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A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

NCT02727660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1876

Last updated 2019-09-26

Study results available
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Summary

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Conditions

  • Chronic Obstructive Pulmonary Disorder

Interventions

DRUG

BFF MDI (PT009) 320/9.6 μg

Blinded Treatment

DRUG

BFF MDI (PT009) 160/9.6 μg

Blinded Treatment

DRUG

FF MDI (PT005) 9.6 μg

Blinded Treatment

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-29
Primary Completion
2018-04-04
Completion
2018-04-04

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Denmark
  • Germany
  • Italy
  • Mexico
  • Norway
  • Peru
  • Puerto Rico
  • Russia
  • South Africa
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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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 NCT02727660 on ClinicalTrials.gov