The effect of tiotropium-bromide on deep inspiration-induced bronchodilation and airway responsiveness in asthma. - Tiotropium-bromide and lung mechanics
- Conditions
- 24 patients with mild persistent asthma will participate in the study. All patients will be allergic to one or more airborne allergens, hyperresponsive to histamine (PC20 < 8 mg/ml) and have a normal lung function (FEV1 > 70% of predicted).MedDRA version: 8.1Level: LLTClassification code 10003638Term: Atopic asthma
- Registration Number
- EUCTR2006-003385-34-NL
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 24
Age 18-40
History of episodic symptoms or wheezing, breathlessness, cough or chest tightness (> 12 months)
FEV1 > 70% of predicted
Hyperresponsive in standard histamine challenge (PC20histamine < 8 mg/ml)
Atopic, as reflected by one or more wheal (> 3 mm) and flare responses to skin prick test (SPT) with 10 common airborne allergen extracts (Abelló, ALK Benelux)
Non smoking or ex-smoking (for at least 12 months, < 5 pack years)
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
No usage inhaled corticosteroids for 4 weeks or oral corticosteroids for 3 months prior to and during the study.
No usage of long acting beta2-agonists 24 hours prior to a test and during the study.
No usage of inhaled or oral medication such as antihistamines, ketotifen, sodium chromoglycate, nedocromil sodium, leukotriene receptor antagonists, theophylline, and NSAID's for at least 2 weeks prior to and during the study.
Prohibition of use of short acting beta2-agonists or ipatropium bromide 8 hours prior to a test.
No history of respiratory tract infection, or relevant allergen exposure during 2 weeks prior to the study.
No known other pulmonary abnormalities or cardiovascular diseases.
No acute illness.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method