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

Asthma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364608
• Other study ID #: D6930C00001
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: July 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria

• Are at least 12 years of age and no older than 65 years

• Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis

• Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy

• Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society [ATS]/European Respiratory Society [ERS] acceptability/repeatability criteria

• Pre-bronchodilator FEV1 of =40 to <90% predicted normal value after withholding SABA for =6 hours

• Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of =15%

• only 2 reversibility testing attempts are allowed

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AS MDI 90 µg
AS MDI 90 µg (2 actuations of 45 µg/actuation)
• AS MDI 180 µg
AS MDI 180 µg (2 actuations of 90 µg/actuation)

Other:
• Placebo MDI
Placebo MDI (2 actuations)

Drug:
• Proventil 90 µg
Proventil 90 µg (1 actuation of 90 µg/actuation)
• Proventil 180 µg
Proventil 180 µg (2 actuations of 90 µg/actuation)

Locations

Country	Name	City	State
United States	Research Site	Cincinnati	Ohio
United States	Research Site	El Paso	Texas
United States	Research Site	Medford	Oregon
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Rolling Hills Estates	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Stockton	California
United States	Research Site	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in FEV1 AUC0-6	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.	Over 6 hours post dose on Day 1
Secondary	Change From Baseline in FEV1 AUC0-4	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.	Over 4 hours post dose on Day 1
Secondary	Peak Change From Baseline in FEV1	Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)	Over 6 hours post dose on Day 1

External Links

•   Protocol
•   Statistical Analysis Plan (SAP)