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

Phase 4

Not yet recruiting

• Conditions: Asthma Bronchiale
• Interventions: Drug: Tiotropium (Spiriva®); Drug: Placebo

• Registration Number: NCT06679465
• Lead Sponsor: University of Saskatchewan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Study Start: 2025-01-01
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tiotropium treatment	Tiotropium (Spiriva®)	2 puffs tiotropium
Placebo	Placebo	2 puffs placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada