacholine challenge test
- and average baseline β-agonist use of 2 puffs/day
- Smokers:
- smoke 1/2 to 2 packs a day
- with a smoking history of 5-30 pack years
- Non-smokers:
- Non-smokers will have either never smoked or have stopped smoking cigarettes over 5 years ago
Exclusion
- positive HCG (for females)
- have a respiratory tract infection or need oral corticosteroids within the preceding 6 weeks
- history of COPD or respiratory disorder other than asthma
- history of psychiatric illness
- allergy to fluticasone propionate, salmeterol, montelukast or any of their components
- significant, unstable medical condition other than asthma
- history of life-threatening asthma exacerbation requiring intubation and mechanical ventilation in the last ten years
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00712335
Start Date
February 1 2007
End Date
May 1 2011
Last Update
May 16 2012
Active Locations (1)
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1
Asthma and Allergy Center, Inje University Sanggye Paik Hospital
Seoul, South Korea, 139-707