Exercise Induced BronchospasmPhase 3TYREENCT04234464
A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma
A Phase 3 study testing Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg in people with Exercise Induced Bronchospasm, run by Bond Avillion 2 Development LP at 6 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Exercise Induced Bronchospasm
- What is being tested?
- Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Jan 2020to 28 Aug 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female or male aged 12 to 70 years at the time of informed consent
- Documented history of asthma for at least 6 months prior to Visit 1
- Receiving 1 of the following asthma therapies with stable dosing for at least the 4 weeks before Visit 1; no other asthma therapies are permitted during the study:
- Short/rapid-acting β 2-adrenoreceptor agonist (SABA) used as needed
- Low- to medium-dose maintenance therapy with inhaled corticosteroid (ICS) and SABA used as needed
- Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)
Who cannot join
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia), including regular or occasional use of oxygen
- Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
- History of life-threatening asthma, defined by past intubations for asthma, or intensive care unit admission for asthma within the prior 24 months
- Receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to Visit 1
- Unable to tolerate the lung function testing performed after exercise challenge test without use of rescue medication
- Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
Show all 18Show fewer
- Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1, regardless if resulting in accompanying asthma symptoms aggravation or not
- Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
- Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months before Visit 1, or any other prohibited medication
- Current treatment with any investigational product or within the last 30 days of Visit 1.
- Historical or current evidence of a clinically significant disease
- Cancer not in complete remission for at least 5 years before Visit 1
- Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
- History of psychiatric disease or intellectual deficiency
- Having a scheduled or planned hospitalization during the study
- Inability (and/or unwillingness) to abstain from protocol-defined prohibited medications during the study.
- Use of any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and/or the unwillingness to stop during the study duration.
- Significant abuse of alcohol or drugs
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Burke, Virginia, 22015
Research Site
Denver, Colorado, 80230
Research Site
North Dartmouth, Massachusetts, 02747
Research Site
Raleigh, North Carolina, 27607
Research Site
Skillman, New Jersey, 08558
Research Site
St Louis, Missouri, 63109
About this study
Official title: A Randomized, Double-blind, Single-dose, 2-Period, Crossover Study to Assess the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects With Asthma
This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.
- Conditions
- Exercise Induced Bronchospasm
- Being tested
- Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg, Placebo metered-dose inhaler
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/albuterol sulfate metered-dose inhaler 160/180 μgCombination product
Also called BDA MDI 160/180 μg (PT027)
Budesonide/albuterol sulfate combination inhalation aerosol single dose
Placebo metered-dose inhalerCombination product
Also called Placebo MDI
Placebo inhalation aerosol single dose
| Study group | Role | What they receive |
|---|---|---|
| A/B - Treatment with BDA MDI 160/180 followed by treatment with Placebo MDI | Experimental | Subjects randomized to receive a single dose of BDA MDI 160/180 in treatment period 1, and a single dose of Placebo MDI in treatment period 2. Receives: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg; Combination Product: Placebo metered-dose inhaler |
| B/A - Treatment with Placebo MDI followed by treatment with BDA MDI 160/180 | Experimental | Subjects randomized to receive a single dose of Placebo MDI in treatment period 1, and a single dose of BDA MDI 160/180 in treatment period 2. Receives: Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg; Combination Product: Placebo metered-dose inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
Measured: Up to 60 minutes post exercise challenge
Secondary outcomes (1)
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10%
The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall <10% was determined.
Measured: Up to 60 minutes post exercise challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start15 Jan 2020
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced BronchospasmStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bond Avillion 2 Development LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Albers, MD, PhD, Study director, Avillion LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234464
- Sponsor's protocol ID
- AV005
- Acronym
- TYREE
- Status last verified
- Jan 2022
- First submitted
- 16 Jan 2020
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
LaForce C, Chipps BE, Albers FC, Reilly L, Johnsson E, Andrews H, Cappelletti C, Maes A, Papi A. Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. Ann Allergy Asthma Immunol. 2022 Feb;128(2):169-177. doi: 10.1016/j.anai.2021.10.020. Epub 2021 Oct 24.
PubMed 34699967
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, 2-Period, Crossover Study to Assess the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects With Asthma
- ClinicalTrials.gov ID
- NCT04234464
- Acronym / sponsor ID
- TYREE / AV005
- Conditions
- Exercise Induced Bronchospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bond Avillion 2 Development LPIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Posted 30 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A/B - Treatment with BDA MDI 160/180 followed by treatment with Placebo MDI | Experimental | Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg, Combination Product: Placebo metered-dose inhalerSubjects randomized to receive a single dose of BDA MDI 160/180 in treatment period 1, and a single dose of Placebo MDI in treatment period 2. |
| B/A - Treatment with Placebo MDI followed by treatment with BDA MDI 160/180 | Experimental | Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg, Combination Product: Placebo metered-dose inhalerSubjects randomized to receive a single dose of Placebo MDI in treatment period 1, and a single dose of BDA MDI 160/180 in treatment period 2. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male aged 12 to 70 years at the time of informed consent
- Documented history of asthma for at least 6 months prior to Visit 1
- Receiving 1 of the following asthma therapies with stable dosing for at least the 4 weeks before Visit 1; no other asthma therapies are permitted during the study:
- Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)
Key exclusion criteria (18 listed)
- Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia), including regular or occasional use of oxygen
- Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
- History of life-threatening asthma, defined by past intubations for asthma, or intensive care unit admission for asthma within the prior 24 months
- Receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to Visit 1
- Unable to tolerate the lung function testing performed after exercise challenge test without use of rescue medication
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 |
|---|---|---|
| Budesonide/albuterol sulfate metered-dose inhaler 160/180 μgAlso: BDA MDI 160/180 μg (PT027)Budesonide/albuterol sulfate combination inhalation aerosol single dose | Combination product | A/B - Treatment with BDA MDI 160/180 followed by treatment with Placebo MDI, B/A - Treatment with Placebo MDI followed by treatment with BDA MDI 160/180 |
| Placebo metered-dose inhalerAlso: Placebo MDIPlacebo inhalation aerosol single dose | Combination product | A/B - Treatment with BDA MDI 160/180 followed by treatment with Placebo MDI, B/A - Treatment with Placebo MDI followed by treatment with BDA MDI 160/180 |
Primary outcome
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge
Time frame: Up to 60 minutes post exercise challenge
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
1 secondary outcome
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10%
Time frame: Up to 60 minutes post exercise challenge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34699967LaForce C, Chipps BE, Albers FC, Reilly L, Johnsson E, Andrews H, Cappelletti C, Maes A, Papi A. Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. Ann Allergy Asthma Immunol. 2022 Feb;128(2):169-177. doi: 10.1016/j.anai.2021.10.020. Epub 2021 Oct 24.
- 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.
Frank Albers, MD, PhD study director
Avillion LLP
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg in people with Exercise Induced Bronchospasm, run by Bond Avillion 2 Development LP at 6 sites in United States.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge (time frame: Up to 60 minutes post exercise challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234464, which also lists 1 linked publication.
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 Jan 2022.