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

NCT02233231 | Completed Phase 4 DMC

• 1 other identifier: Young smoking asthmatics
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 for primary outcome: 0-12 weeks (total study duration 24 weeks)

Secondary Outcomes (1)

• Change in methacholine hyperresponsiveness by two dosis steps, from baseline (week 0) to week 12.

  Time frame for secondary outcome: 0-12 weeks

Study Arms (2)

Varenicline

ACTIVE COMPARATOR

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

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Placebo tablets equivalent to IMP.

Drug: Placebo

Interventions

Varenicline DRUG

Varenicline 2 mg x 1 day 7 to week 12

Also known as: Placebo

Varenicline

Placebo DRUG

similar tabl

Also known as: Varenicline

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Asthmatic symptoms during the last year and at least one criterion of the below:
• current FEV1-increase of minimum 12% after b2-agonist,
• positiv Methacholintest,
• Day-to-day FEV1-variation of at least 20% during a two-week period.
• Positive mannitol test.
• At least 10 packyears
• At least 10 cigarettes per day within the last year
• Age 18-40 years

You may not qualify if:

• 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
• Lower respiratory tract infections, including pneumonia, within the last 6 weeks.
• Patients suffering from other chronic respiratory disease than asthma, such as sarcoidosis and COPD will also be excluded.
• Pregnant and nursing women will be excluded as well as women planning pregnancy during the study period.
• 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.

Sponsors & Collaborators

• Vibeke Backer: lead

Related Publications (1)

• 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.

  PMID: 37142273 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, DMSCI

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: September 8, 2014
• Study Start: August 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 5, 2020

Record last verified: 2014-09