Tiotropium Efficacy Against Allergen Induced Early Asthmatic Responses

• Status: Completed
• Trial end date: 2021-04-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Treatments: Bromides; Tiotropium Bromide

Criteria

Inclusion Criteria:

• signed informed consent

• diagnosis of mild asthma with a minimum 3 months history at the time of enrolment into the trial

• pre-bronchodilator FEV1 80% or greater than the predicted value

• positive response to inhaled methacholine (i.e. MCh PD20 ≤ 400mcg)

• evidence of atopy (i.e. positive skin prick test to an allergen that is appropriate for use in allergen inhalation challenge)

• no respiratory infection within 4 weeks of Visit 1

• no allergen exposure within 4 weeks of Visit 1

• current non-smoker (ex-nicotine smoker with < 10 pack years evaluated case by case)

• use of β2 agonist rescue medications less than daily and no more than 4 times per week

• general good health with no other medical condition, medication use or lifestyle activities that would potentially alter the outcome of the allergen challenge

Exclusion Criteria:

• currently pregnant or breast-feeding

• current daily use of other inhaled recreational products (e.g. cannabis, e-cigarettes or other vaping products; occasional use requires 24 hour withhold)

• diagnosis or evidence of narrow angle glaucoma

• diagnosis or evidence of urinary retention

• known hypersensitivity to tiotropium, atropine or its derivatives (e.g. ipratropium) or components of tiotropium formulation (e.g. benzalkonium chloride)

• history of anaphylaxis or angioedema

• current use of :

• inhaled corticosteroid including combination therapies

• inhaled muscarinic antagonists - except study treatment (e.g. ipratropium bromide)

• long-acting beta2-agonists (LABA; e.g. formoterol)

• leukotriene receptor antagonists (e.g. montelukast)

• biologics (e.g. benralizumab)

• allergen immunotherapy

• mast cell stabilizers (e.g. nedocromil sodium)