Asthma Bronchiale
Conditions
Keywords
asthma, Tiotropium, Early asthmatic response
Brief summary
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.
Interventions
2 puffs tiotropium prior to allergen challenge
DRUGPlacebo
2 puffs placebo
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * fall in FEV1 of ≥ 20% at a dose of methacholine ≤ 600mcg (methacholine PD20) at Visit 1 * positive response to allergen inhalation challenge (fall in FEV1 of ≥ 15% after inhalation of allergen at a dilution 1:32 or more dillute. * absence of respiratory infection for at least 4 weeks prior to Visit 1 * absence of significant worsening of asthma that requires health care intervention or prolonged change in medication due to allergen exposure (or other trigger) for at least 4 weeks prior to Visit 1 * women of child-bearing potential shall not be pregnant or lactating * non-smoker (cigarettes, vaping); ex-smoker with \<10 pack year history allowed; cannabis use will be evaluated on a case-by-case basis * if on as needed budesonide/formoterol therapy, no reported use within 3 weeks prior to allergen challenge
Exclusion criteria
* Smoker \>10 pack year history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early asthmatic response | 2 hours post-allergen challenge | 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
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory response | Five hours post-allergen challenge | 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 | 30 minutes | 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). |
Countries
Canada
Outcome results
None listed