NCT04648813

Tiotropium Efficacy Against Allergen Induced Early Asthmatic Responses

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will compare the effect of inhaled tiotropium versus placebo on allergen induced early asthmatic responses in individuals with atopic asthma.

Detailed description

This is a single center, double-blind, randomized, placebo-controlled, crossover study. The study will consist of two one week treatment periods, one with tiotropium (two inhalations/5mcg/day) and one with placebo (2inhalations/day). A minimum two week washout period between treatments is required. Four visits over the course of approximately 4 weeks will be required to complete the study. Procedures at each visit are as follows: Visit 1: Participants will undergo consent procedures and if consent is provided measurements of FeNO, spirometry, airway responsiveness to methacholine, skin prick testing, skin titration endpoint testing and sputum induction will be performed. If participants meet eligibility criteria following these assessments, treatment 1 will be dispensed and the first dose administered. The participant will then self administer the treatment for the next six days (i.e. a total of 7 days of treatment) before returning for Visit 2. Visit 2: A final dose of treatment 1 will be administered. At 30 minutes post dose, FeNO testing, spirometry measurements and allergen inhalation challenge will be performed. Five hours after the allergen challenge, FeNO will again be measured and sputum induction will be performed. Visits 3 and 4: Visits 3 and 4 will be identical to Visit 1 and 2 except that no skin prick testing or skin titration endpoint testing will be required. At Visit 3 participants will be crossed over to treatment 2 and the first dose will be administered. Participants will self administer treatment 2 for the next six days before returning for Visit 4. The primary endpoint will be the EAR PD20, the amount of allergen required to induce an early asthmatic response (i.e. a fall in FEV1 post allergen inhalation of 20% or more) tiotropium versus placebo.

Conditions

• Allergic Asthma

Interventions

Type	Name	Description
DRUG	tiotropium bromide monohydrate (Spiriva Respimat)	administered daily, 2 inhalations/5mcg per dose for a total of 8 doses
DRUG	matching placebo	administered daily, 2 inhalations per dose for a total of 8 doses

Timeline

• Start date: 2020-11-13
• Primary completion: 2021-04-20
• Completion: 2021-04-20
• First posted: 2020-12-02
• Last updated: 2021-09-30

Locations

1 site across 1 country: Canada