Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
NCT ID: NCT03364608
Last Updated: 2019-07-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
86 participants
INTERVENTIONAL
2017-12-15
2018-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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• AS MDI 90 µg
(2 actuations of 45 µg/actuation)
AS MDI 90 μg
AS MDI 90 μg (2 actuations of 45 μg/actuation)
• AS MDI 180 µg
(2 actuations of 90 µg/actuation)
AS MDI 180 µg
AS MDI 180 μg (2 actuations of 90 μg/actuation)
• Placebo MDI
(2 actuations)
Placebo MDI
Placebo MDI (2 actuations)
• Proventil 90 µg
(1 actuation of 90 µg/actuation)
Proventil 90 μg
Proventil 90 μg (1 actuation of 90 μg/actuation)
• Proventil 180 µg
(2 actuations of 90 µg/actuation)
Proventil 180 μg
Proventil 180 μg (2 actuations of 90 μg/actuation)
Interventions
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AS MDI 90 μg
AS MDI 90 μg (2 actuations of 45 μg/actuation)
AS MDI 180 µg
AS MDI 180 μg (2 actuations of 90 μg/actuation)
Placebo MDI
Placebo MDI (2 actuations)
Proventil 90 μg
Proventil 90 μg (1 actuation of 90 μg/actuation)
Proventil 180 μg
Proventil 180 μg (2 actuations of 90 μg/actuation)
Other Intervention Names
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Eligibility Criteria
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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 ≥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
* 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
12 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Rolling Hills Estates, California, United States
Research Site
Stockton, California, United States
Research Site
Winter Park, Florida, United States
Research Site
North Dartmouth, Massachusetts, United States
Research Site
St Louis, Missouri, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Medford, Oregon, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
El Paso, Texas, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D6930C00001
Identifier Type: -
Identifier Source: org_study_id
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