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

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ClinicalTrials.gov Identifier: NCT03364608
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: AS MDI 90 μg Drug: AS MDI 180 µg Other: Placebo MDI Drug: Proventil 90 μg Drug: Proventil 180 μg Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 15, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: • AS MDI 90 µg
(2 actuations of 45 µg/actuation)
Drug: AS MDI 90 μg
AS MDI 90 μg (2 actuations of 45 μg/actuation)
Other Name: AS MDI

Experimental: • AS MDI 180 µg
(2 actuations of 90 µg/actuation)
Drug: AS MDI 180 µg
AS MDI 180 μg (2 actuations of 90 μg/actuation)
Other Name: AS MDI

Placebo Comparator: • Placebo MDI
(2 actuations)
Other: Placebo MDI
Placebo MDI (2 actuations)

Active Comparator: • Proventil 90 µg
(1 actuation of 90 µg/actuation)
Drug: Proventil 90 μg
Proventil 90 μg (1 actuation of 90 μg/actuation)
Other Name: Proventil

Active Comparator: • Proventil 180 µg
(2 actuations of 90 µg/actuation)
Drug: Proventil 180 μg
Proventil 180 μg (2 actuations of 90 μg/actuation)
Other Name: Proventil




Primary Outcome Measures :
  1. Change from baseline in FEV1 AUC0-6 [ Time Frame: 1 Day ]

Secondary Outcome Measures :
  1. Change from baseline in FEV1 AUC0-4 [ Time Frame: 1 Day ]
  2. Peak change from baseline in FEV1 [ Time Frame: 1 Day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03364608


Locations
United States, California
Research Site
Rolling Hills Estates, California, United States, 90274
Research Site
Stockton, California, United States, 95207
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, Ohio
Research Site
Cincinnati, Ohio, United States, 45242
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
United States, South Carolina
Research Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Research Site
El Paso, Texas, United States, 79903
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03364608     History of Changes
Other Study ID Numbers: D6930C00001
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: May 2018

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:
Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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