Regular Use Tiotropium and Tolerance to Bronchoprotection in Mild Asthma

NCT ID: NCT05113615

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2022-05-06

Brief Summary

The study will assess if regular use of tiotropium (i.e. daily) results in loss of bronchoprotection against methacholine induced bronchoconstriction in those with mild asthma.

Detailed Description

A single dose of an inhaled muscarinic antagonist will protect against methacholine induced bronchoconstriction and increase the dose of methacholine required to cause bronchoconstriction about 4 doubling doses. Beta agonist bronchodilators also shift the dose response curve to the right but the protection against methacholine induced bronchoconstriction is lost (i.e. tolerance develops) with regular use. This study will determine if bronchoprotection is lost following regular use of tiotropium.

This will be a randomized, double-blind placebo controlled study to assess the development of tolerance following regular use of tiotroium in a population of mild asthmatics.

Tiotropium will be administered at the clinically recommended dose (5mcg/day) for a total of 8 days. Methacholine challenges will be performed at baseline (pre-treatment), at one hour post first dose and on day 8, one hour after the final dose. The same will dosing schedule and assessments will occur with an identical placebo inhaler.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tiotropium bromide

tiotropium bromide inhaler (Spiriva Respimat) will be used once daily (2 puffs) for a total of 8 days

Group Type: ACTIVE_COMPARATOR

Tiotropium Bromide

Intervention Type: DRUG

respimat inhaler 2.5mcg/puff

Matching placebo

matching placebo inhaler will be used once daily (2 puffs) for a total of 8 days

Group Type: PLACEBO_COMPARATOR

Matching placebo

Intervention Type: DRUG

matching placebo Respimat inhaler

Interventions

Tiotropium Bromide

respimat inhaler 2.5mcg/puff

Intervention Type: DRUG

Matching placebo

matching placebo Respimat inhaler

Intervention Type: DRUG

Other Intervention Names

Spiriva Respimat

Eligibility Criteria

Inclusion Criteria

• diagnosis of asthma
• asthma is currently well controlled using only occasional bronchodilators
• baseline lung function (FEV1) is greater than 65% of the predicted value
• exhibit bronchoconstriction to inhaled methacholine at a dose of 200mcg or less

Exclusion Criteria

• women who are pregnant or breastfeeding.
• diagnosis of another lung condition or medical condition that would pose a risk to the participant if enrolled in the study
• current smokers of nicotine products (e.g., cigarettes).
• users of cannabis or other inhaled recreational products (e.g., e-cigarettes or other vaping products) on a daily basis
• respiratory infection within 4 weeks of entering the study
• use of any anticholinergic agent within 30 days prior to the beginning of the study (e.g., ipratropium or the study treatment tiotropium).
• known hypersensitivity to tiotropium bromide or components of tiotropium formulation (e.g., benzalkonium chloride), to atropine or its derivatives.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Don Cockcroft

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Don Cockcroft, MD

Role: PRINCIPAL_INVESTIGATOR

University of Saskatchewan

Locations

Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

Bio ID 2985

Identifier Type: -

Identifier Source: org_study_id