Measurements of Inflammation Induced by Allergen Inhalation Challenge in Mild Allergic Asthma

NCT06411886 | Not Yet Recruiting

• 1 other identifier: MATT-17085
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

This study will measure lung function tests and examine biological samples collected before and after inhaled allergen challenges and diluent (control) challenges in participants with mild allergic asthma.

Conditions

Mild Asthma

Outcome Measures

Primary Outcomes (1)

• Change in FEV1

  FEV1 after allergen challenge expressed as a percentage of the pre-allergen baseline value.

  7 hours post-allergen challenge

Study Arms (2)

Allergen Challenge

EXPERIMENTAL

Inhaled allergen

Diagnostic Test: Allergen challenge

Diluent Challenge

PLACEBO COMPARATOR

Inhaled saline

Diagnostic Test: Saline challenge

Interventions

Allergen challenge DIAGNOSTIC_TEST

Inhaled allergen

Allergen Challenge

Saline challenge DIAGNOSTIC_TEST

Inhaled saline

Diluent Challenge

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 to 75 years inclusive at the first screening visit with mild atopic asthma.
• General good health with no other medical condition, medication use or lifestyle activities that would influence the outcome of the allergen challenge (case by case, investigator discretion)
• A forced expiratory volume after 1 second greater than 70% predicted at the first screening visit.
• A methacholine provocative concentration causing a 20% fall in forced expiratory volume in 1 second of ≤ 16 mg/ml during the first methacholine inhalation challenge.
• Positive skin test to at least one common aeroallergen.
• A demonstrated (or historic documentation of) early asthmatic response following the allergen inhalation challenge.
• Agree to withhold use of inhaled short-acting β2-agonist for 8 hours before all study visits where spirometry is performed.
• Agree to refrain from rigorous exercise 4 hours before all study visits.
• Nonsmoker or former smoker (former smokers are permitted if nonsmoker for 2 years and \<10 pack-year smoking history).
• Capable of performing the maneuvers and procedures required by the protocol and have a high probability for compliance with and completion of the study.

You may not qualify if:

• Upper or lower respiratory infection or asthma exacerbation within 4 weeks of first study visit. The occurrence of allergic rhinitis, as determined by investigator, will not exclude the subject from the study.
• Use of any medications for treatment of asthma other than prophylactic short-acting β2-agonists, or intermittent (not more than once weekly) use of short-acting β2-agonists for relief of symptoms.
• Current or history of lung disease other than mild stable allergic asthma. Smoking within past 12 months, or former smoker with \>10-pack-year history.
• Known to have tested positive for human immunodeficiency virus or hepatitis. For women only - self-reported pregnancy, breast-feeding, or plans to become pregnant during the study.
• Reported use of illegal drugs or history of abuse of prescription drugs or alcohol within 1 year before the first screening visit.
• Any clinically important deviation from normal limits in vital signs.
• Participation in a research study with an investigational product during the last 30 days or 5 half-lives of the drug (whichever is longer) Inability to produce a sputum sample at the first study visit.

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

McMaster Cardio-Respiratory Research Lab

Hamilton, Ontario, L8N 3Z5, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Interventions

Bronchial Provocation Tests

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gail Gauvreau, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail Gauvreau, PhD

CONTACT

9055259140; gauvreau@mcmaster.ca

Paul Obyrne, MB

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized placebo control two way crossover study

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: May 13, 2024
• Study Start: July 1, 2024
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CA (2)