A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Time to first severe asthma exacerbation [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 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 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.
Secondary Outcome Measures
- Time to first severe asthma exacerbation [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 [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 [Up to Week 52]
The total systemic corticosteroid exposure will be expressed as the annualized total dose of 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 [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) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant must be ≥12 years of age, at the time of signing the electronic informed consent form (eICF). For participants from 12 to <18 years of age, their parents/legal guardian must provide signed consent, as appropriate, and participants will sign an assent form.
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Diagnosis of asthma by a prescribing healthcare professional. Documentation of asthma diagnosis should be supported by medical records or a letter from the treating physician confirming diagnosis of asthma.
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Participants actively using SABA alone or SABA on a background of either low-dose ICS or LTRA.
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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.
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An Asthma Impairment and Risk Questionnaire (AIRQ) score of ≥2 at Screening (V1) and Randomisation (V2) where applicable. Note, where screening and randomization occur on the same day, AIRQ will only be completed once.
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Females of child-bearing potential and sexually active in heterosexual relationships must have a negative pregnancy test prior to randomization and agree to use an acceptable method of contraception throughout the study.
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Male participants who are sexually active in heterosexual relationships must be surgically sterile or agree to use a double-barrier effective method of contraception from the date the eICF is signed until 2 weeks after their last dose.
Exclusion Criteria:
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Any evidence of significant lung disease other than asthma, such as chronic obstructive pulmonary disease (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), sarcoidosis etc.
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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
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Self-reported use of LABA, theophylline, anticholinergic agent, cromone or medium/high dose ICS daily, as regular maintenance asthma therapy in the 3 months prior to enrollment
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Self-reported use of systemic corticosteroids for the treatment of asthma in the prior 6 weeks to enrollment
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Participants with a home supply of oral corticosteroids (OCS) to be used in the case of an asthma exacerbation who are not willing to relinquish the medication to their treating physician for the duration of the study
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Receipt of any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic for the treatment of asthma at any time in the past
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Receipt of bronchothermoplasty
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Use a SABA prophylactically primarily to prevent exercise induced bronchospasm (EIB) and not to treat symptoms
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Currently receiving systemic treatment with potent cytochrome P3A4 inhibitors (eg, ketoconazole, itraconazole, and ritonavir)
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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.
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Previous screening, enrollment or randomization in the present study.
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For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
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Participants without access to a smartphone or the internet.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bond Avillion 2 Development LP
- Parexel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AV007