Effects of QVAR in Smokers With Asthma

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

We hypothesize that extra-fine particle treatment with HFA-QVAR will be superior in improving small airways dysfunction, especially in ex-smokers and smokers with asthma.

To investigate this, we will perform a study comparing the efficacy of extra-fine particle HFA-QVAR 200 µg b.i.d. to an equipotent dose of course particle HFA-beclomethasone (HFA-Clenil) 400 µg b.i.d. and with coarse particle HFA-fluticasone (GSK) 250 µg in ex-smokers and smokers with asthma.

Study design: This study will be an open-label, randomised, three-way cross-over, two-center study. 20 smokers and 20 ex-smokers with asthma will receive the following treatments for two weeks:

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Teva Pharma
• Treatments: Beclomethasone; Fluticasone

Criteria

3.1 Inclusion criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

• Males and females with a doctor's diagnosis of asthma

• Age between 18 and 65 years

• Current- and ex-smokers with ≥ 5 packyears.

• Drop in FEV1 > 20% after provocation with small particle adenosine < 20 mg at visit 1.

3.2 Exclusion criteria

A subject who meets any of the following criteria will be excluded from participation in this study:

• An asthma exacerbation during the last 6 weeks or upper respiration tract infection during the last 4 weeks prior to inclusion in the study.

• Severe airway obstruction at baseline, FEV1 < 50% of predicted or < 1.2 liter.

• Physician diagnosed predominant COPD or any other pulmonary disease that could influence the study results as judged by the investigator.

• Pregnant or lactating women.

• Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or the use of one or more of the following acceptable methods of contraception:

1. Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).

2. Hormonal contraception (implantable, patch, oral, injectable).

3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.

4. Continuous abstinence. Periodic abstinence (e.g. calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.