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Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

NCT01854645 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2103

Last updated 2017-03-28

Study results available
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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.

Conditions

Interventions

DRUG

GFF MDI

GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)

DRUG

GP MDI

GP MDI administered as two puffs BID

DRUG

FF MDI

FF MDI administered as two puffs BID

DRUG

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

Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

DRUG

Placebo MDI

Inhaled placebo administered as two puffs BID

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Reisner, MD · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01854645 on ClinicalTrials.gov