Asthma and smoking cessation. MedDRA version: 1 Level: LLT Classification code 10003553 Term:
Conditions
Interventions
Trade Name: Champix
Product Name: Champix
Pharmaceutical Form: Tablet
INN or Proposed INN: VARENICLINE
CAS Number: 249296-44-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
Christian Westergaard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In total, 84 asthmatics will be included, in the age of 18-40 years, with at least 10 packyears, and at present current smokers with 10 cigarettes per day within the last 12 months. Inclusion criteria: All asthmatics should at visit 0 or before have symptoms of asthma or signs of reversible airway disease, i.e. a history of reversible airway disease within the last 12 months, assessed by asthma questionaires, or at least one of the following: 1) a current increase of 12% after ?2-agonist, 2) positive methacholine test, 3) positive mannitol test, 4) positive eucapnic hyperventilation test (EVH) or 5) 20% day-to-day FEV1 variation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Asthmatics who have been treated with inhaled corticosteroids (ICS), systemic corticosteroids, leukotrien-antagonists (LTA), long-lasting ?2-agonists, anticholinergic medicine or varenicline within the last 3 months will be excluded, as well as those with 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. Lastly, a history of allergy towards study drugs will lead to exclusion. Patients who during the study period develope lower respiratory infections or due to severe uncontrolled asthma receive treatment with any of the above listed types of medicine will be excluded. Patiens 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 stated in this protocol. Any participant who wishes to 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 results 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 (last visit will be included). Allergic reactions towards study drugs will result in immediate cessation of the drug, and possible exclusion, as described in the above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Research of changes in the asthmatic bronchial inflammation before and after tobacco cessation. Success rate of Champix in young asthmatics.;Secondary Objective: ;Primary end point(s): Changes from eosinophils > 1% or neutrophils > 61% in the sputum to a paucigranulocytic mix with a normal distribution. | — |
Countries
Denmark
Outcome results
None listed