Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06679465 | NOT YET RECRUITING | Asthma Bronchiale

Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
Sponsor:

University of Saskatchewan

Information provided by (Responsible Party):

Brianne Philipenko

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.

Condition or disease

Bronchial Asthma

Intervention/treatment

Tiotropium (Spiriva®)

Placebo

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
Actual Study Start Date : 2025-01-01
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response

Location Details

NCT06679465

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Canada, Saskatchewan

University of Saskatchewan

Saskatoon, Saskatchewan, Canada, S7M 2W2