Clinical trial NCT05505734: A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
Official title: A Multicenter, Randomized, Double-blind, Parallel-group, Event-driven, Decentralized, Phase IIIb Study Comparing PT027 With PT007 Administered as Needed in Participants 12 Years of Age and Older With Asthma (BATURA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Metered-dose inhaler (MDI)
Leukotriene receptor agonist (LTRA)
Inhaled corticosteroid (ICS)
Short -acting β2agonist (SABA)
Lead sponsor: Bond Avillion 2 Development LP
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2022-08-18
Enrollment: 2517
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a US study comparing the efficacy and safety of BDA MDI \[Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)\] with AS \[Albuterol Sulfate\] MDI, both are administered as needed for up to 12 months.

Detailed description: This is a phase IIIb, multicenter, randomized, double-blind, parallel-group, event-driven, variable-length, decentralized study.

Participants from around 40 to 50 centers located in the US will be screened and randomized 1:1 to receive one of the following two treatments to be used as needed: BDA MDI (160/180 μg) and AS MDI (180 μg). Participants 12 years of age and older with asthma will be recruited with all visits conducted virtually.

Eligible participants must be using as-needed SABA (Short -acting β2agonist) alone, or as-needed SABA on a background of either low-dose ICS (Inhaled corticosteroid) or a LTRA (Leukotriene receptor agonist), for the treatment of asthma.

Participants will be stratified by pre-study asthma medication (SABA only, low-dose ICS + SABA and LTRA + SABA) and number of prior severe exacerbations (0, ≥1) in the 12 months prior to the Screening visit.

Eligibility criteria: Inclusion Criteria:

1. Participant must be ≥12 years of age, at the time of signing the electronic informed consent form (eICF). For participants from 12 years of age to age of majority, their parents/legal guardian must provide signed consent, as appropriate, and participants will sign an assent form.
2. Diagnosis of asthma by a prescribing healthcare professional. Protocol-specified documentation of asthma diagnosis is required to confirm diagnosis of asthma.
3. Participants actively using SABA alone or SABA on a background of either low-dose ICS or LTRA.
4. Self-reported use of a SABA on ≥2 occasions, in response to symptoms (ie, not for exercise prophylaxis only), in the previous 2 weeks prior to enrollment.
5. An Asthma Impairment and Risk Questionnaire (AIRQ) score of ≥2 at Screening (Visit1/re-screen) and Randomisation (Randomization (Visit2) where applicable. Note, where screening Visit1/re-screen and randomization occur on the same day, AIRQ will only be completed once.
6. Females of child-bearing potential must have a negative pregnancy test prior to randomization and agree to use an acceptable method of contraception throughout the study.
7. Male participants who are in heterosexual relationships must be surgically sterile or agree to use an effective method of contraception (condom) if the female partner does not use contraception from the date the eICF is signed until 2 weeks after their last dose.

Exclusion Criteria:

1. Any evidence of significant lung disease other than asthma, such as chronic obstructive pulmonary disease, emphysema, idiopathic pulmonary fibrosis, sarcoidosis etc or any other significant disease (like malignancies or severe chronic diseases) that by Investigator judgment would interfere with the participant being able to comply with study procedures or complete the study.
2. Hospitalization due to asthma in the 3 months prior to enrollment or self-reported admission to the Intensive Care Unit with life-threatening asthma at any time in the past
3. Self-reported use of inhaled Long-Acting Beta-Agonists (LABA), theophylline, inhaled anticholinergic agent, cromone or medium/high dose ICS daily, as regular maintenance asthma therapy in the 3 months prior to enrollment
4. Self-reported use of systemic corticosteroids (SCS) for the treatment of asthma and any other condition in the 6 weeks prior to enrollment
5. Participants with a home supply of oral corticosteroids (OCS) to be used in the case of an asthma exacerbation or any other condition that could require a course of OCS, who are not willing to commit to the treating physician to stop using this medication for the duration of the study.
6. Receipt of any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) or investigational biologic for the treatment of asthma at any time in the past
7. Receipt of bronchothermoplasty
8. Use of a SABA prophylactically primarily to prevent exercise induced bronchospasm (EIB) and not to treat symptoms
9. Currently receiving systemic treatment with potent cytochrome P3A4 inhibitors (eg, ketoconazole, itraconazole, and ritonavir)
10. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
11. Previous screening, enrollment or randomization in the present study.
12. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
13. Participants without access to a smartphone or the internet.

