About this trial
Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age (years) at least 18 years
no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator)
baseline FEV1 ≥ 65% of predicted normal at Visit 1
evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse
Disqualifiers
Smoker >10 pack year history
Trial design
Crossover
Treatments tested in this trial
Tiotropium (Spiriva®)
Drug2 puffs tiotropium prior to allergen challenge
Placebo
Drug2 puffs placebo
Treatment groups
Trial outcomes
Primary outcomes
Early asthmatic response
Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.
Secondary outcomes
Inflammatory response
1\. Evaluate effect of single dose tiotropium versus single dose matched placebo on airway inflammation five hours after allergen challenge through analyses of sputum eosinophil counts, and cytokine analysis including IL-4, 5, 13 and TSLP.
FEV1
2\. Evaluate bronchodilating effect of single dose tiotropium versus placebo on baseline lung function by comparing maximal FEV1 pre versus 30 minutes post treatment (i.e. prior to allergen challenge).
Sponsors and contacts
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