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

NCT ID: NCT02233231

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-05-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

Varenicline 2 mg x 1 day 7 to week 12

Placebo

Placebo tablets equivalent to IMP.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

similar tabl

Interventions

Varenicline

Varenicline 2 mg x 1 day 7 to week 12

Intervention Type: DRUG

Placebo

similar tabl

Intervention Type: DRUG

Other Intervention Names

Placebo; Varenicline

Eligibility Criteria

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.

• 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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vibeke Backer

OTHER

Sponsor Role: lead

Responsible Party

Vibeke Backer

MD, DMSCI

Responsibility Role: SPONSOR_INVESTIGATOR

References

Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type: DERIVED

PMID: 37142273 (View on PubMed)

Other Identifiers

Young smoking asthmatics

Identifier Type: -

Identifier Source: org_study_id