Primary outcomes:
measure: Time to first severe asthma exacerbation
timeFrame: Up to Week 52
Secondary outcomes:
measure: Time to first severe asthma exacerbation (≥12 years)
timeFrame: Up to Week 52
measure: Time to first severe asthma exacerbation (≥18 years)
timeFrame: Up to Week 52
measure: Time to first severe asthma exacerbation
timeFrame: Up to Week 52
measure: Annualized rate of severe asthma exacerbations (≥12 years)
timeFrame: Up to Week 52
measure: Annualized rate of severe asthma exacerbations (≥18 years)
timeFrame: Up to Week 52
measure: Total amount (mg/year) per participant of systemic glucocorticoid exposure (≥12 years)
timeFrame: Up to Week 52
measure: Total amount (mg/year) per participant of systemic glucocorticoid exposure (≥18 years)
timeFrame: Up to Week 52
measure: Total days of systemic glucocorticoid exposure (≥12 years)
timeFrame: Up to Week 52
measure: Total days of systemic glucocorticoid exposure (≥18 years)
timeFrame: Up to Week 52
measure: Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
timeFrame: From screening (Day -28 to 0) to end of the study or early study discontinuation (Upto Week 52)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pulmonary Associates of Mobile PC
state: Alabama
city: Paradise Valley
country: United States
facility: One of a Kind Clinical Research Center
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine/CCT Research
state: Arizona
city: Bakersfield
country: United States
facility: Kern Research Inc.
state: California
city: Culver City
country: United States
facility: Science 37
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: San Diego
country: United States
facility: Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
state: California
city: Walnut Creek
country: United States
facility: Clinical Research of California
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates
state: Colorado
city: Denver
country: United States
facility: Velocity Clinical Research, Denver
state: Colorado
city: Boynton Beach
country: United States
facility: Helix Biomedics
state: Florida
city: Tallahassee
country: United States
facility: Allergy and Asthma Diagnostic Treatment Center
state: Florida
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Lilburn
country: United States
facility: Lifeline Primary Care
state: Georgia
city: Savannah
country: United States
facility: Javara Inc./Privia Medical Group Georgia, LLC
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso
state: Indiana
city: Lafayette
country: United States
facility: Velocity Clinical Research
state: Louisiana
city: Annapolis
country: United States
facility: Javara Inc.
state: Maryland
city: Baltimore
country: United States
facility: Baltimore Early Phase Clinical Unit (EPCU)
state: Maryland
city: White Marsh
country: United States
facility: Chesapeake Clinical Research
state: Maryland
city: Fall River
country: United States
facility: Genesis Clinical Research and Consulting, LLC
state: Massachusetts
city: North Dartmouth
country: United States
facility: Infinity Medical Research
state: Massachusetts
city: Mankato
country: United States
facility: Mankato Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Spectrum Clinical Research
state: Missouri
city: Lincoln
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Midwest Regional Health Services, LLC/CCT Research
state: Nebraska
city: Endwell
country: United States
facility: Meridian Clinical Research
state: New York
city: New York
country: United States
facility: Modern Migraine MD/CTNX
state: New York
city: Charlotte
country: United States
facility: Javara Inc.
state: North Carolina
city: Clemmons
country: United States
facility: Javara Inc/Wake Forest Health Network, LLC
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Health (Innovo Research)
state: North Carolina
city: Columbus
country: United States
facility: Buckeye Health and Research
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Resarch - Medford
state: Oregon
city: Portland
country: United States
facility: Northwest Research Center
state: Oregon
city: Hatboro
country: United States
facility: Hatboro Medical Associates
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research - Providence
state: Rhode Island
city: Warwick
country: United States
facility: AAPRI Clinical Research Institute
state: Rhode Island
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
city: Anderson
country: United States
facility: Velocity Clinical Research - Anderson
state: South Carolina
city: Greenville
country: United States
facility: Velocity Clinical Research, Greenville
state: South Carolina
city: Cedar Park
country: United States
facility: Velocity Clinical Research, Austin
state: Texas
city: Cypress
country: United States
facility: Privia Medical Group Gulf Coast
state: Texas
city: Denison
country: United States
facility: CardioVoyage LLC
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas
state: Texas
city: Friendswood
country: United States
facility: Allure Health at Mt Olympus Medical Research
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research
state: Texas
city: Ogden
country: United States
facility: South Ogden Family Medicine clinic
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research -Salt Lake City
state: Utah
city: Portsmouth
country: United States
facility: Meridian Clinical Research
state: Virginia
Study officials:
References: