Effect on Fenoterol Metered Dose Inhaler on the Beta-receptor Population on Lymphocytes in Patients With Bronchial Asthma
- Registration Number
- NCT02177370
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The aim of the study was to compare the effect of fenoterol metered dose inhaler with disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population as well as on the clinical findings in patients with bronchial asthma over a two-week period of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
Inclusion Criteria
- sex: male and female
- age: 18 years or over
- bronchial asthma, diagnosis confirmed by history and positive inhalation challenge test (unspecific challenge with carbachol, PD100SRaw))
- severity of asthma mild to moderate or asthmatic in symptom-free intervals
- Raw ≤ 5 cm H2O/l/s
- no antiasthmatic treatment in the week (steroid therapy: two weeks) before the start of the study
Exclusion Criteria
-
clinically significant, concomitant haematological, cardiac, renal, hepatic or metabolic diseases
-
intercurrent diseases, e.g. severe respiratory infections
-
patients who cannot do without the following preparations during the 5-week trial:
- inhaled/oral steroids
- theophylline
- antihistamine, antiallergic drugs
- inhaled/oral sympathomimetics
- anticholinergics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Fenoterol metered dose inhaler (MDI) Fenoterol MDI - DSCG MDI DSCG MDI -
- Primary Outcome Measures
Name Time Method Airway resistance (Raw) after 2 weeks Number of binding sites of the β2 receptors per lymphocytes (BS/LY) after 2 weeks
- Secondary Outcome Measures
Name Time Method