A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
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|ClinicalTrials.gov Identifier: NCT05505734|
Recruitment Status : Recruiting
First Posted : August 18, 2022
Last Update Posted : November 24, 2023
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: BDA MDI Drug: AS MDI||Phase 3|
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 (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Actual Study Start Date :||September 2, 2022|
|Estimated Primary Completion Date :||March 27, 2025|
|Estimated Study Completion Date :||March 27, 2025|
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.
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.
- Time to first severe asthma exacerbation [ Time Frame: Up to Week 52 ]The time to first severe asthma exacerbation will be analyzed under the While on Treatment estimand 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 with asthma previously receiving SABA alone or SABA as needed on a background of low-dose ICS or a LTRA.
- Time to first severe asthma exacerbation [ Time Frame: Up to Week 52 ]The time to first severe exacerbation will analyzed under the Treatment Policy estimand 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 with asthma who are taking SABA as needed alone or with a stable low-dose ICS or LTRA.
- Annualized rate of severe asthma exacerbations [ Time Frame: Up to Week 52 ]The annualized rate of severe asthma exacerbations will be evaluated based While on the Treatment estimand, 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.
- Total amount (mg/year) per participant of systemic glucocorticoid exposure [ Time Frame: Up to Week 52 ]The total systemic corticosteroid exposure will be expressed as the annualized total dose of systemic corticosteroid (SCS) (mg/year) (While on Treatment estimand). To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure associated with asthma management.
- Total days of systemic glucocorticoid exposure [ Time Frame: Up to Week 52 ]To evaluate the effect of BDA MDI as needed compared with AS MDI as needed on systemic glucocorticoid exposure (While on Treatment estimand), associated with asthma management.
- Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs) [ Time Frame: From screening (Day -28 to 0) to end of the study or early study discontinuation (Upto Week 52) ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05505734
|Contact: Adrian Nardi, Project Director||+54 11 email@example.com|
|Contact: Ieva Imbrasaite, Project Leader||+370 5 firstname.lastname@example.org|