The effect of tiotropium-bromide on deep inspiration-induced bronchodilation and airway responsiveness in asthma. - Tiotropium-bromide and lung mechanics

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003385-34-NL

Enrollment

Registered

2006-09-28

Start date

2006-11-23

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 70% of predicted). MedDRA version: 8.1 Level: LLT Classification code 10003638 Term: Atopic asthma

Interventions

Trade Name: Spiriva Product Name: tiotropium bromide Product Code: BA 679 BR Pharmaceutical Form: Inhalation powder INN or Proposed INN: TIOTROPIUM BROMIDE CAS Number: 139404481 Current Sponsor code:

Eligibility

Sex/Gender

All

Inclusion criteria

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 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, =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine the effect of 3 weeks of 18mcg tiotropium bromide once daily on the degree of bronchodilation following deep inspiration at a given level of bronchoconstriction. ;Secondary Objective: To examine the effect of 3 weeks of 18mcg tiotropium bromide once daily on the maximal response of the airways to histamine. ;Primary end point(s): M/P ratio at 40% fall in V'40P Resistance of the respiratory system (Rrs) at 8, 12 and 16 Hz during deep inspiration after maximal dose response curve to histamine. Reactance of the respiratory system (Xrs) at 8, 12 and 16 Hz during deep inspiration after maximal dose response curve to histamine. Maximal response to histamine.	—

Measure

Time frame

Main Objective: To examine the effect of 3 weeks of 18mcg tiotropium bromide once daily on the degree of bronchodilation following deep inspiration at a given level of bronchoconstriction. ;Secondary Objective: To examine the effect of 3 weeks of 18mcg tiotropium bromide once daily on the maximal response of the airways to histamine. ;Primary end point(s): M/P ratio at 40% fall in V'40P Resistance of the respiratory system (Rrs) at 8, 12 and 16 Hz during deep inspiration after maximal dose response curve to histamine. Reactance of the respiratory system (Xrs) at 8, 12 and 16 Hz during deep inspiration after maximal dose response curve to histamine. Maximal response to histamine.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026