A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05505734
• Other study ID #: AV007
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2, 2022
• Est. completion date: March 27, 2025

Study information

• Verified date: March 2024
• Source: Bond Avillion 2 Development LP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2518
• Est. completion date: March 27, 2025
• Est. primary completion date: March 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• BDA MDI
Participants will receive Budesonide and Albuterol Sulfate MDI 80/90 µg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route.
• AS MDI
Participants will receive Albuterol Sulfate MDI 90 µg per Actuation 1 to 6 doses (2 inhalations/dose) per day as needed via Oral inhalation route.

Locations

Country	Name	City	State
United States	Velocity Clinical Research - Anderson	Anderson	South Carolina
United States	Javara Inc.	Annapolis	Maryland
United States	Kern Research Inc.	Bakersfield	California
United States	Baltimore Early Phase Clinical Unit (EPCU)	Baltimore	Maryland
United States	Helix Biomedics	Boynton Beach	Florida
United States	Velocity Clinical Research, Austin	Cedar Park	Texas
United States	Javara Inc.	Charlotte	North Carolina
United States	Javara Inc/Wake Forest Health Network, LLC	Clemmons	North Carolina
United States	Asthma and Allergy Associates	Colorado Springs	Colorado
United States	Buckeye Health and Research	Columbus	Ohio
United States	Centricity Research	Columbus	Georgia
United States	Centricity Research	Columbus	Georgia
United States	Centricity Research	Columbus	Georgia
United States	Centricity Research	Columbus	Georgia
United States	Science 37	Culver City	California
United States	Privia Medical Group Gulf Coast	Cypress	Texas
United States	CardioVoyage LLC	Denison	Texas
United States	Velocity Clinical Research, Denver	Denver	Colorado
United States	Velocity Clinical Research - Providence	East Greenwich	Rhode Island
United States	Meridian Clinical Research	Endwell	New York
United States	Genesis Clinical Research and Consulting, LLC	Fall River	Massachusetts
United States	Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas	Fort Worth	Texas
United States	Mt. Olympus Medical Research	Friendswood	Texas
United States	Velocity Clinical Research, Greenville	Greenville	South Carolina
United States	Hatboro Medical Associates	Hatboro	Pennsylvania
United States	Spectrum Clinical Research	Kansas City	Missouri
United States	Velocity Clinical Research	Lafayette	Louisiana
United States	Antelope Valley Clinical Trials	Lancaster	California
United States	Lifeline Primary Care	Lilburn	Georgia
United States	Meridian Clinical Research, LLC	Lincoln	Nebraska
United States	Mankato Clinic	Mankato	Minnesota
United States	Velocity Clinical Resarch - Medford	Medford	Oregon
United States	Velocity Clinical Research - Boise	Meridian	Idaho
United States	Pulmonary Associates of Mobile PC	Mobile	Alabama
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Modern Migraine MD/CTNX	New York	New York
United States	Infinity Medical Research	North Dartmouth	Massachusetts
United States	South Ogden Family Medicine clinic	Ogden	Utah
United States	Midwest Regional Health Services, LLC/CCT Research	Omaha	Nebraska
United States	One of a Kind Clinical Research Center	Paradise Valley	Arizona
United States	LinQ Research, LLC	Pearland	Texas
United States	Northwest Research Center	Portland	Oregon
United States	Meridian Clinical Research	Portsmouth	Virginia
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology	San Diego	California
United States	Javara Inc./Privia Medical Group Georgia, LLC	Savannah	Georgia
United States	Mt. Olympus Medical Research	Sugar Land	Texas
United States	Allergy and Asthma Diagnostic Treatment Center	Tallahassee	Florida
United States	Fiel Family and Sports Medicine/CCT Research	Tempe	Arizona
United States	Velocity Clinical Research - Valparaiso	Valparaiso	Indiana
United States	Clinical Research of California	Walnut Creek	California
United States	AAPRI Clinical Research Institute	Warwick	Rhode Island
United States	Velocity Clinical Research -Salt Lake City	West Jordan	Utah
United States	Chesapeake Clinical Research	White Marsh	Maryland
United States	Wilmington Health (Innovo Research)	Wilmington	North Carolina
United States	CVS Health	Woonsocket	Rhode Island
United States	CVS Health	Woonsocket	Rhode Island
United States	CVS Health	Woonsocket	Rhode Island
United States	CVS Health	Woonsocket	Rhode Island
United States	CVS Health	Woonsocket	Rhode Island
United States	CVS Health	Woonsocket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Bond Avillion 2 Development LP	Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first severe asthma exacerbation	The time to first severe asthma exacerbation will be analyzed under the While on Treatment strategy in the Full analysis set (FAS) and is defined as the length in days from start of the Investigational Medicinal Products (IMP) period until the first date when the event occurs, up to the end of the study. Patients will be censored at treatment discontinuation or a step-up in maintenance therapy. To evaluate the efficacy of as needed BDA MDI compared with as needed AS MDI on the risk of severe asthma exacerbations in adult and adolescent participants (greater than or equal =12 years) with asthma previously receiving SABA alone or SABA as needed on a background of low-dose ICS or a LTRA.	Up to Week 52
