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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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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