AsthmaPhase 4NCT02233231
Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
A Phase 4 study testing Varenicline in people with Asthma, run by Vibeke Backer.
Trial summary
This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Asthma
- What is being tested?
- Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to May 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
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- At least 10 packyears
- At least 10 cigarettes per day within the last year
- Age 18-40 years
Who cannot join
- 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.
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- 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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About this study
This is a study describing changes in inflammation of the airways in asthmatics before and after smoking cessation and steroid treatment.
Read the 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
- Being tested
- Varenicline, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Placebo
Varenicline 2 mg x 1 day 7 to week 12
PlaceboDrug
Also called Varenicline
similar tabl
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Varenicline |
| Placebo | Placebo comparator | Placebo tablets equivalent to IMP. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
The secondary outcome are measured at:
Visit 1: Week 0, Visit 2: Week 6, Visit 3: Week 12, Visit 4: Week 24
Measured: Time frame for secondary outcome: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vibeke Backer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vibeke Backer, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233231
- Sponsor's protocol ID
- Young smoking asthmatics
- Status last verified
- Sep 2014
- First submitted
- 18 Mar 2013
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37142273
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
- ClinicalTrials.gov ID
- NCT02233231
- Acronym / sponsor ID
- Young smoking asthmatics
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Vibeke BackerUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline | Active comparator | Drug: VareniclineVarenicline 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 | Placebo comparator | Drug: PlaceboPlacebo tablets equivalent to IMP. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: PlaceboVarenicline 2 mg x 1 day 7 to week 12 | Drug | Varenicline |
| PlaceboAlso: Vareniclinesimilar tabl | Drug | Placebo |
Primary outcome
Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12.
Time frame: 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
1 secondary outcome
Change in methacholine hyperresponsiveness by two dosis steps, from baseline (week 0) to week 12.
Time frame: Time frame for secondary outcome: 0-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 37142273Livingstone-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Varenicline in people with Asthma, run by Vibeke Backer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (time frame: Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02233231, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.