- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02196077
Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (PT009001)
May 23, 2018 updated by: Pearl Therapeutics, Inc.
A Randomized, Double Blind, Chronic Dosing (28 Days), Four Period, Five Treatment, Incomplete Block, Multi Center, Crossover Study to Assess the Efficacy and Safety of PT009, PT008, and PT005 in Subjects With Moderate to Severe COPD
This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD.
The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Rolling Hills Estates, California, United States
- Pearl Investigative Site
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Florida
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Clearwater, Florida, United States
- Pearl Investigative Site
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Panama City, Florida, United States
- Pearl Investigative Site
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Tampa, Florida, United States
- Pearl Investigative Site
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Winter Park, Florida, United States
- Pearl Investigative Site
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Minnesota
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Edina, Minnesota, United States
- Pearl Investigative Site
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Minneapolis, Minnesota, United States
- Pearl Investigative Site
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Woodbury, Minnesota, United States
- Pearl Investigative Site
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Missouri
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Saint Charles, Missouri, United States
- Pearl Investigative Site
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North Carolina
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Charlotte, North Carolina, United States
- Pearl Investigative Site
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Ohio
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Cincinnati, Ohio, United States
- Pearl Investigative Site
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Columbus, Ohio, United States
- Pearl Investigative Site
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Dublin, Ohio, United States
- Pearl Investigative Site
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Oregon
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Medford, Oregon, United States
- Pearl Investigative Site
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South Carolina
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Easley, South Carolina, United States
- Pearl Investigative Site
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Greenville, South Carolina, United States
- Pearl Investigative Site
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Spartanburg, South Carolina, United States
- Pearl Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed Consent Form (ICF) prior to any study related procedures
- COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- Tobacco Use: Current or former smokers with a history of at least 10 pack years of cigarette smoking
- Women of non-childbearing potential or medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
- Severity of Disease: Subjects with an established clinical history of COPD and severity defined as: FEV1/forced vital capacity (FVC) ratio of <0.70; At Screening (Visit 1a/b), post bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III (Third National Health and Nutrition Examination Survey) reference equations; the measured FEV1 must also be ≥30% of predicted normal value; at Visit 2, the average of the 60 minutes and 30 minutes pre dose FEV1 assessments must be <80% predicted normal value calculated using NHANES III reference equations
- Screening clinical laboratory tests must be acceptable to the Investigator
- Screening ECG must be acceptable to the Investigator
- Chest x ray or computerized tomography (CT) scan within 6 months prior to Visit 1a must be acceptable to the Investigator.
Exclusion Criteria:
- Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
- Pregnancy, nursing female subjects, or subjects trying to conceive, or not using medically acceptable form of contraception
- Asthma: Subjects who have a primary diagnosis of asthma (Note: Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis).
- Alpha 1 Antitrypsin Deficiency: Subjects who have alpha 1 antitrypsin deficiency as the cause of COPD -Active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea (ie., in the opinion of the Investigator severity of the disorder would impact the conduct of the study)-
- Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- Poorly Controlled COPD
- History of ECG abnormalities
- Cancer not in complete remission for at least 5 years
- Clinically significant, symptomatic prostatic hypertrophy
- Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
- Clinically significant bladder neck obstruction or urinary retention
- Inadequately treated glaucoma
- History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
|
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
|
EXPERIMENTAL: BFF MDI 160/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI)160/9.6
μg; PT009 administered as 2 inhalations, twice daily (BID)
|
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
|
EXPERIMENTAL: BFF MDI 80/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
|
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
|
EXPERIMENTAL: BD MDI 320 μg
Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
|
Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
|
EXPERIMENTAL: FF MDI 9.6 μg
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
|
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FEV1 AUC0-12 on Day 29
Time Frame: Day 29
|
Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)
|
Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days
Time Frame: Over 28 days
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Over 28 days
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Peak Change From Baseline in FEV1 (in Liters) Day 15
Time Frame: Day 15
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Day 15
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|
Peak Change From Baseline in FEV1 (in Liters) Day 29
Time Frame: Day 29
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Day 29
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Peak Change From Baseline in FEV1 on Day 1
Time Frame: Day 1
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Day 1
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Forced Vital Capacity (FVC) AUC0-12 on Day 29
Time Frame: Day 29
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Day 29
|
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Transition Dyspnea Index (TDI) Focal Score on Day 29
Time Frame: Day 29
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Min/Max Range of TDI scale -9 (major deterioration) to +9 (major improvement)
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Day 29
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Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment
Time Frame: Visit 12-13 (7 days)
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Visit 12-13 (7 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Shahid Siddiqui, MD, MHSA, Pearl Therapeutics, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2014
Primary Completion (ACTUAL)
March 1, 2015
Study Completion (ACTUAL)
March 1, 2015
Study Registration Dates
First Submitted
July 16, 2014
First Submitted That Met QC Criteria
July 17, 2014
First Posted (ESTIMATE)
July 21, 2014
Study Record Updates
Last Update Posted (ACTUAL)
June 20, 2018
Last Update Submitted That Met QC Criteria
May 23, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT009001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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