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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
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE December 1, 2017
First Posted Date  ICMJE December 6, 2017
Results First Submitted Date  ICMJE March 29, 2019
Results First Posted Date  ICMJE July 24, 2019
Last Update Posted Date July 24, 2019
Actual Study Start Date  ICMJE December 15, 2017
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
Change From Baseline in FEV1 AUC0-6 [ Time Frame: Over 6 hours post dose on Day 1 ]
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
Change From Baseline in FEV1 AUC0-6 [ Time Frame: 1 Day ]
Change History Complete list of historical versions of study NCT03364608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
  • Change From Baseline in FEV1 AUC0-4 [ Time Frame: Over 4 hours post dose on Day 1 ]
    Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.
  • Peak Change From Baseline in FEV1 [ Time Frame: Over 6 hours post dose on Day 1 ]
    Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2017)
  • Change From Baseline in FEV1 AUC0-4 [ Time Frame: 1 Day ]
  • Peak Change From Baseline in FEV1 [ Time Frame: 1 Day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: AS MDI 90 μg
    AS MDI 90 μg (2 actuations of 45 μg/actuation)
    Other Name: AS MDI
  • Drug: AS MDI 180 µg
    AS MDI 180 μg (2 actuations of 90 μg/actuation)
    Other Name: AS MDI
  • Other: Placebo MDI
    Placebo MDI (2 actuations)
  • Drug: Proventil 90 μg
    Proventil 90 μg (1 actuation of 90 μg/actuation)
    Other Name: Proventil
  • Drug: Proventil 180 μg
    Proventil 180 μg (2 actuations of 90 μg/actuation)
    Other Name: Proventil
Study Arms  ICMJE
  • Experimental: • AS MDI 90 µg
    (2 actuations of 45 µg/actuation)
    Intervention: Drug: AS MDI 90 μg
  • Experimental: • AS MDI 180 µg
    (2 actuations of 90 µg/actuation)
    Intervention: Drug: AS MDI 180 µg
  • Placebo Comparator: • Placebo MDI
    (2 actuations)
    Intervention: Other: Placebo MDI
  • Active Comparator: • Proventil 90 µg
    (1 actuation of 90 µg/actuation)
    Intervention: Drug: Proventil 90 μg
  • Active Comparator: • Proventil 180 µg
    (2 actuations of 90 µg/actuation)
    Intervention: Drug: Proventil 180 μg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2018)
86
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2017)
70
Actual Study Completion Date  ICMJE March 30, 2018
Actual Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03364608
Other Study ID Numbers  ICMJE D6930C00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP