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Completed

NCT Number: NCT03371459

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

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Winter Park, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AS MDI

Drug

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

Proventil

Drug

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

Primary outcomes

  1. Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose

    Time frame: 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

    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

Secondary outcomes

  1. Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose

    Time frame: Over 6 hours post dose on Day 1

    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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 13, 2017
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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