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

NCT03371459 | Completed Phase 2 Results FDA Drug

• 1 other identifier: D6930C00002
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose

  Over 6 hours post dose on Day 1

Study Arms (2)

AS MDI

EXPERIMENTAL

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

Drug: AS MDI

Proventil

ACTIVE COMPARATOR

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

Drug: Proventil

Interventions

AS MDI DRUG

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

AS MDI

Proventil DRUG

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

Proventil

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (5)

Research Site

Winter Park, Florida, 32789, United States

Location

Research Site

North Dartmouth, Massachusetts, 02747, United States

Location

Research Site

St Louis, Missouri, 63141, United States

Location

Research Site

Raleigh, North Carolina, 27607, United States

Location

Research Site

Medford, Oregon, 97504, United States

Location

Related Publications (1)

• Cappelletti C, Maes A, Rossman K, Gillen M, LaForce C, Kerwin EM, Reisner C. Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA Trials. Clin Drug Investig. 2021 Jun;41(6):579-590. doi: 10.1007/s40261-021-01040-7. Epub 2021 Jun 4.

  PMID: 34089147 DERIVED

Related Links

• Protocol
• Statistical Analysis Plan (SAP)

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Colin Reisner, MD FCCP, FAAAAI
• Organization: Pearl Therapeutics, Inc, a Member of the AstraZeneca Group

Colin.Reisner@astrazeneca.com

9739750321

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 13, 2017
• Study Start: December 29, 2017
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: July 23, 2019
• Results First Posted: July 23, 2019

Record last verified: 2019-06

Locations

US (5)