The Effects of Montelukast on Smokers With Asthma | RxWiki

The Effects of Montelukast on Smokers With Asthma

Overview[ - collapse ][ - ]

Purpose	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	Asthmatic Smokers Non-asthmatic Smokers
Intervention	Drug: Fluticasone Propionate Drug: Montelukast Drug: Salmeterol
Phase	Phase 4
Sponsor	Inje University
Responsible Party	Inje University
ClinicalTrials.gov Identifier	NCT00712335
First Received	July 7, 2008
Last Updated	April 18, 2012
Last verified	April 2012

Tracking Information[ + expand ][ + ]

First Received Date	July 7, 2008
Last Updated Date	April 18, 2012
Start Date	February 2007
Estimated Primary Completion Date	May 2011
Current Primary Outcome Measures	Sputum Neutrophil Percentages [Time Frame: 24 weeks] [Designated as safety issue: No]Week 24 sputum neutrophil percentages were measured in active treatment groups.
Current Secondary Outcome Measures	Sputum Eosinophil Percentages [Time Frame: 24 weeks] [Designated as safety issue: No]Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups Sputum IL-8 Levels [Time Frame: 24 weeks] [Designated as safety issue: No]Week 24 sputum IL-8 levels in active treatment groups Sputum GM-CSF Levels [Time Frame: 24 weeks] [Designated as safety issue: No]Week 24 sputum GM-CSF levels in active treatment groups were measured. Sputum IFN-gamma/IL-5 Ratios [Time Frame: 24 weeks] [Designated as safety issue: No]Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups. Sputum Eotaxin Levels [Time Frame: 24 weeks] [Designated as safety issue: No]Week 24 sputum eotaxin levels in active treatment groups were measured. Sputum RANTES Levels [Time Frame: 24 weeks] [Designated as safety issue: No]Week 24 sputum RANTES levels in active treatment groups were measured.

Descriptive Information[ + expand ][ + ]

Brief Title	The Effects of Montelukast on Smokers With Asthma
Official Title	The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Condition	Asthmatic Smokers Non-asthmatic Smokers
Intervention	Drug: Fluticasone Propionate DPI 250 mcg BID for 3 weeks Other Names: inhaled corticosteroidDrug: Montelukast PO 10 mg QHS for 3 weeks Other Names: leukotriene receptor antagonistDrug: Salmeterol DPI 50mg BID for 3 weeks Other Names: long-acting beta-agonist
Study Arm (s)	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 Experimental: 2 Asthmatic smoker treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months 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 Active Comparator: 4 Non-smoking asthmatic treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months No Intervention: 5 Normal controls

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	105
Estimated Completion Date	May 2011
Estimated Primary Completion Date	May 2011
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT00712335
Other Study ID Numbers	MASK2008
Has Data Monitoring Committee	Yes
Information Provided By	Inje University
Study Sponsor	Inje University
Collaborators	Not Provided
Investigators	Principal Investigator: Chang-Keun Kim, MD, PhD Asthma and Allergy Center, Inje University Sanggye Paik Hospital
Verification Date	April 2012

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