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Completed

NCT Number: NCT05505734

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

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pulmonary Associates of Mobile PC, Mobile, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

    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.

Secondary outcomes

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

    Time frame: 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.

    The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation occurred. Participants were censored at study completion or withdrawal, or the 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 key secondary outcome measure was analyzed at the interim analysis (22 April 2024). Since the key secondary 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.

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

    Time frame: 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.

    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 first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Participants were censored at treatment discontinuation or a step-up in maintenance therapy. An asthma exacerbation was considered severe if it results 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. 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.

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

    Time frame: 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.

    The time to first severe asthma exacerbation was analyzed under the Treatment Policy strategy in the Full analysis set (FAS) and was defined as the length in days from treatment initiation until the date of first severe asthma exacerbation event, including all events that occurred up to the Final DCO (20 September 2024). Participants were censored at study completion or withdrawal. 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. 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.

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

    Time frame: 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.

    The annualized exacerbation rate 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 first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. 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.

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

    Time frame: 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.

    The annualized exacerbation rate 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 first severe asthma exacerbation event, including all events that occurred up to the final DCO (20 September 2024). Time at risk was defined as the cumulative number of days in the randomized treatment period across all participants in the treatment group, excluding the days during a severe exacerbation event and the 7 days following it resolving. 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.

  6. Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years)

    Time frame: 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.

    The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.

  7. Total Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years)

    Time frame: 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.

    The total systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative dose of SCS following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.

  8. Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=12 Years)

    Time frame: 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.

    The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.

  9. Total Duration of Systemic Glucocorticoid Exposure, While on Treatment Strategy (Participants Aged >=18 Years)

    Time frame: 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.

    The total duration of systemic glucocorticoid exposure was analyzed under the While on Treatment strategy in the Full analysis set (FAS) and was defined as the cumulative days of SCS use following a severe exacerbation from treatment initiation until study completion, treatment discontinuation or a step-up in maintenance therapy. SCS were normalized to prednisone equivalents when calculating total dose, patients whose total dose could not be normalized are excluded from analysis.

Sponsors and collaborators

Lead sponsor

Bond Avillion 2 Development LP

Industry

Collaborators

  • Parexel

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2022
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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