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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

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ClinicalTrials.gov Identifier: NCT03371459
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Asthma Drug: AS MDI Drug: Proventil Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 29, 2017
Actual Primary Completion Date : March 26, 2018
Actual Study Completion Date : March 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: AS MDI
AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
Drug: AS MDI
AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation

Active Comparator: Proventil
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Drug: Proventil
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation




Primary Outcome Measures :
  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 ]

Secondary Outcome Measures :
  1. Baseline-adjusted FEV1 AUC0-6 after the last cumulative dose [ Time Frame: 15, 30, 60, 120, 180, 240, 300, and 360 minutes after the last cumulative dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371459


Locations
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United States, Florida
Research Site
Winter Park, Florida, United States, 32789
United States, Massachusetts
Research Site
North Dartmouth, Massachusetts, United States, 02747
United States, Missouri
Research Site
Saint Louis, Missouri, United States, 63141
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03371459     History of Changes
Other Study ID Numbers: D6930C00002
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Albuterol
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action