Allergen Inhalation Challenge for Asthma

(MATT Trial)

Recruiting at 1 trial location

Overseen By Paul Obyrne, MB

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Must not be taking: Asthma medications

Disqualifiers: Respiratory infection, Lung disease, Smoking, others

Compensation: Varies

Number of Visits: 6

Duration: 6 days (3 days per triad with a 4-week washout between allergen and diluent challenges)

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking some asthma medications, as the trial only allows the use of short-acting β2-agonists for asthma treatment. It's best to discuss your current medications with the study team to see if they are allowed.

What data supports the effectiveness of the treatment Allergen challenge, Saline challenge for asthma?

The allergen inhalation challenge is a well-established method for studying asthma and has been shown to help understand how asthma treatments work by inducing and measuring airway responses. It is a reliable tool for evaluating the potential of new asthma therapies, as it can mimic asthma symptoms and test the effectiveness of treatments in a controlled setting. ^{1 2 3 4 5}

Is the allergen inhalation challenge safe for humans?

The allergen inhalation challenge is considered safe when conducted by experienced investigators, and it does not lead to lasting worsening of asthma or changes in airway function. ^{2 4 5 6 7}

How does the allergen inhalation challenge treatment for asthma differ from other treatments?

The allergen inhalation challenge is unique because it involves directly exposing the airways to allergens to study asthma responses, unlike standard treatments that typically aim to prevent or reduce symptoms. This method helps researchers understand the mechanisms of asthma and test new therapies, but it is not a standard treatment for managing asthma symptoms. ^{2 4 8 9 10}

Research Team

Gail Gauvreau, PhD

Principal Investigator

McMaster University

Eligibility Criteria

This trial is for adults aged 18-75 with mild atopic asthma, who can perform required procedures and likely to follow the study plan. They must have a positive skin test for allergens, not exercise before visits, avoid certain asthma medications, and be non-smokers or long-term ex-smokers without significant past smoking history.

Inclusion Criteria

Methacholine provocative concentration causing a 20% fall in forced expiratory volume in 1 second of ≤ 16 mg/ml during the first methacholine inhalation challenge

Forced expiratory volume after 1 second greater than 70% predicted at the first screening visit

Demonstrated (or historic documentation of) early asthmatic response following the allergen inhalation challenge

Exclusion Criteria

Known to have tested positive for human immunodeficiency virus or hepatitis

Reported use of illegal drugs or history of abuse of prescription drugs or alcohol within 1 year before the first screening visit

Inability to produce a sputum sample at the first study visit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inhaled allergen and diluent challenges over two triads, each consisting of 3 consecutive days

6 days (3 days per triad with a 4-week washout between allergen and diluent challenges)

6 visits (in-person)

Washout

A four-week washout period between allergen and diluent inhalation challenges

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Allergen challenge
• Saline challenge

Trial Overview The study tests lung function after inhaling either an allergen or saline (a control substance). It involves measuring changes in breathing and analyzing biological samples to understand inflammation caused by allergens in people with mild allergic asthma.

Participant Groups

Group I: Allergen Challenge Experimental Treatment 1 Intervention

Inhaled allergen

Group II: Diluent Challenge Placebo Group 1 Intervention

Inhaled saline

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Understanding allergic asthma from allergen inhalation tests. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Allergen-induced airway inflammation and its therapeutic intervention. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Reproducibility of allergen-induced early and late asthmatic responses. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Repeatability of allergen-induced airway inflammation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Inhaled allergen bronchoprovocation tests. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

The allergen bronchoprovocation model: an important tool for the investigation of new asthma anti-inflammatory therapies. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Sputum RNA signature in allergic asthmatics following allergen bronchoprovocation test. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Investigative use of fibreoptic bronchoscopy for local airway challenge in asthma. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Repeated high-dose inhalation allergen challenge in asthma. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Novel Blood-based Transcriptional Biomarker Panels Predict the Late-Phase Asthmatic Response. [2019]