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

NCT05505734 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: AV007
• Study Type: interventional
• Target: 2,516
• Locations: 1 country
• Sites: 61

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.

Conditions

Asthma

Keywords

Metered-dose inhaler (MDI); Leukotriene receptor agonist (LTRA); Inhaled corticosteroid (ICS); Short -acting β2agonist (SABA)

Outcome Measures

Primary Outcomes (1)

• Time to First Severe Asthma Exacerbation, While on Treatment Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years)

  The time to first severe asthma exacerbation was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of the first severe asthma exacerbation event. Participants were censored at treatment discontinuation, a step-up in maintenance therapy, or interim analysis DCO. An asthma exacerbation was considered severe if it resulted in at least one of the following: use of systemic steroids for at least 3 days, inpatient hospitalization due to asthma or emergency room visit that required systemic steroids, or death due to asthma. The primary outcome measure was analyzed at the interim analysis (22 April 2024). Since the primary objective was met at the interim analysis, it was not re-tested at final database lock. Since fewer than 50% of participants had an exacerbation event, the median survival time could not be calculated and instead the number of participants with an event is reported.

  From treatment initiation until the earliest occurrence of study completion, treatment discontinuation, step-up in maintenance therapy, or interim analysis DCO, up to one year following treatment initiation.

Secondary Outcomes (9)

• Time to First Severe Asthma Exacerbation, Treatment Policy Strategy, Interim Analysis Data Cut-off (Participants Aged >=12 Years)

  From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation, a step-up in maintenance therapy or interim analysis DCO, up to one year following treatment initiation.

• Time to First Severe Asthma Exacerbation, While on Treatment Strategy (Participants Aged >=18 Years)

  From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.

• Time to First Severe Asthma Exacerbation, Treatment Policy Strategy (Participants Aged >=18 Years)

  From treatment initiation until the earliest occurrence of study completion or withdrawal only, regardless of treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.

• Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=12 Years)

  From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.

• Annualized Severe Asthma Exacerbation Rate, While on Treatment Strategy (Participants Aged >=18 Years)

  From treatment initiation until the earliest occurrence of study completion, treatment discontinuation or a step-up in maintenance therapy, up to one year following treatment initiation.

Study Arms (2)

PT027

EXPERIMENTAL

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

PT007

EXPERIMENTAL

Participants will receive Albuterol Sulfate Pressurised Inhalation Suspension 180 μg up to a maximum of 12 inhalations to max dose.

Drug: AS MDI

Interventions

BDA MDI DRUG

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.

PT027

AS MDI DRUG

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.

PT007

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Diagnosis of asthma by a prescribing healthcare professional. Protocol-specified documentation of asthma diagnosis is required to confirm diagnosis of asthma.
• Participants actively using SABA alone or SABA on a background of either low-dose ICS or LTRA.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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
• 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
• Self-reported use of systemic corticosteroids (SCS) for the treatment of asthma and any other condition in the 6 weeks prior to enrollment
• 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.
• 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
• Receipt of bronchothermoplasty
• Use of a SABA prophylactically primarily to prevent exercise induced bronchospasm (EIB) and not to treat symptoms
• Currently receiving systemic treatment with potent cytochrome P3A4 inhibitors (eg, ketoconazole, itraconazole, and ritonavir)
• 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.
• Previous screening, enrollment or randomization in the present study.
• For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
• Participants without access to a smartphone or the internet.

Sponsors & Collaborators

• Bond Avillion 2 Development LP: lead
• Parexel: collaborator

Study Sites (61)

Pulmonary Associates of Mobile PC

Mobile, Alabama, 36608, United States

Location

One of a Kind Clinical Research Center

Paradise Valley, Arizona, 85253, United States

Location

Fiel Family and Sports Medicine/CCT Research

Tempe, Arizona, 85283, United States

Location

Kern Research Inc.

Bakersfield, California, 93301, United States

Location

Science 37

Culver City, California, 90230, United States

Location

Antelope Valley Clinical Trials

Lancaster, California, 93534, United States

Location

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

San Diego, California, 92123, United States

Location

Clinical Research of California

Walnut Creek, California, 94598, United States

Location

Asthma and Allergy Associates

Colorado Springs, Colorado, 80907, United States

Location

Velocity Clinical Research, Denver

Denver, Colorado, 80209, United States

Location

Helix Biomedics

Boynton Beach, Florida, 33435, United States

Location

Allergy and Asthma Diagnostic Treatment Center

Tallahassee, Florida, 32308, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Centricity Research

Columbus, Georgia, 31905, United States

Location

Centricity Research

Columbus, Georgia, 31906, United States

Location

Centricity Research

Columbus, Georgia, 31907, United States

Location

Lifeline Primary Care

Lilburn, Georgia, 30047, United States

Location

Javara Inc./Privia Medical Group Georgia, LLC

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

Location

Velocity Clinical Research - Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Velocity Clinical Research

Lafayette, Louisiana, 70508, United States

Location

Javara Inc.

