Back to results

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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Varenicline

Placebo

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Varenicline

Placebo

Arm Description

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

Placebo tablets equivalent to IMP.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02233231

First Posted

March 18, 2013

Last Updated

January 31, 2020

Sponsor

Vibeke Backer

1. Study Identification

Unique Protocol Identification Number

NCT02233231

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Vibeke Backer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Varenicline

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablets equivalent to IMP.

Intervention Type

Drug

Intervention Name(s)

Varenicline

Other Intervention Name(s)

Placebo

Intervention Description

Varenicline 2 mg x 1 day 7 to week 12

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Varenicline

Intervention Description

similar tabl

Primary Outcome Measure Information:

Title

Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12.

Description

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)

Secondary Outcome Measure Information:

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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: 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. 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. -

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs