Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatments gff mdi (pt 003), gp mdi (pt001), ff mdi (pt005), open-label tiotropium bromide inhalation (spiriva® handihaler®)
Phase phase 3
Sponsor Pearl Therapeutics, Inc.
Start date November 2013
End date January 2015
Trial size 850 participants
Trial identifier NCT01970878, PT003008-00

Summary

This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
gff mdi (pt 003)
GFF MDI administered as two puffs BID
(Experimental)
gp mdi (pt001)
GP MDI administered as two puffs BID
(Experimental)
ff mdi (pt005)
FF MDI administered as two puffs BID
(Active Comparator)
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
open-label tiotropium bromide inhalation (spiriva® handihaler®)
Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

Primary Outcomes

Measure
Overall safety and tolerability will be evaluated using adverse events, vital sign measurements, 12-lead ECG parameters, and clinical laboratory parameters.
time frame: 52 weeks
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1)
time frame: 52 weeks

Secondary Outcomes

Measure
Transition Dyspnea Index (TDI) score
time frame: 52 Weeks
Peak change from baseline in FEV1
time frame: 52 Weeks
Change from baseline in St. George Respiratory Questionnaire (SGRQ) total score
time frame: 52 Weeks
Change from baseline in Daily rescue Ventolin hydrofluoroalkane (HFA) use
time frame: 52 Weeks

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Key Inclusion Criteria: - Participant in/completion of previous 24-week PINNACLE Phase III Trial. - 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/forced vital capacity (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 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 electrocardiogram (ECG) - Abnormal liver function tests defined as alanine transaminase (ALT), aspartate transaminanse (AST), 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

Additional Information

Official title A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Pearl Therapeutics, Inc..