Secondary	Time to first severe asthma exacerbation (=12 years)	The time to first severe exacerbation will analyzed under the Treatment Policy strategy in which all observed data while participants are in the study, regardless of whether they remain on randomized study treatment or experience a step-up in maintenance therapy, will be included in the analyses. To evaluate the efficacy of BDA MDI as needed compared with AS MDI as needed on the risk of severe asthma exacerbations in adults and adolescents (participants =12 years) with asthma who are taking SABA as needed alone or with a stable low-dose ICS or LTRA.	Up to Week 52
Secondary	Time to first severe asthma exacerbation (=18 years)	The time to first severe exacerbation will analyzed under the While on Treatment strategy in the FAS =18 years and is defined as the length in days from start of the IMP period until the first date when the event occurs, up to the end of the study. Patients will be censored at treatment discontinuation or a step-up in maintenance therapy. To evaluate the efficacy of as needed BDA MDI compared with as needed AS MDI on the risk of severe asthma exacerbations in adult participants =18 years with asthma previously receiving SABA alone or SABA as needed on a background of low-dose ICS or a LTRA.	Up to Week 52
Secondary	Time to first severe asthma exacerbation	The time to first severe exacerbation will analyzed under the Treatment Policy strategy in which all observed data while participants are in the study, regardless of whether they remain on randomized study treatment or experience a step-up in maintenance therapy, will be included in the analyses. To evaluate the efficacy of BDA MDI as needed compared with AS MDI as needed on the risk of severe asthma exacerbations in adult participants =18 years with asthma who are taking SABA as needed alone or with a stable low-dose ICS or LTRA.	Up to Week 52
Secondary	Annualized rate of severe asthma exacerbations (=12 years)	The annualized rate of severe asthma exacerbations will be evaluated based While on the Treatment strategy, where all data collected from the start of the IMP period up to the end of study participation, regardless of the occurrence of intercurrent events, will be used. To evaluate the efficacy of BDA MDI as needed compared with AS MDI as needed on the rate of severe asthma exacerbations, in adults and adolescents (participants =12 years).	Up to Week 52
Secondary	Annualized rate of severe asthma exacerbations (=18 years)	The annualized rate of severe asthma exacerbations will be evaluated based While on the Treatment strategy, where all data collected from the start of the IMP period up to the end of study participation, regardless of the occurrence of intercurrent events, will be used. To evaluate the efficacy of BDA MDI as needed compared with AS MDI as needed on the rate of severe asthma exacerbations, in adult participants =18 years.	Up to Week 52
Secondary	Total amount (mg/year) per participant of systemic glucocorticoid exposure (=12 years)	The total systemic corticosteroid exposure will be expressed as the annualized total dose of systemic corticosteroid (SCS) (mg/year) (While on Treatment strategy). To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure associated with asthma management in adults and adolescents (participants =12 years).	Up to Week 52
Secondary	Total amount (mg/year) per participant of systemic glucocorticoid exposure (=18 years)	The total systemic corticosteroid exposure will be expressed as the annualized total dose of systemic corticosteroid (SCS) (mg/year) (While on Treatment strategy). To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure associated with asthma management in adult participants =18 years.	Up to Week 52
Secondary	Total days of systemic glucocorticoid exposure (=12 years)	To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure (While on Treatment strategy), associated with asthma management. To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure associated with asthma management in adults and adolescents (participants =12 years).	Up to Week 52
Secondary	Total days of systemic glucocorticoid exposure (=18 years)	To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure (While on Treatment strategy), associated with asthma management. To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure associated with asthma management in adult participants =18 years.	Up to Week 52
Secondary	Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)	To evaluate the safety of BDA MDI as needed compared to AS MDI as needed in participants 12 years of age and older with asthma	From screening (Day -28 to 0) to end of the study or early study discontinuation (Upto Week 52)