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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: BDA MDI; Drug: AS MDI

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.

• Study Type: Interventional
• Enrollment (Actual): 2518
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Pulmonary Associates of Mobile PC
  • Arizona
    • Paradise Valley, Arizona, United States, 85253
      • One of a Kind Clinical Research Center
    • Tempe, Arizona, United States, 85283
      • Fiel Family and Sports Medicine/CCT Research
  • California
    • Bakersfield, California, United States, 93301
      • Kern Research Inc.
    • Culver City, California, United States, 90230
      • Science 37
    • Lancaster, California, United States, 93534
      • Antelope Valley Clinical Trials
    • San Diego, California, United States, 92123
      • Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology
    • Walnut Creek, California, United States, 94598
      • Clinical Research of California
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates
    • Denver, Colorado, United States, 80209
      • Velocity Clinical Research, Denver
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Helix Biomedics
    • Tallahassee, Florida, United States, 32308
      • Allergy and Asthma Diagnostic Treatment Center
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Centricity Research
    • Columbus, Georgia, United States, 31905
      • Centricity Research
    • Columbus, Georgia, United States, 31906
      • Centricity Research
    • Columbus, Georgia, United States, 31907
      • Centricity Research
    • Lilburn, Georgia, United States, 30047
      • Lifeline Primary Care
    • Savannah, Georgia, United States, 31406
      • Javara Inc./Privia Medical Group Georgia, LLC
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Velocity Clinical Research - Boise
  • Indiana
    • Valparaiso, Indiana, United States, 46383
      • Velocity Clinical Research - Valparaiso
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Velocity Clinical Research
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Javara Inc.
    • Baltimore, Maryland, United States, 21225
      • Baltimore Early Phase Clinical Unit (EPCU)
    • White Marsh, Maryland, United States, 21162
      • Chesapeake Clinical Research
  • Massachusetts
    • Fall River, Massachusetts, United States, 02723
      • Genesis Clinical Research and Consulting, LLC
    • North Dartmouth, Massachusetts, United States, 02747
      • Infinity Medical Research
  • Minnesota
    • Mankato, Minnesota, United States, 56001
      • Mankato Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64118
      • Spectrum Clinical Research
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Meridian Clinical Research, LLC
    • Omaha, Nebraska, United States, 68144
      • Midwest Regional Health Services, LLC/CCT Research
  • New York
    • Endwell, New York, United States, 13760
      • Meridian Clinical Research
    • New York, New York, United States, 10001
      • Modern Migraine MD/CTNX
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Javara Inc.
    • Clemmons, North Carolina, United States, 27012
      • Javara Inc/Wake Forest Health Network, LLC
    • Monroe, North Carolina, United States, 28112
      • Monroe Biomedical Research
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Health (Innovo Research)
  • Ohio
    • Columbus, Ohio, United States, 43207
      • Buckeye Health and Research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Resarch - Medford
    • Portland, Oregon, United States, 97202
      • Northwest Research Center
  • Pennsylvania
    • Hatboro, Pennsylvania, United States, 19040
      • Hatboro Medical Associates
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research - Providence
    • Warwick, Rhode Island, United States, 02886
      • AAPRI Clinical Research Institute
    • Woonsocket, Rhode Island, United States, 02895
      • CVS Health
    • Woonsocket, Rhode Island, United States, 02896
      • CVS Health
    • Woonsocket, Rhode Island, United States, 02897
      • CVS Health
    • Woonsocket, Rhode Island, United States, 02898
      • CVS Health
    • Woonsocket, Rhode Island, United States, 02899
      • CVS Health
    • Woonsocket, Rhode Island, United States, 02900
      • CVS Health
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Velocity Clinical Research - Anderson
    • Greenville, South Carolina, United States, 29615
      • Velocity Clinical Research, Greenville
  • Texas
    • Cedar Park, Texas, United States, 78759
      • Velocity Clinical Research, Austin
    • Cypress, Texas, United States, 77433
      • Privia Medical Group Gulf Coast
    • Denison, Texas, United States, 75020
      • CardioVoyage LLC
    • Fort Worth, Texas, United States, 76133
      • Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas
    • Friendswood, Texas, United States, 77546
      • Mt. Olympus Medical Research
    • Pearland, Texas, United States, 77584
      • LinQ Research, LLC
    • Sugar Land, Texas, United States, 77479
      • Mt. Olympus Medical Research
  • Utah
    • Ogden, Utah, United States, 84405
      • South Ogden Family Medicine clinic
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research -Salt Lake City
  • Virginia
    • Portsmouth, Virginia, United States, 23703
      • Meridian Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PT027; Participants will receive Budesonide and Albuterol Sulfate Pressurised Inhalation Suspension 160/180 μg up to a maximum of 12 inhalations to max dose.	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.
Experimental: PT007; Participants will receive Albuterol Sulfate Pressurised Inhalation Suspension 180 μg up to a maximum of 12 inhalations to max dose.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bond Avillion 2 Development LP
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2022
• Primary Completion (Estimated): March 27, 2025
• Study Completion (Estimated): March 27, 2025

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Inhaled corticosteroid (ICS); Metered-dose inhaler (MDI); Leukotriene receptor agonist (LTRA); Short -acting β2agonist (SABA)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: AV007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No