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The Effects of Montelukast on Smokers With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00712335
Recruitment Status : Completed
First Posted : July 9, 2008
Results First Posted : May 16, 2012
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):
Chang-Keun Kim, Dr., Inje University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asthmatic Smokers Non-asthmatic Smokers Drug: Fluticasone Propionate Drug: Montelukast Drug: Salmeterol Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma
Study Start Date : February 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

Arms and Interventions
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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 Name: inhaled corticosteroid

Drug: Salmeterol
DPI 50mg BID for 3 weeks
Other Name: 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 Name: 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 Name: inhaled corticosteroid

Drug: Salmeterol
DPI 50mg BID for 3 weeks
Other Name: 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 Name: leukotriene receptor antagonist
No Intervention: 5
Normal controls


Outcome Measures
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Primary Outcome Measures :
  1. Sputum Neutrophil Percentages [ Time Frame: 24 weeks ]
    Week 24 sputum neutrophil percentages were measured in active treatment groups.


Secondary Outcome Measures :
  1. Sputum Eosinophil Percentages [ Time Frame: 24 weeks ]
    Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups

  2. Sputum IL-8 Levels [ Time Frame: 24 weeks ]
    Week 24 sputum IL-8 levels in active treatment groups

  3. Sputum GM-CSF Levels [ Time Frame: 24 weeks ]
    Week 24 sputum GM-CSF levels in active treatment groups were measured.

  4. Sputum IFN-gamma/IL-5 Ratios [ Time Frame: 24 weeks ]
    Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.

  5. Sputum Eotaxin Levels [ Time Frame: 24 weeks ]
    Week 24 sputum eotaxin levels in active treatment groups were measured.

  6. Sputum RANTES Levels [ Time Frame: 24 weeks ]
    Week 24 sputum RANTES levels in active treatment groups were measured.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712335


Locations
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Korea, Republic of
Asthma and Allergy Center, Inje University Sanggye Paik Hospital
Seoul, Korea, Republic of, 139-707
Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Chang-Keun Kim, MD, PhD Asthma and Allergy Center, Inje University Sanggye Paik Hospital
More Information
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Responsible Party: Chang-Keun Kim, Dr., Director, Asthma and Allergy Center; Chairman of Pediatrics; Professor of Pediatrics, Inje University
ClinicalTrials.gov Identifier: NCT00712335    
Other Study ID Numbers: MASK2008
First Posted: July 9, 2008    Key Record Dates
Results First Posted: May 16, 2012
Last Update Posted: May 16, 2012
Last Verified: April 2012
Keywords provided by Chang-Keun Kim, Dr., Inje University:
asthmatics
smokers
inhaled corticosteroids
leukotriene receptor antagonists
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Xhance
Salmeterol Xinafoate
Montelukast
Leukotriene Antagonists
Anti-Inflammatory Agents
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists