NCT00712335

The Effects of Montelukast on Smokers With Asthma

The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Inje University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 cigarette smokers are resistant to corticosteroids.

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 activate production of IL-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics. LTRAs are felt to be less efficacious than ICS in smokers with asthma. However, LTRA's unique mechanism of action could be particularly efficacious in preventing worsening symptoms and lung function for smokers with asthma. Given this, along with the fact that ICS are less effective in smokers, targeting cysLT could lead to significant clinical benefits for asthmatic smokers. Data from this study may possibly serve as crucial data for the significant clinical benefits for asthmatic smokers and determination of the mechanism of corticosteroid resistance in smokers with asthma.

Conditions

• Asthmatic Smokers
• Non-asthmatic Smokers

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate	DPI 250 mcg BID for 3 weeks
DRUG	Montelukast	PO 10 mg QHS for 3 weeks
DRUG	Salmeterol	DPI 50mg BID for 3 weeks

Timeline

• Start date: 2007-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2008-07-09
• Last updated: 2012-05-16
• Results posted: 2012-05-16

Locations

1 site across 1 country: South Korea