Phase 4
N=105
The Effects of Montelukast on Smokers With Asthma
Asthmatic Smokers · Non-asthmatic Smokers
Bottom Line
View on ClinicalTrials.gov: NCT00712335 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: Sputum Neutrophil Percentages — 86.00; 72.53; 89.33; 79.84 percentage of neutrophils
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fluticasone Propionate (Drug); Montelukast (Drug); Salmeterol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inje University
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sputum Neutrophil Percentages |
86.00; 72.53; 89.33; 79.84 | — |
| SECONDARY Sputum Eosinophil Percentages |
2.33; 3.60; 1.60; 3.26 | — |
| SECONDARY Sputum IL-8 Levels |
334545; 26,300; 3602; 317778 | — |
| SECONDARY Sputum GM-CSF Levels |
17.60; 15.18; 13.92; 12.16 | — |
| SECONDARY Sputum IFN-gamma/IL-5 Ratios |
627.4; 272.4; 183.8; 279.0 | — |
| SECONDARY Sputum Eotaxin Levels |
47.13; 87.90; 65.14; 64.61 | — |
| SECONDARY Sputum RANTES Levels |
42.79; 44.03; 41.78; 36.41 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00712335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.