Clinical Trials/NCT01854645

NCT01854645

Completed

Phase 3

A Randomized, Double Blind, Chronic Dosing, Placebo-Controlled, Parallel Group, Multi Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control

Pearl Therapeutics, Inc.1 site in 1 country2,103 target enrollmentMay 2013

ConditionsChronic Obstructive Pulmonary Disease

InterventionsGFF MDI GP MDI FF MDI Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)Placebo MDI

DrugsGFF MDI GP MDI FF MDI Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)Placebo MDI

Overview

Phase: Phase 3
Intervention: GFF MDI
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Pearl Therapeutics, Inc.
Enrollment: 2103
Locations: 1
Primary Endpoint: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

February 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pearl Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects at least 40 years of age and no older than 80 at 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.
•Average f the -60 and the -30 min pre-dose FEV1 assessments must be \< 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
•Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Exclusion Criteria

•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) New York Heart Association (NYHA) Class III/IV)
•Clinically significant abnormal 12-lead ECG

Arms & Interventions

GFF MDI

Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)

Intervention: GFF MDI

GP MDI

Glycopyrronium (GP) MDI (PT001)

Intervention: GP MDI

FF MDI

Formoterol Fumarate (FF) MDI (PT005)

Intervention: FF MDI

Open-label tiotropium bromide inhalation powder

Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)

Intervention: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)

Placebo

Placebo MDI

Intervention: Placebo MDI

Outcomes

Primary Outcomes

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24

Time Frame: Baseline and at Week 24

Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24

Secondary Outcomes

Rescue Ventolin Hydrofluoroalkane (HFA) Use(Baseline and at Week 24)
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks(Baseline and Weeks 2 to 24)
St. George's Respiratory Questionnaire (SGRQ) Score(Baseline and at Week 24)
Onset of Action as Assessed by FEV1(Assessed for 5- and 15-minute post dose on Day 1)
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose(Baseline and at Week 24)