A Randomized, Double-blind, Single Dose, Placebo-controlled, 5-Period, 5-Treatment, Crossover, Multi-center, Dose-ranging Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Mild to Moderate Asthma (ANTORA)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Change From Baseline in FEV1 AUC0-6
Study Overview
Brief Summary
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
Detailed Description
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
- •Oral corticosteroid use (any dose) within 6 weeks
- •Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
- •Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
- •Historical or current evidence of a clinically significant disease
- •Cancer not in complete remission for at least 5 years
- •Hospitalized for psychiatric disorder or attempted suicide within 1 year
- •Unable to abstain from protocol-defined prohibited medications during the study
Arms & Interventions
• AS MDI 90 µg
(2 actuations of 45 µg/actuation)
Intervention: AS MDI 90 μg (Drug)
• AS MDI 180 µg
(2 actuations of 90 µg/actuation)
Intervention: AS MDI 180 µg (Drug)
• Placebo MDI
(2 actuations)
Intervention: Placebo MDI (Other)
• Proventil 90 µg
(1 actuation of 90 µg/actuation)
Intervention: Proventil 90 μg (Drug)
• Proventil 180 µg
(2 actuations of 90 µg/actuation)
Intervention: Proventil 180 μg (Drug)
Outcomes
Primary Outcomes
Change From Baseline in FEV1 AUC0-6
Time Frame: Over 6 hours post dose on Day 1
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
Secondary Outcomes
- Peak Change From Baseline in FEV1(Over 6 hours post dose on Day 1)
- Change From Baseline in FEV1 AUC0-4(Over 4 hours post dose on Day 1)