Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Placebo; Drug: Varenicline

• Registration Number: NCT02233231
• Lead Sponsor: Vibeke Backer

Brief Summary

This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.

Detailed Description

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-03-18
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-08
• Last Update Submitted: 2020-01-31
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Asthmatic symptoms during the last year and at least one criterion of the below:

1. current FEV1-increase of minimum 12% after b2-agonist,
2. positiv Methacholintest,
3. Day-to-day FEV1-variation of at least 20% during a two-week period.
4. Positive mannitol test.

Furthermore, all of the below inclusion criteria:

• At least 10 packyears
• At least 10 cigarettes per day within the last year
• Age 18-40 years

Exclusion Criteria

1. Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic corticosteroids, leukotrien-antagonists (LTA), long-lasting b2-agonists, anticholinergic medicine or varenicline within the last 3 months
2. Lower respiratory tract infections, including pneumonia, within the last 6 weeks.
3. Patients suffering from other chronic respiratory disease than asthma, such as sarcoidosis and COPD will also be excluded.
4. Pregnant and nursing women will be excluded as well as women planning pregnancy during the study period.
5. A history of allergy towards study drugs will lead to exclusion.

Patients who during the study period develop lower respiratory infections or due to severe uncontrolled asthma receive treatment with any of the above listed types of medicine will be excluded. Patients who are diagnosed with other chronic respiratory disease than asthma during the study period will also be excluded, as well as patients who during the study period require more asthma medicine than the planned study medication.

Any participant who wishes to leave the study, for any reason, including unacceptable side-effects, during the study period will be excluded, as well as anyone who wants to withdraw their recorded data from the project after the study period has ended.

In case of unacceptable side-effects to varenicline resulting in immediate cessation of treatment with this drug, the participant will continue visits unchanged, but he/she will be excluded from the calculations of tobacco cessation succes-rate. However, varenicline cessation up to 4 weeks after treatment start with varenicline will result in exclusion and replacement of the participant.

Cessation of treatment with budesonide will result in exclusion from the rest the study. The person will not be replaced. The data recorded from the participant until the last visit before cessation will be used.

Allergic reactions towards study drugs will result in immediate cessation of the drug, and possible exclusion, as described in the above.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablets equivalent to IMP.
Varenicline	Varenicline	Varenicline 0,5 mg x 1 day 1-3 Varenicline 0,5 mg x 2 day 4-6 Varenicline 2 mg x 1 day 7 to week 12

Primary Outcome Measures

Name	Time	Method
Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12.	Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks)	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

Secondary Outcome Measures

Name	Time	Method
Change in methacholine hyperresponsiveness by two dosis steps, from baseline (week 0) to week 12.	Time frame for secondary outcome: 0-12 weeks	The secondary outcome are measured at: Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24