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Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD

NCT02766608 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2389

Last updated 2019-09-24

Study results available
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Summary

This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.

Conditions

  • Chronic Obstructive Pulmonary Disorder

Interventions

DRUG

BFF MDI 320/9.6 μg

Blinded Treatment

DRUG

BFF MDI 160/9.6 μg

Blinded Treatment

DRUG

FF MDI 9.6 μg

Blinded Treatment

DRUG

BD MDI 320 μg

Blinded Treatment

DRUG

Symbicort® TBH 400/12 μg BID

Open Label

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
2016-05-31
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Russia
  • South Korea

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 NCT02766608 on ClinicalTrials.gov