Mild AsthmaMATTNCT06411886
Measurements of Inflammation Induced by Allergen Inhalation Challenge in Mild Allergic Asthma
A study testing Allergen challenge and Saline challenge in people with Mild Asthma, run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild Asthma
- What is being tested?
- Allergen challenge and Saline challenge
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jul 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Paul Obyrne, MB contact
Canada2 sites
McMaster Cardio-Respiratory Research Lab
Hamilton, Ontario, L8N 3Z5
McMaster University
Hamilton, Ontario, L8N 3Z5
About this study
Official title: Optimizing the Measurement of Therapeutic Targets for Treatment of Asthma Induced by Allergen Inhalation Challenge in Mild Allergic Asthma
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.
Read the detailed description
This study will measure lung function tests examine biological samples collected before and after inhaled allergen challenges and diluent (control) challenges in participants with mild allergic asthma. Each inhaled challenge will consist of 3 consecutive days (triads) where participants will inhale either allergen extract or saline diluent (control) and airway function will be measured, and biological samples will be obtained. Inhaled allergen challenges will be controlled, with diluent inhalation challenge in a randomized crossover design. Each participant will be required to attend the research lab on at least three consecutive days for an inhaled challenge triad. On triad Day 1, study staff will provide an overview of the study purpose and procedure and answer any questions the participant may have. The individual will then provide informed consent if they wish to participate (i.e. sign the consent form), and safety labs will be collected for blood chemistry and hematology, urinalysis. Skin prick testing will be conducted to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test titration and inhalation. A pre-allergen challenge methacholine test is conducted, followed by sputum induction, blood draw and nasal brushing. On Day 2 of the triad, the participant will inhale a dose of allergen that is 3 doubling doses lower than that estimated (using methacholine test and skin titration) to give a 20% fall in forced expiratory volume in 1 second. The participant will continue inhaling doubling doses of allergen extract until a 20% fall in forced expiratory volume in 1 second has been reached. Spirometry will be performed for 7 hours. At 7h post-inhalation a bronchodilator will be administered, and a sputum sample will be collected. Participants will be sent home with bronchodilator to use if needed. On Day 3 of the triad, participants will return at approximately 24h post-allergen challenge for a methacholine test, sputum induction, blood draw and nasal brushing.
Participants will also undergo a Triad 2 (Days 1-3) for an inhaled challenge with 0.9% saline. The intervention (allergen or diluent) will be randomized to Triad 1 or Triad 2. A four-week washout is required between allergen inhalation and a subsequent diluent inhalation. A one-week washout is required between diluent inhalation and a subsequent allergen inhalation.
- Conditions
- Mild Asthma
- Being tested
- Allergen challenge, Saline challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen challengeDiagnostic test
Inhaled allergen
Saline challengeDiagnostic test
Inhaled saline
| Study group | Role | What they receive |
|---|---|---|
| Allergen Challenge | Experimental | Inhaled allergen Receives: Diagnostic Test: Allergen challenge |
| Diluent Challenge | Placebo comparator | Inhaled saline Receives: Diagnostic Test: Saline challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1
FEV1 after allergen challenge expressed as a percentage of the pre-allergen baseline value.
Measured: 7 hours post-allergen challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild AsthmaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized placebo control two way crossover study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Gauvreau, McMaster University
- Investigators
- Gail Gauvreau, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411886
- Sponsor's protocol ID
- MATT-17085
- Acronym
- MATT
- Status last verified
- May 2024
- First submitted
- 11 Mar 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Measurement of Therapeutic Targets for Treatment of Asthma Induced by Allergen Inhalation Challenge in Mild Allergic Asthma
- ClinicalTrials.gov ID
- NCT06411886
- Acronym / sponsor ID
- MATT / MATT-17085
- Conditions
- Mild Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will measure lung function tests examine biological samples collected before and after inhaled allergen challenges and diluent (control) challenges in participants with mild allergic asthma. Each inhaled challenge will consist of 3 consecutive days (triads) where participants will inhale either allergen extract or saline diluent (control) and airway function will be measured, and biological samples will be obtained. Inhaled allergen challenges will be controlled, with diluent inhalation challenge in a randomized crossover design. Each participant will be required to attend the research lab on at least three consecutive days for an inhaled challenge triad. On triad Day 1, study staff will provide an overview of the study purpose and procedure and answer any questions the participant may have. The individual will then provide informed consent if they wish to participate (i.e. sign the consent form), and safety labs will be collected for blood chemistry and hematology, urinalysis. Skin prick testing will be conducted to determine relevant allergen sensitivities and to determine which allergen extract will be used for the skin test titration and inhalation. A pre-allergen challenge methacholine test is conducted, followed by sputum induction, blood draw and nasal brushing. On Day 2 of the triad, the participant will inhale a dose of allergen that is 3 doubling doses lower than that estimated (using methacholine test and skin titration) to give a 20% fall in forced expiratory volume in 1 second. The participant will continue inhaling doubling doses of allergen extract until a 20% fall in forced expiratory volume in 1 second has been reached. Spirometry will be performed for 7 hours. At 7h post-inhalation a bronchodilator will be administered, and a sputum sample will be collected. Participants will be sent home with bronchodilator to use if needed. On Day 3 of the triad, participants will return at approximately 24h post-allergen challenge for a methacholine test, sputum induction, blood draw and nasal brushing.
Participants will also undergo a Triad 2 (Days 1-3) for an inhaled challenge with 0.9% saline. The intervention (allergen or diluent) will be randomized to Triad 1 or Triad 2. A four-week washout is required between allergen inhalation and a subsequent diluent inhalation. A one-week washout is required between diluent inhalation and a subsequent allergen inhalation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized placebo control two way crossover study
| Arm | Type | Receives |
|---|---|---|
| Allergen Challenge | Experimental | Diagnostic Test: Allergen challengeInhaled allergen |
| Diluent Challenge | Placebo comparator | Diagnostic Test: Saline challengeInhaled saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergen challengeInhaled allergen | Diagnostic test | Allergen Challenge |
| Saline challengeInhaled saline | Diagnostic test | Diluent Challenge |
Primary outcome
Change in FEV1
Time frame: 7 hours post-allergen challenge
FEV1 after allergen challenge expressed as a percentage of the pre-allergen baseline value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Obyrne, MB contact
Gail Gauvreau, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen challenge and Saline challenge in people with Mild Asthma, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gail Gauvreau, PhD (9055259140 ext. 22791, gauvreau@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 (time frame: 7 hours post-allergen challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.