The Effects of Montelukast on Smokers With Asthma

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Inje University
• Treatments: Fluticasone; Leukotriene Antagonists; Montelukast; Salmeterol Xinafoate; Xhance

Criteria

Inclusion Criteria:

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 Criteria:

• 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