The Effects of Montelukast on Smokers With Asthma

NCT ID: NCT00712335

Last Updated: 2012-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2011-05-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1

Asthmatic smokers treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months

Group Type: EXPERIMENTAL

Fluticasone Propionate

Intervention Type: DRUG

DPI 250 mcg BID for 3 weeks

Salmeterol

Intervention Type: DRUG

DPI 50mg BID for 3 weeks

2

Asthmatic smoker treated with Montelukast only:

Montelukast dosage: PO 10 mg QHS for 3 months

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: DRUG

PO 10 mg QHS for 3 weeks

3

Non-smoking asthmatics treated with combination therapy:

Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type: DRUG

DPI 250 mcg BID for 3 weeks

Salmeterol

Intervention Type: DRUG

DPI 50mg BID for 3 weeks

4

Non-smoking asthmatic treated with Montelukast only:

Montelukast dosage: PO 10 mg QHS for 3 months

Group Type: ACTIVE_COMPARATOR

Montelukast

Intervention Type: DRUG

PO 10 mg QHS for 3 weeks

5

Normal controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Fluticasone Propionate

DPI 250 mcg BID for 3 weeks

Intervention Type: DRUG

Montelukast

PO 10 mg QHS for 3 weeks

Intervention Type: DRUG

Salmeterol

DPI 50mg BID for 3 weeks

Intervention Type: DRUG

Other Intervention Names

inhaled corticosteroid; leukotriene receptor antagonist; long-acting beta-agonist

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inje University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Keun Kim, Dr.

Director, Asthma and Allergy Center; Chairman of Pediatrics; Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang-Keun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asthma and Allergy Center, Inje University Sanggye Paik Hospital

Locations

Asthma and Allergy Center, Inje University Sanggye Paik Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

MASK2008

Identifier Type: -

Identifier Source: org_study_id