Back to resultsThe Effects of Montelukast on Smokers With Asthma
Primary Purpose
Asthmatic Smokers, Non-asthmatic Smokers
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluticasone Propionate
Montelukast
Salmeterol
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthmatic Smokers focused on measuring asthmatics, smokers, inhaled corticosteroids, leukotriene receptor antagonists
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
Sites / Locations
- Asthma and Allergy Center, Inje University Sanggye Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
No Intervention
Arm Label
1
2
3
4
5
Arm Description
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
Asthmatic smoker treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months
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
Non-smoking asthmatic treated with Montelukast only: Montelukast dosage: PO 10 mg QHS for 3 months
Normal controls
Outcomes
Primary Outcome Measures
Sputum Neutrophil Percentages
Week 24 sputum neutrophil percentages were measured in active treatment groups.
Secondary Outcome Measures
Sputum Eosinophil Percentages
Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups
Sputum IL-8 Levels
Week 24 sputum IL-8 levels in active treatment groups
Sputum GM-CSF Levels
Week 24 sputum GM-CSF levels in active treatment groups were measured.
Sputum IFN-gamma/IL-5 Ratios
Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.
Sputum Eotaxin Levels
Week 24 sputum eotaxin levels in active treatment groups were measured.
Sputum RANTES Levels
Week 24 sputum RANTES levels in active treatment groups were measured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00712335
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthmatic Smokers, Non-asthmatic Smokers
Keywords
asthmatics, smokers, inhaled corticosteroids, leukotriene receptor antagonists
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Experimental
Arm Description
Asthmatic smoker treated with Montelukast only:
Montelukast dosage: PO 10 mg QHS for 3 months
Arm Title
3
Arm Type
Active Comparator
Arm Description
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
Arm Title
4
Arm Type
Active Comparator
Arm Description
Non-smoking asthmatic treated with Montelukast only:
Montelukast dosage: PO 10 mg QHS for 3 months
Arm Title
5
Arm Type
No Intervention
Arm Description
Normal controls
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Other Intervention Name(s)
inhaled corticosteroid
Intervention Description
DPI 250 mcg BID for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Montelukast
Other Intervention Name(s)
leukotriene receptor antagonist
Intervention Description
PO 10 mg QHS for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Other Intervention Name(s)
long-acting beta-agonist
Intervention Description
DPI 50mg BID for 3 weeks
Primary Outcome Measure Information:
Title
Sputum Neutrophil Percentages
Description
Week 24 sputum neutrophil percentages were measured in active treatment groups.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Sputum Eosinophil Percentages
Description
Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups
Time Frame
24 weeks
Title
Sputum IL-8 Levels
Description
Week 24 sputum IL-8 levels in active treatment groups
Time Frame
24 weeks
Title
Sputum GM-CSF Levels
Description
Week 24 sputum GM-CSF levels in active treatment groups were measured.
Time Frame
24 weeks
Title
Sputum IFN-gamma/IL-5 Ratios
Description
Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.
Time Frame
24 weeks
Title
Sputum Eotaxin Levels
Description
Week 24 sputum eotaxin levels in active treatment groups were measured.
Time Frame
24 weeks
Title
Sputum RANTES Levels
Description
Week 24 sputum RANTES levels in active treatment groups were measured.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Keun Kim, MD, PhD
Organizational Affiliation
Asthma and Allergy Center, Inje University Sanggye Paik Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asthma and Allergy Center, Inje University Sanggye Paik Hospital
City
Seoul
ZIP/Postal Code
139-707
Country
Korea, Republic of
12. IPD Sharing Statement
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The Effects of Montelukast on Smokers With Asthma
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