Asthma, AllergicPhase 2NCT05740748
Tezepelumab and Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma
A Phase 2 study testing Tezepelumab in people with Asthma, Allergic, run by McMaster University at 2 sites in Canada.
Trial summary
Asthma is a condition where small inhaled particles can cause inflammation in the lung leading to constriction of airways and wheeze. Mast cells are immune cells in airways that can release chemical causing constriction of the airways and wheeze. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Allergic
- What is being tested?
- Tezepelumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Apr 2023to 30 Dec 2024
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Male and female 18 through 65 years of age
- Positive skin-prick test to a common aeroallergen
- Methacholine PD20 ≤ 200mcg
- Mannitol DRR ≤ 42.3mg/FEV1 %f all (equivalent to PD15 ≤ 635mg)
- Baseline FEV1 ≥ 70% of the predicted value
- Negative pregnancy test (urine) for female participants of childbearing potential.
Who cannot join
- Current or former smoker with >10-pack-year history
- Current or previous history of lung disease other than mild stable allergic asthma
- Significant systemic disease, including history of current malignancy or autoimmune disease
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previous randomisation in the present study. Re-screening (Week -1) for FEV1 and AHR is permitted once for each test.
- Participation in another clinical study with an investigational product during the last 30 days or 5 half-lives of the drug (whichever is longer)
Show all 13Show fewer
- Use of any medications for treatment of asthma other than prophylactic short-acting β2-agonists, or use of short-acting β2-agonists for relief of symptoms less than once weekly.
- Participants with known hypersensitivity to tezepelumab or any of the excipients of the product.
- Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening
- Known to have tested positive for human immunodeficiency virus
- Known history of drug or alcohol abuse within 1 year of screening
- For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
- Unwillingness or inability to comply with the study protocol for any other reason.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8N 3Z5
Gail M Gauvreau, PhD, 9055259140 ext. 22791, gauvreau@mcmaster.ca
Paul M O'Byrne, MB, 9055259140 ext. 22100, obyrne@mcmaster.ca
University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
Beth Davis, PhD, (306) 844-1444, beth.davis@usask.ca
Donald Cockcroft, MD, (306) 844-1444, don.cockcroft@usask.ca
About this study
Official title: A Phase 2 Multi-centre Randomized Double-blind Placebo-controlled Parallel Group Study to Examine the Effects of 24 Weeks Tezepelumab 210 mg sc q4wks on Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma
Asthma is a condition where small inhaled particles can cause inflammation in the lung leading to constriction of airways and wheeze. Mast cells are immune cells in airways that can release chemical causing constriction of the airways and wheeze. Tezepelumab is an injectable medication that improves asthma by stopping inflammation, but the effect on mast cells is not known. Tezepelumab was approved in Canada July 2022 for treatment of severe asthma. Tezepelumab is not approved for treatment of mild asthma by any health authority, except for use in research studies like this. This study will examine the effect of tezepelumab on mast cells and airway constriction to understand the mechanisms of asthma, and which patients will benefit most from drugs like tezepelumab.
Read the detailed description
The proposed study will address whether tezepelumab has the unique ability to improve AHR in participants with mild allergic asthma.
This is a phase 2 multi-centre randomized double-blind placebo-controlled parallel-group study to examine the effects of 24 weeks tezepelumab 210 mg sc q4wks on methacholine airway hyperresponsiveness in participants with mild allergic asthma, stratified for sex and sensitivity to seasonal allergens.
There are 9 study visits over a period of 27 weeks (Figure 1). Study procedures performed at Weeks -1, 8, 16 and 24 will be divided across 2 visits at least 48 hours apart for measurement of AHR to methacholine first, and mannitol at least 48 hours later.
The screening period at Week -1 will determine eligibility. At Week -1, eligible allergic mild asthmatic participants will be randomized 1:1 to placebo or tezepelumab 210 mg subcutaneous administered monthly for a total of 24 weeks. AHR will be measured by methacholine and mannitol challenges at baseline (Week -1) performed at least 48 hours apart. Changes in AHR response will be measured by repeat methacholine and mannitol challenges at Weeks 8, 16 and 24.
- Conditions
- Asthma, Allergic
- Being tested
- Tezepelumab, Placebo
- Keywords
- asthma, airway hyperresponsiveness, mast cell, Thymic stromal lymphopoietin, tezepelumab
- Medical subject headings
- Asthma, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabDrug
tezepelumab 210 mg sc q4wks for 20 weeks
PlaceboDrug
placebo sc q4wks for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab | Experimental | tezepelumab 210 mg sc q4wks 20 weeks treatment Receives: Drug: Tezepelumab |
| Placebo | Placebo comparator | placebo sc q4wks 20 weeks treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine PD20
The provocative dose of methacholine causing 20% fall in FEV1
Measured: Week -1 to Week 24
Secondary outcomes (2)
Dose response ratio to mannitol
The mannitol dose response ratio calculated by dividing the total cumulative dose by the % fall in FEV1 at that dose.
