The Effects of Montelukast on Smokers With Asthma

April 18, 2012 updated by: Chang-Keun Kim, Dr., Inje University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 139-707
        • Asthma and Allergy Center, Inje University Sanggye Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Fluticasone Propionate
DPI 250 mcg BID for 3 weeks
Other Names:
  • inhaled corticosteroid
Drug: Salmeterol
DPI 50mg BID for 3 weeks
Other Names:
  • long-acting beta-agonist
Experimental: 2

Asthmatic smoker treated with Montelukast only:

Montelukast dosage: PO 10 mg QHS for 3 months
Drug: Montelukast
PO 10 mg QHS for 3 weeks
Other Names:
  • leukotriene receptor antagonist
Active Comparator: 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
Drug: Fluticasone Propionate
DPI 250 mcg BID for 3 weeks
Other Names:
  • inhaled corticosteroid
Drug: Salmeterol
DPI 50mg BID for 3 weeks
Other Names:
  • long-acting beta-agonist
Active Comparator: 4

Non-smoking asthmatic treated with Montelukast only:

Montelukast dosage: PO 10 mg QHS for 3 months
Drug: Montelukast
PO 10 mg QHS for 3 weeks
Other Names:
  • leukotriene receptor antagonist
No Intervention: 5
Normal controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum Neutrophil Percentages
Time Frame: 24 weeks
Week 24 sputum neutrophil percentages were measured in active treatment groups.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum Eosinophil Percentages
Time Frame: 24 weeks
Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups
24 weeks
Sputum IL-8 Levels
Time Frame: 24 weeks
Week 24 sputum IL-8 levels in active treatment groups
24 weeks
Sputum GM-CSF Levels
Time Frame: 24 weeks
Week 24 sputum GM-CSF levels in active treatment groups were measured.
24 weeks
Sputum IFN-gamma/IL-5 Ratios
Time Frame: 24 weeks
Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.
24 weeks
Sputum Eotaxin Levels
Time Frame: 24 weeks
Week 24 sputum eotaxin levels in active treatment groups were measured.
24 weeks
Sputum RANTES Levels
Time Frame: 24 weeks
Week 24 sputum RANTES levels in active treatment groups were measured.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Principal Investigator: Chang-Keun Kim, MD, PhD, Asthma and Allergy Center, Inje University Sanggye Paik Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 7, 2008

First Posted (Estimate)

July 9, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MASK2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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