Status:
COMPLETED
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF...
Eligibility Criteria
Inclusion
- Key
- Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
- 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.
- Subjects with FEV1/FVC ratio of \<0.70 and FEV1 \<80% predicted normal and ≥750 mL if FEV1 \<30% of predicted normal value.
- Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol
- Key
Exclusion
- Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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
- Current diagnosis of asthma or alpha-1 antitrypsin deficiency
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
- Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
- 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
- Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
- Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
- Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
- Congestive heart failure (CHF NYHA Class III/IV)
- Clinically significant abnormal 12-lead ECG
- Abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
- Cancer not in complete remission for at least five years
- History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
1615 Patients enrolled
Trial Details
Trial ID
NCT01854658
Start Date
July 1 2013
End Date
March 1 2015
Last Update
March 28 2017
Active Locations (113)
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1
Pearl Investigative Site
Birmingham, Alabama, United States
2
Pearl Investigative Site
Florence, Alabama, United States
3
Pearl Investigative Site
Jasper, Alabama, United States
4
Pearl Investigative Site
Mobile, Alabama, United States