Annapolis, Maryland, 21401, United States

Location

Baltimore Early Phase Clinical Unit (EPCU)

Baltimore, Maryland, 21225, United States

Location

Chesapeake Clinical Research

White Marsh, Maryland, 21162, United States

Location

Genesis Clinical Research and Consulting, LLC

Fall River, Massachusetts, 02723, United States

Location

Infinity Medical Research

North Dartmouth, Massachusetts, 02747, United States

Location

Mankato Clinic

Mankato, Minnesota, 56001, United States

Location

Spectrum Clinical Research

Kansas City, Missouri, 64118, United States

Location

Meridian Clinical Research, LLC

Lincoln, Nebraska, 68510, United States

Location

Midwest Regional Health Services, LLC/CCT Research

Omaha, Nebraska, 68144, United States

Location

Meridian Clinical Research

Endwell, New York, 13760, United States

Location

Modern Migraine MD/CTNX

New York, New York, 10001, United States

Location

Javara Inc.

Charlotte, North Carolina, 28277, United States

Location

Javara Inc/Wake Forest Health Network, LLC

Clemmons, North Carolina, 27012, United States

Location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Wilmington Health (Innovo Research)

Wilmington, North Carolina, 28401, United States

Location

Buckeye Health and Research

Columbus, Ohio, 43207, United States

Location

Velocity Clinical Resarch - Medford

Medford, Oregon, 97504, United States

Location

Northwest Research Center

Portland, Oregon, 97202, United States

Location

Hatboro Medical Associates

Hatboro, Pennsylvania, 19040, United States

Location

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States

Location

AAPRI Clinical Research Institute

Warwick, Rhode Island, 02886, United States

Location

CVS Health

Woonsocket, Rhode Island, 02895, United States

Location

CVS Health

Woonsocket, Rhode Island, 02896, United States

Location

CVS Health

Woonsocket, Rhode Island, 02897, United States

Location

CVS Health

Woonsocket, Rhode Island, 02898, United States

Location

CVS Health

Woonsocket, Rhode Island, 02899, United States

Location

CVS Health

Woonsocket, Rhode Island, 02900, United States

Location

Velocity Clinical Research - Anderson

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research, Greenville

Greenville, South Carolina, 29615, United States

Location

Velocity Clinical Research, Austin

Cedar Park, Texas, 78759, United States

Location

Privia Medical Group Gulf Coast

Cypress, Texas, 77433, United States

Location

CardioVoyage LLC

Denison, Texas, 75020, United States

Location

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

Fort Worth, Texas, 76133, United States

Location

Allure Health at Mt Olympus Medical Research

Friendswood, Texas, 77546, United States

Location

LinQ Research, LLC

Pearland, Texas, 77584, United States

Location

Mt. Olympus Medical Research

Sugar Land, Texas, 77479, United States

Location

South Ogden Family Medicine clinic

Ogden, Utah, 84405, United States

Location

Velocity Clinical Research -Salt Lake City

West Jordan, Utah, 84088, United States

Location

Meridian Clinical Research

Portsmouth, Virginia, 23703, United States

Location

Related Publications (1)

• LaForce C, Albers F, Danilewicz A, Jeynes-Ellis A, Kraft M, Panettieri RA Jr, Rees R, Bardsley S, Dunsire L, Harrison T, Sobande O, Surujbally R, Trudo F, Cappelletti C, Papi A, Beasley R, Chipps BE, Israel E, Pandya H, Clancy M, Bacharier LB; BATURA Investigators. As-Needed Albuterol-Budesonide in Mild Asthma. N Engl J Med. 2025 Jul 10;393(2):113-124. doi: 10.1056/NEJMoa2504544. Epub 2025 May 19.

  PMID: 40388330 DERIVED

Related Links

• Study Design Publication

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avillion Life Sciences

contact@avillionls.com

+44 (0)203 764 9530

Study Officials

• Craig LaForce, MD

  North Carolina Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 18, 2022
• Study Start: September 2, 2022
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (61)