The Effects of Montelukast on Smokers With Asthma - Full Text View

Sponsored by:	Inje University
Information provided by:	Inje University
ClinicalTrials.gov Identifier:	NCT00712335

Purpose

To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers.
To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.

Condition	Intervention	Phase
Asthmatic Smokers Non-Asthmatic Smokers	Drug: fluticasone propionate Drug: fluticasone propionate (FP) and salmeterol Drug: montelukast Drug: fluticasone propionate and salmeterol Drug: Montelukast	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Corticosteroids Fluticasone Fluticasone propionate Montelukast sodium Montelukast Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Parallel Assignment, Pharmacodynamics Study
Official Title:	The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma

Further study details as provided by Inje University:

Primary Outcome Measures:

Sputum neutrophil counts [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sputum cells, eosinophil and urinary markers,neutrophils, and Th1/Th2 cytokines [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Asthmatic smoker treated with inhaled corticosteroids	Drug: fluticasone propionate dry powder inhaler (DPI)250mcg BID for 3 weeks
2: Experimental Asthmatic smokers treated with combination therapy	Drug: fluticasone propionate (FP) and salmeterol FP: DPI 250 mcg BID for 3 weeks S: DPI 50 mcg BID for 3 weeks
3: Experimental Asthmatic smoker treated with Montelukast only	Drug: montelukast PO 10 mg QHS for 3 weeks
4: Active Comparator Asthmatic non-smoker treated with inhaled corticosteroid	Drug: fluticasone propionate DPI 250mcg BID for 3 weeks
5: Active Comparator Non-smoking asthmatic treated with combination therapy	Drug: fluticasone propionate and salmeterol FP: DPI 250mcg for 3 weeks S: DPI 50mg BID for 3 weeks
6: Active Comparator Non-smoking asthmatic treated with Montelukast only	Drug: Montelukast PO 10 mg QHS for 3 weeks
7: No Intervention Normal controls

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712335

Contacts

Contact: Dr. Chang-Keun Kim, MD, PhD

82-2-950-8832

kimck@paik.ac.kr

Locations

Korea, Republic of
Asthma and Allergy Center, Inje University Sanggye Paik Hospital	Recruiting
Seoul, Korea, Republic of, 139-707
Contact: Chang-Keun Kim kimck@paik.ac.kr
Principal Investigator: Chang-Keun Kim, MD, PhD

Sponsors and Collaborators

Inje University

Investigators

Principal Investigator:

Chang-Keun Kim, MD, PhD

Asthma and Allergy Center, Inje University Sanggye Paik Hospital

More Information

Responsible Party:	Asthma and Allergy Center, Inje University Sanggye Paik Hospital ( Dr. Chang-Keun Kim )
Study ID Numbers:	MASK2008
Study First Received:	July 7, 2008
Last Updated:	July 7, 2008
ClinicalTrials.gov Identifier:	NCT00712335
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Inje University:

asthmatics
smokers
inhaled corticosteroids
leukotriene receptor antagonists

Study placed in the following topic categories:

Montelukast
Salmeterol
Fluticasone
Asthma
Leukotriene Antagonists

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Anti-Allergic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009