This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.
84 smoking asthmatics will be included. 50% will be treated with varenicline and 50% with placebo tablets for 12 weeks. All will be treated with inhaled steroid for 12 weeks. Study period: About 26 weeks including asthma screening. 4 visits will be performed. Inflammation will be described through sputum induction, and several other pulmonary medical tests will be performed, including NO, methacholine, spirometry, CO, blood samples, skin prick test and asthma questionaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
Varenicline 2 mg x 1 day 7 to week 12
similar tabl
Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12.
Power calculations are based on changes during 0-12 weeks. The total study includes primary outcome measurements at: Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24
Time frame: Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks)
Change in methacholine hyperresponsiveness by two dosis steps, from baseline (week 0) to week 12.
The secondary outcome are measured at: Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24
Time frame: Time frame for secondary outcome: 0-12 weeks
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