Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
NCT ID: NCT02105012
Last Updated: 2017-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2014-04-01
2015-09-04
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
DOUBLE
Study Groups
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BD MDI 320 µg
Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID
BD MDI 320 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 160 µg
BD MDI 160 µg (PT008) administered as 2 inhalations BID
BD MDI 160 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 80 µg
BD MDI 80 µg (PT008) administered as 2 inhalations BID
BD MDI 80 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 40 µg
BD MDI 40 µg (PT008) administered as 2 inhalations BID
BD MDI 40 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Placebo MDI
Placebo MDI administered as 2 inhalations BID
Placebo MDI
Placebo MDI administered as 2 inhalations BID
Interventions
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BD MDI 320 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 160 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 80 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
BD MDI 40 µg
Budesonide Inhalation Aerosol administered as 2 inhalations BID
Placebo MDI
Placebo MDI administered as 2 inhalations BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to screening
* Currently receiving treatment with a low to medium dose of an inhaled corticosteroid (ICS) OR a combination of controller medications for at least 4 weeks preceding screening
* Pre-albuterol FEV1 of \> 60% and \< 85% of predicted normal value
* Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1 within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane (HFA)
* Asthma Symptom Criteria: Have required albuterol use on at least two of the last seven days and have an Asthma Control Questionnaire (ACQ) total score ≥ 1.5 prior to Randomization
Exclusion Criteria
* Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an emergency department visit, hospitalization or use of oral/parenteral corticosteroids within 6 weeks of screening
* Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent, seasonal or exercise-induced asthma are excluded from participation in this study
* Concurrent Respiratory Disease
* Pregnant women or nursing mothers
* A current diagnosis of Chronic Obstructive Pulmonary Disease (COPD
* Current smokers or subjects with a \> 10 pack year history of cigarettes, cigars, or pipe smoking
* Respiratory tract infection within 6 weeks prior to Visit 1
* Subjects with documented myocardial infarction within a year from screening visit
* Clinically significant abnormal ECG
* Abnormal liver function tests defined as aspartate aminotransferase (AST), alanine aminotransferace (ALT), alkaline phosphatase or total bilirubin ≥ 1.5 times upper limit of normal on repeat testing
* Subjects who have cancer that has not been in complete remission for at least 5 years
* Drug Allergy: Subjects who have a history of hypersensitivity to any component of the metered-dose inhaler (MDI)
18 Years
65 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Dorinsky, MD, FCCP
Role: STUDY_DIRECTOR
Pearl Therapeutics, Inc.
Locations
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Pearl Therapeutics Study Site
Athens, Alabama, United States
Pearl Therapeutics Study Site
Birmingham, Alabama, United States
Pearl Therapeutics Study Site
Foley, Alabama, United States
Pearl Therapeutics Study Site
Los Angeles, California, United States
Pearl Therapeutics
Los Angeles, California, United States
Pearl Therapeutics Study Site
Rolling Hills Estates, California, United States
Pearl Therapeutics Study Site
San Diego, California, United States
Pearl Therapeutics Study Site
Stockton, California, United States
Pearl Therapeutics Study Site
Clearwater, Florida, United States
Pearl Therapeutics Study Site
Clermont, Florida, United States
Pearl Therapeutics Study Site
Miami, Florida, United States
Pearl Therapeutics Study Site
Orlando, Florida, United States
Pearl Therapeutics Study Site
Ormond Beach, Florida, United States
Pearl Therapeutics Study Site
Saint Cloud, Florida, United States
Pearl Therapeutics Study Site
Sebring, Florida, United States
Pearl Therapeutics Study Site
Tampa, Florida, United States
Pearl Therapeutics Study Site
Blue Island, Illinois, United States
Pearl Therapeutics Study Site
North Dartmouth, Massachusetts, United States
Pearl Therapeutics Study Site
Hazelwood, Missouri, United States
Pearl Therapeutics Study Site
Skillman, New Jersey, United States
Pearl Therapeutics Study Site
Charlotte, North Carolina, United States
Pearl Therapeutics Study Site
Winston-Salem, North Carolina, United States
Pearl Therapeutics Study Site
Cincinnati, Ohio, United States
Pearl Therapeutics Study Site
Columbus, Ohio, United States
Pearl Therapeutics Study Site
Dayton, Ohio, United States
Pearl Therapeutics Study Site
Middleburg Heights, Ohio, United States
Pearl Therapeutics Study Site
Oregon, Ohio, United States
Pearl Therapeutics Study Site
Sylvania, Ohio, United States
Pearl Therapeutics Study Site
Toledo, Ohio, United States
Pearl Therapeutics Study Site
Oklahoma City, Oklahoma, United States
Pearl Therapeutics Study Site
Lake Oswego, Oregon, United States
Pearl Therapeutics Study Site
Medford, Oregon, United States
Pearl Therapeutics Study Site
Greenville, South Carolina, United States
Pearl Therapeutics Study Site
Spartanburg, South Carolina, United States
Pearl Therapeutics Study Site
Rapid City, South Dakota, United States
Pearl Therapeutics Study Site
Tullahoma, Tennessee, United States
Pearl Therapeutics Study Site
El Paso, Texas, United States
Pearl Therapeutics Study Site
Houston, Texas, United States
Pearl Therapeutics Study Site
Plano, Texas, United States
Pearl Therapeutics Study Site
San Antonio, Texas, United States
Pearl Therapeutics Study Site
Everett, Washington, United States
Countries
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Other Identifiers
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PT008001
Identifier Type: -
Identifier Source: org_study_id
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