- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02347085
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI
June 19, 2018 updated by: Pearl Therapeutics, Inc.
A Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003 and Placebo MDI
Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003 and Placebo MDI
Study Overview
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Phase 3
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:
- At least 40 years of age and no older than 80 at Screening
- Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking
- Pre- and post-bronchodilator FEV1/FVC ratio of <0.70
- Post-bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 <30% of predicted normal value
Exclusion Criteria:
- Significant diseases other than COPD, i.e., 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
- Women who are pregnant or lactating
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma
- Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period
- Subjects who have clinically significant uncontrolled hypertension.
- Subjects who have cancer that has not been in complete remission for at least five years
- Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing
- Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible
- Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study
- Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GFF MDI (PT003)
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
|
Other Names:
|
Placebo Comparator: Placebo MDI
Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FEV1 AUC0-24 on Day 29
Time Frame: Day 29
|
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29
|
Day 29
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morning Pre-Dose Trough FEV1 on Day 30
Time Frame: Day 30
|
Morning Pre-Dose Trough FEV1 on Day 30
|
Day 30
|
FEV1 AUC12-24 on Day 29
Time Frame: Day 29
|
FEV1 AUC12-24 on Day 29
|
Day 29
|
FEV1 AUC0-12 on Day 29
Time Frame: Day 29
|
FEV1 AUC0-12 on Day 29
|
Day 29
|
Peak Change From Baseline in FEV1 on Day 29
Time Frame: Day 29
|
Peak Change From Baseline in FEV1 following evening Dose on Day 29
|
Day 29
|
Peak Change From Baseline in FEV1 on Day 29
Time Frame: Day 29
|
Peak Change From Baseline in FEV1 following the morning dose on Day 29
|
Day 29
|
Morning Pre-Dose Trough FEV1 on Day 29
Time Frame: Day 29
|
Morning Pre-Dose Trough FEV on Day 29
|
Day 29
|
Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29
Time Frame: Day 29
|
Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29
|
Day 29
|
Peak Change From Baseline in IC Following the Morning Dose on Day 29
Time Frame: Day 29
|
Peak Change from Baseline in IC following the morning dose on Day 29
|
Day 29
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Colin Reisner, MD, Pearl Therapeutics
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)
February 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
January 21, 2015
First Submitted That Met QC Criteria
January 26, 2015
First Posted (Estimate)
January 27, 2015
Study Record Updates
Last Update Posted (Actual)
July 19, 2018
Last Update Submitted That Met QC Criteria
June 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Adrenergic Agonists
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Glycopyrrolate
- Formoterol Fumarate
Other Study ID Numbers
- PT003012
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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