Measured: Week -1 to Week 24
Mast cell tryptase levels.
Level of mast cell-derived tryptase in blood and urine at Week 24.
Measured: Week -1 to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Apr 2023 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, AllergicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Saskatchewan
- Responsible party
- Sponsor
- Investigators
- Gail Gauvreau, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740748
- Sponsor's protocol ID
- ESR-22-21828
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-centre Randomized Double-blind Placebo-controlled Parallel Group Study to Examine the Effects of 24 Weeks Tezepelumab 210 mg sc q4wks on Methacholine Airway Hyperresponsiveness in Participants With Mild Allergic Asthma
- ClinicalTrials.gov ID
- NCT05740748
- Acronym / sponsor ID
- ESR-22-21828
- Conditions
- Asthma, Allergic
- Keywords
- asthma, airway hyperresponsiveness, mast cell, Thymic stromal lymphopoietin, tezepelumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- University of Saskatchewan
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 23 Feb 2023 (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.
Asthma is a condition where small inhaled particles can cause inflammation in the lung leading to constriction of airways and wheeze. Mast cells are immune cells in airways that can release chemical causing constriction of the airways and wheeze. Tezepelumab is an injectable medication that improves asthma by stopping inflammation, but the effect on mast cells is not known. Tezepelumab was approved in Canada July 2022 for treatment of severe asthma. Tezepelumab is not approved for treatment of mild asthma by any health authority, except for use in research studies like this. This study will examine the effect of tezepelumab on mast cells and airway constriction to understand the mechanisms of asthma, and which patients will benefit most from drugs like tezepelumab.
Detailed description
The proposed study will address whether tezepelumab has the unique ability to improve AHR in participants with mild allergic asthma.
This is a phase 2 multi-centre randomized double-blind placebo-controlled parallel-group study to examine the effects of 24 weeks tezepelumab 210 mg sc q4wks on methacholine airway hyperresponsiveness in participants with mild allergic asthma, stratified for sex and sensitivity to seasonal allergens.
There are 9 study visits over a period of 27 weeks (Figure 1). Study procedures performed at Weeks -1, 8, 16 and 24 will be divided across 2 visits at least 48 hours apart for measurement of AHR to methacholine first, and mannitol at least 48 hours later.
The screening period at Week -1 will determine eligibility. At Week -1, eligible allergic mild asthmatic participants will be randomized 1:1 to placebo or tezepelumab 210 mg subcutaneous administered monthly for a total of 24 weeks. AHR will be measured by methacholine and mannitol challenges at baseline (Week -1) performed at least 48 hours apart. Changes in AHR response will be measured by repeat methacholine and mannitol challenges at Weeks 8, 16 and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab | Experimental | Drug: Tezepelumabtezepelumab 210 mg sc q4wks 20 weeks treatment |
| Placebo | Placebo comparator | Drug: Placeboplacebo sc q4wks 20 weeks treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent prior to any study specific procedures
- Male and female 18 through 65 years of age
- Positive skin-prick test to a common aeroallergen
- Methacholine PD20 ≤ 200mcg
- Mannitol DRR ≤ 42.3mg/FEV1 %f all (equivalent to PD15 ≤ 635mg)
Key exclusion criteria (13 listed)
- Current or former smoker with >10-pack-year history
- Current or previous history of lung disease other than mild stable allergic asthma
- Significant systemic disease, including history of current malignancy or autoimmune disease
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previous randomisation in the present study. Re-screening (Week -1) for FEV1 and AHR is permitted once for each test.
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 |
|---|---|---|
| Tezepelumabtezepelumab 210 mg sc q4wks for 20 weeks | Drug | Tezepelumab |
| Placeboplacebo sc q4wks for 20 weeks | Drug | Placebo |
Primary outcome
Methacholine PD20
Time frame: Week -1 to Week 24
The provocative dose of methacholine causing 20% fall in FEV1
2 secondary outcomes
Dose response ratio to mannitol
Time frame: Week -1 to Week 24
Mast cell tryptase levels.
Time frame: Week -1 to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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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.
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 Phase 2 study testing Tezepelumab in people with Asthma, Allergic, 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 7 inclusion and 13 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 23 Feb 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 M 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?
Methacholine PD20 (time frame: Week -1 to Week 24). 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 23 Feb 2023.