NCT06679465Not yet recruitingPhase 4
Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
Source: ClinicalTrials.gov · Last updated 7 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 25 Oct 2024
- Start date
- 1 Jan 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- University of Saskatchewan
- Diseases
- Asthma
- NCT number
- NCT06679465
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 10
- From 1 Jan 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Smoker \>10 pack year history
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Saskatchewan Coordinator of this site? Confirm its status | Saskatoon | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.