E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003638 |
E.1.2 | Term | Atopic asthma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
To examine the effect of 3 weeks of 18mcg tiotropium bromide once daily on the maximal response of the airways to histamine.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
pathophysiology of asthma |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends when 24 patients have completed all study tests. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |