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

Last updated: August 28, 2024
Sponsor: Bond Avillion 2 Development LP
Overall Status: Completed

Phase

3

Condition

Asthma

Treatment

AS MDI

BDA MDI

Clinical Study ID

NCT05505734
AV007
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must be ≥12 years of age, at the time of signing the electronic informedconsent form (eICF). For participants from 12 years of age to age of majority, theirparents/legal guardian must provide signed consent, as appropriate, and participantswill sign an assent form.

  2. Diagnosis of asthma by a prescribing healthcare professional. Protocol-specifieddocumentation of asthma diagnosis is required to confirm diagnosis of asthma.

  3. Participants actively using SABA alone or SABA on a background of either low-doseICS or LTRA.

  4. Self-reported use of a SABA on ≥2 occasions, in response to symptoms (ie, not forexercise 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 willonly be completed once.

  6. Females of child-bearing potential must have a negative pregnancy test prior torandomization and agree to use an acceptable method of contraception throughout thestudy.

  7. Male participants who are in heterosexual relationships must be surgically sterileor agree to use an effective method of contraception (condom) if the female partnerdoes not use contraception from the date the eICF is signed until 2 weeks aftertheir last dose.

Exclusion

Exclusion Criteria:

  1. Any evidence of significant lung disease other than asthma, such as chronicobstructive pulmonary disease, emphysema, idiopathic pulmonary fibrosis, sarcoidosisetc or any other significant disease (like malignancies or severe chronic diseases)that by Investigator judgment would interfere with the participant being able tocomply with study procedures or complete the study.

  2. Hospitalization due to asthma in the 3 months prior to enrollment or self-reportedadmission to the Intensive Care Unit with life-threatening asthma at any time in thepast

  3. Self-reported use of inhaled Long-Acting Beta-Agonists (LABA), theophylline, inhaledanticholinergic agent, cromone or medium/high dose ICS daily, as regular maintenanceasthma therapy in the 3 months prior to enrollment

  4. Self-reported use of systemic corticosteroids (SCS) for the treatment of asthma andany other condition in the 6 weeks prior to enrollment

  5. Participants with a home supply of oral corticosteroids (OCS) to be used in the caseof 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 thismedication 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 atany 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 thestudy 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) orbreastfeeding.

  13. Participants without access to a smartphone or the internet.

Study Design

Total Participants: 2517
Treatment Group(s): 2
Primary Treatment: AS MDI
Phase: 3
Study Start date:
September 02, 2022
Estimated Completion Date:
August 22, 2024

Study 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.

Connect with a study center

  • Pulmonary Associates of Mobile PC

    Mobile, Alabama 36608
    United States

    Site Not Available

  • One of a Kind Clinical Research Center

    Paradise Valley, Arizona 85253
    United States

    Site Not Available

  • Fiel Family and Sports Medicine/CCT Research

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Kern Research Inc.

    Bakersfield, California 93301
    United States

    Site Not Available

  • Science 37

    Culver City, California 90230
    United States

    Site Not Available

  • Antelope Valley Clinical Trials

    Lancaster, California 93534
    United States

    Site Not Available

  • Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology

    San Diego, California 92123
    United States

    Site Not Available

  • Clinical Research of California

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Asthma and Allergy Associates

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Velocity Clinical Research, Denver

    Denver, Colorado 80209
    United States

    Site Not Available

  • Helix Biomedics

    Boynton Beach, Florida 33435
    United States

    Site Not Available

  • Allergy and Asthma Diagnostic Treatment Center

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Centricity Research

    Columbus, Georgia 31907
    United States

    Site Not Available

  • Lifeline Primary Care

    Lilburn, Georgia 30047
    United States

    Site Not Available

  • Javara Inc./Privia Medical Group Georgia, LLC

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Velocity Clinical Research - Boise

    Meridian, Idaho 83642
    United States

    Site Not Available

  • Velocity Clinical Research - Valparaiso

    Valparaiso, Indiana 46383
    United States

    Site Not Available

  • Velocity Clinical Research

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Javara Inc.

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Baltimore Early Phase Clinical Unit (EPCU)

    Baltimore, Maryland 21225
    United States

    Site Not Available

  • Chesapeake Clinical Research

    White Marsh, Maryland 21162
    United States

    Site Not Available

  • Genesis Clinical Research and Consulting, LLC

    Fall River, Massachusetts 02723
    United States

    Site Not Available

  • Infinity Medical Research

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Mankato Clinic

    Mankato, Minnesota 56001
    United States

    Site Not Available

  • Spectrum Clinical Research

    Kansas City, Missouri 64118
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Midwest Regional Health Services, LLC/CCT Research

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Meridian Clinical Research

    Endwell, New York 13760
    United States

    Site Not Available

  • Modern Migraine MD/CTNX

    New York, New York 10001
    United States

    Site Not Available

  • Javara Inc.

    Charlotte, North Carolina 28277
    United States

    Site Not Available

  • Javara Inc/Wake Forest Health Network, LLC

    Clemmons, North Carolina 27012
    United States

    Site Not Available

  • Monroe Biomedical Research

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • North Carolina Clinical Research

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Wilmington Health (Innovo Research)

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Buckeye Health and Research

    Columbus, Ohio 43207
    United States

    Site Not Available

  • Velocity Clinical Resarch - Medford

    Medford, Oregon 97504
    United States

    Site Not Available

  • Northwest Research Center

    Portland, Oregon 97202
    United States

    Site Not Available

  • Hatboro Medical Associates

    Hatboro, Pennsylvania 19040
    United States

    Site Not Available

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island 02818
    United States

    Site Not Available

  • AAPRI Clinical Research Institute

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • CVS Health

    Woonsocket, Rhode Island 02897
    United States

    Site Not Available

  • Velocity Clinical Research - Anderson

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • Velocity Clinical Research, Greenville

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Velocity Clinical Research, Austin

    Cedar Park, Texas 78759
    United States

    Site Not Available

  • Privia Medical Group Gulf Coast

    Cypress, Texas 77433
    United States

    Site Not Available

  • CardioVoyage LLC

    Denison, Texas 75020
    United States

    Site Not Available

  • Texas Health Care, PLLC d/b/a Privia Medical Group- North Texas

    Fort Worth, Texas 76133
    United States

    Site Not Available

  • Allure Health at Mt Olympus Medical Research

    Friendswood, Texas 77546
    United States

    Site Not Available

  • Mt. Olympus Medical Research

    Friendswood, Texas 77546
    United States

    Site Not Available

  • LinQ Research, LLC

    Pearland, Texas 77584
    United States

    Site Not Available

  • Mt. Olympus Medical Research

    Sugar Land, Texas 77479
    United States

    Site Not Available

  • South Ogden Family Medicine clinic

    Ogden, Utah 84405
    United States

    Site Not Available

  • Velocity Clinical Research -Salt Lake City

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Meridian Clinical Research

    Portsmouth, Virginia 23703
    United States

    Site Not Available

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