PT003 MDI Dose Confirmation Study
This study has been completed.
Sponsor:
Pearl Therapeutics, Inc.
Information provided by:
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01349816
First received: May 5, 2011
Last updated: December 6, 2011
Last verified: December 2011
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Purpose
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease |
Drug: PT003 Drug: PT001 Drug: PT005 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls |
Resource links provided by NLM:
Further study details as provided by Pearl Therapeutics, Inc.:
Primary Outcome Measures:
- FEV1 AUC0-12 [ Time Frame: 7 days ] [ Designated as safety issue: No ]FEV1 AUC0-12 relative to baseline following chronic dosing (1 week).
| Estimated Enrollment: | 175 |
| Study Start Date: | June 2011 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PT003 (Dose 1)
PT003 MDI Dose 1
|
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
|
|
Experimental: PT003 (Dose 2)
PT003 MDI Dose 2
|
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
|
|
Experimental: PT003 (Dose 3)
PT003 MDI Dose 3
|
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
|
|
Experimental: PT003 (Dose 4)
PT003 MDI Dose 4
|
Drug: PT003
PT003 MDI administered as two puffs BID for 7 days
|
|
Experimental: PT001
PT001 MDI
|
Drug: PT001
PT001 MDI administered as two puffs BID for 7 days
|
|
Experimental: PT005
PT005 MDI
|
Drug: PT005
PT005 MDI administered as two puffs BID for 7 days
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
- A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
- Able to change COPD treatment as required by protocol
Key Exclusion Criteria:
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
- Abnormal chest X-ray (or CT scan) not due to the presence of COPD
- Hospitalized due to poorly controlled COPD within 3 months of Screening
- Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
- Cancer that has not been in complete remission for at least 5 years
- Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
Other inclusion/exclusion criteria as defined in the protocol
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349816
Locations
| United States, California | |
| Pearl Investigative Site | |
| Rancho Mirage, California, United States | |
| United States, Colorado | |
| Pearl Investigative Site | |
| Colorado Springs, Colorado, United States | |
| United States, Connecticut | |
| Pearl Investigative Site | |
| Waterbury, Connecticut, United States | |
| United States, Florida | |
| Pearl Investigative Site | |
| Clearwater, Florida, United States | |
| Pearl Investigative Site | |
| Pensacola, Florida, United States | |
| United States, Georgia | |
| Pearl Investigative Site | |
| Stockbridge, Georgia, United States | |
| United States, Minnesota | |
| Pearl Investigative Site | |
| Minneapolis, Minnesota, United States | |
| United States, New York | |
| Pearl Investigative Site | |
| Brooklyn, New York, United States | |
| United States, North Carolina | |
| Pearl Investigative Site | |
| Charlotte, North Carolina, United States | |
| Pearl Investigative Site | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Pearl Investigative Site | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Pearl Investigative Site | |
| Medford, Oregon, United States | |
| United States, South Carolina | |
| Pearl Investigative Site | |
| Spartanburg, South Carolina, United States | |
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
| Study Director: | Colin Reisner, M.D. | Pearl Therapeutics, Inc. |
More Information
No publications provided
| Responsible Party: | Colin Reisner, M.D./Chief Medical Officer, Pearl Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT01349816 History of Changes |
| Other Study ID Numbers: | PT003004 |
| Study First Received: | May 5, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pearl Therapeutics, Inc.:
|
COPD |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013