MedTrace Logo

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01085045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2017-04-26

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Conditions

Interventions

DRUG

PT003 MDI

Inhaled PT003 MDI administered as two puffs BID for 7 days

DRUG

PT005 MDI

Inhaled PT005 MDI administered as two puffs BID for 7 days

DRUG

Placebo MDI

Inhaled placebo administered as two puffs BID for 7 days

DRUG

Tiotropium bromide 18 μg (Spiriva Handihaler®)

Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days

DRUG

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days

DRUG

PT001 MDI

Inhaled PT001 MDI administered as two puffs BID for 7 days

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Reisner, M.D. · Pearl Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-11-30
Completion
2010-11-30

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 NCT01085045 on ClinicalTrials.gov