Regular Use Tiotropium and Tolerance to Bronchoprotection in Mild Asthma

NCT05113615 | Completed Phase 4

• 1 other identifier: Bio ID 2985
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

tiotropium; bronchoprotection; tolerance; methacholine PD20

Outcome Measures

Primary Outcomes (3)

• Methacholine PD20

  dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)

  pre treatment

• Methacholine PD20

  dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)

  one hour post first dose

• Methacholine PD20

  dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)

  one hours post final dose

Study Arms (2)

tiotropium bromide

ACTIVE COMPARATOR

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

Drug: Tiotropium Bromide

Matching placebo

PLACEBO COMPARATOR

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

Drug: Matching placebo

Interventions

Tiotropium Bromide DRUG

respimat inhaler 2.5mcg/puff

Also known as: Spiriva Respimat

tiotropium bromide

Matching placebo DRUG

matching placebo Respimat inhaler

Matching placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Don Cockcroft, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: December 13, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)