Tests a single dose of tiotropium in adults with asthma exposed to allergens
Tests one dose of tiotropium against placebo in adults with asthma during allergen challenge.
Plain-language title generated from the registry record
Registry title: Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
Key facts
- Where
- Saskatoon, CanadaSee the site
- Phase
- Phase 4
Where in Canada
- University of SaskatchewanSaskatoon, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Saskatchewan
- Trial code
- NCT06679465
- Record updated
- 7 November 2024
- Original description
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.Read full original descriptionShow less
Evaluating the Impact of Single Dose Tiotropium on Allergen-induced 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.
Inclusion: 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: Smoker >10 pack year history.