Tiotropium Efficacy Against Allergen Induced Early Asthmatic Responses

NCT04648813 | Completed Phase 4

• 1 other identifier: BIO REB 1959
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (1)

• EAR PD20

  amount of inhaled allergen required to induce a 20% fall in FEV1

  30 minutes post last dose of treatment

Secondary Outcomes (2)

• Airway inflammation

  pre-treatment, 30 minutes post final dose and 5 hours post allergen inhalation challenge

• Airway inflammation

  pre treatment and 5 hours post allergen inhalation challenge

Study Arms (2)

tiotropium bromide monohydrate (Spiriva Respimat)

EXPERIMENTAL

Drug: tiotropium bromide monohydrate (Spiriva Respimat)

matching placebo

PLACEBO COMPARATOR

Drug: matching placebo

Interventions

tiotropium bromide monohydrate (Spiriva Respimat) DRUG

administered daily, 2 inhalations/5mcg per dose for a total of 8 doses

tiotropium bromide monohydrate (Spiriva Respimat)

matching placebo DRUG

administered daily, 2 inhalations per dose for a total of 8 doses

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:

• 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

You may not qualify if:

• 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)

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

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: Research Scientist

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 2, 2020
• Study Start: November 13, 2020
• Primary Completion: April 20, 2021
• Study Completion: April 20, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)