Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma

Asthma Clinical Trial

Official title:

A Randomized, Cumulative Dose, Open-label, 2-period Crossover, Multi-center Study to Assess the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Cumulative Doses of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Cumulative Doses of Proventil® Hydrofluoroalkane (HFA; Hereafter Referred to as Proventil) as an Active Control in Subjects With Mild to Moderate Asthma (ASPEN)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371459
• Other study ID #: D6930C00002
• Status: Completed
• Phase: Phase 2
• Start date: December 29, 2017
• Est. completion date: March 26, 2018

Study information

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

Clinical Trial Summary

This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma

Description:

This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of cumulative doses of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI) compared to cumulative doses of Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) as an active control in subjects with mild to moderate asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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 =50 to <80% predicted normal value after withholding SABA =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

• Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol

• 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
AS MDI 1+1+2+4+8 inhalations of 90 µg per inhalation
• Proventil
Proventil 1+1+2+4+8 inhalations of 90 µg per inhalation

Locations

Country	Name	City	State
United States	Research Site	Medford	Oregon
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Saint Louis	Missouri
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	Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose	Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation	At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses
Secondary	Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose	The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 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 6 hours post dose on Day 1

External Links

•   Protocol
•   Statistical Analysis Plan (SAP)