Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: AS MDI 90 μg; Drug: Proventil 180 μg; Other: Placebo MDI; Drug: Proventil 90 μg; Drug: AS MDI 180 µg

• Registration Number: NCT03364608
• Lead Sponsor: AstraZeneca

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 Timeline

• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-06
• Study Start: 2017-12-15
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Results First Submitted: 2019-03-29
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Results First Posted: 2019-07-24
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
• AS MDI 90 µg	AS MDI 90 μg	(2 actuations of 45 µg/actuation)
• Proventil 180 µg	Proventil 180 μg	(2 actuations of 90 µg/actuation)
• Placebo MDI	Placebo MDI	(2 actuations)
• Proventil 90 µg	Proventil 90 μg	(1 actuation of 90 µg/actuation)
• AS MDI 180 µg	AS MDI 180 µg	(2 actuations of 90 µg/actuation)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in FEV1 AUC0-6	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 Outcome Measures

Name	Time	Method
Peak Change From Baseline in FEV1	Over 6 hours post dose on Day 1	Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)
Change From Baseline in FEV1 AUC0-4	Over 4 hours post dose on Day 1	Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.

Trial Locations

Locations (1)

Research Site; 🇺🇸 El Paso, Texas, United States