The Effects of Montelukast on Smokers With Asthma

Inje University105 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

105

Conditions

Asthmatic Smokers Non-asthmatic Smokers

Interventions

Fluticasone PropionateDRUG

DPI 250 mcg BID for 3 weeks

MontelukastDRUG

PO 10 mg QHS for 3 weeks

SalmeterolDRUG

DPI 50mg BID for 3 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Asthma and Allergy Center, Inje University Sanggye Paik Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Sputum Neutrophil Percentages

Week 24 sputum neutrophil percentages were measured in active treatment groups.

Time frame: 24 weeks

Secondary Outcomes

Sputum Eosinophil Percentages

Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups

Time frame: 24 weeks

Sputum IL-8 Levels

Week 24 sputum IL-8 levels in active treatment groups

Time frame: 24 weeks

Sputum GM-CSF Levels

Week 24 sputum GM-CSF levels in active treatment groups were measured.

Time frame: 24 weeks

Sputum IFN-gamma/IL-5 Ratios

Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.

Time frame: 24 weeks

Sputum Eotaxin Levels

Week 24 sputum eotaxin levels in active treatment groups were measured.

Time frame: 24 weeks

Sputum RANTES Levels

Week 24 sputum RANTES levels in active treatment groups were measured.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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