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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma Bronchiale
• Intervention / Treatment: Drug: Tiotropium (Spiriva®); Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7M 2W2
      • University of Saskatchewan
      • Contact: Brianne Philipenko, MD; Phone Number: 4 306-956-3444; Email: bsp943@mail.usask.ca
      • Contact: Brianne Philipenko, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tiotropium treatment; 2 puffs tiotropium	Drug: Tiotropium (Spiriva®); 2 puffs tiotropium prior to allergen challenge
Placebo Comparator: Placebo; 2 puffs placebo	Drug: Placebo; 2 puffs placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early asthmatic response	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.	2 hours post-allergen challenge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory response	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.	Five hours post-allergen challenge
FEV1	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).	30 minutes

Collaborators and Investigators

• Sponsor: University of Saskatchewan

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: asthma; Tiotropium; Early asthmatic response
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Tiotropium Bromide
• Other Study ID Numbers: 5080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes