Effects of QVAR in Smokers With Asthma
Information source: University Medical Center Groningen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Beclomethasone (QVAR) (Drug); Beclomethasone (Clenil) (Drug); Fluticasone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Medical Center Groningen Official(s) and/or principal investigator(s): Maarten van den Berge, MD, PhD, Principal Investigator, Affiliation: University Medical Center Groningen
Overall contact: Maarten van den Berge, MD, PhD, Phone: +31-50-3615260, Email: m.van.den.berge@umcg.nl
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:
Clinical Details
Official title: Effects Of Extra-fine Particle HFA-becLomethasone (HFA-QVAR) Versus Course Particle Treatment In Smokers and Ex-smokers With Asthma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: PD20 Adenosine
Secondary outcome: Symptoms and PeakflowAirway resistance Spirometry Body Plethysmography Peripheral blood Delta FVC during PD20 small particle adenosine. Questionnaires Multiple Breath Washout Analysis Nasal brushing
Detailed description:
Rationale:
Thus far, most clinical studies investigating the effects of inhaled corticosteroids (ICS)
in asthma have concentrated on non-smoking asthmatics. However, a considerable proportion of
asthma patients smokes. Cigarette smoke consists of ultra-fine particles with a diameter
between 0. 1 and 1 µm and therefore reaches even the smallest airways. In line with this, it
has been reported that smoking is associated with small airways dysfunction. The latter may
help to explain the observation that treatment with course particle inhaled corticosteroids
is less effective in smokers with asthma. Recently, extra-fine particle aerosols such as
hydrofluoroalkane-beclomethasone (HFA-QVAR) have become available for the treatment of
asthma, which are more likely to reach the smaller airways. Based on the above, 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.
Objective: To 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:
Treatment period A: 2-week treatment with HFA-QVAR (TEVA Pharma) 200 μg b. i.d. Treatment
period B: 2-week treatment with HFA-Clenil (Chiesi) 400 μg b. i.d. Treatment period C: 2-week
treatment with HFA-Fluticasone (GlaxoSmithKline) 250 μg b. i.d.
Study population:
20 smokers and 20 ex-smokers with asthma, aged 18-65 years, will receive the following
treatments for two weeks:
Intervention (if applicable):
A: 2-week treatment with HFA-QVAR (TEVA) 200 μg b. i.d. B: 2-week treatment with HFA-Clenil
(Chiesi) 400 μg b. i.d. C: 2-week treatment with HFA-Fluticasone (GlaxoSmithKline) 250 μg
b. i.d.
Main study parameters/endpoints: The primary end-parameter is the decrease in peripheral
airways resistance (R5-R20) at the provocative dose of small particle adenosine causing the
Forced Expiratory Volume in one second (FEV1) to drop with 20%. The co-primary end-parameter
is the PD20 small particle adenosine.
All patients will attend 7 visits to the outpatient clinic. At baseline and after treatment,
the following investigations will be performed: PC20AMP, PD20 small particle adenosine,
spirometry, IOS, body plethysmography, blood collection, filling in of questionnaires, and
nasal epithelial brushings.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Maarten van den Berge, MD, PhD, Phone: +31-50-3615260, Email: m.van.den.berge@umcg.nl
University Medical Center Groningen, Groningen 9713GZ, Netherlands; Recruiting Maarten van den Berge, MD, Phone: +31-50-3616161, Email: m.van.den.berge@umcg.nl Maarten van den Berge, MD, Principal Investigator
Additional Information
Starting date: April 2013
Last updated: January 15, 2015
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