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PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

NCT01349868 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-09-12

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

Interventions

DRUG

PT005 MDI

PT005 MDI taken as two inhalations

DRUG

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece

DRUG

Formoterol Fumarate 24 μg (Foradil® Aerolizer®)

Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece

OTHER

Placebo MDI

Matching placebo to PT005 MDI taken as two inhalations

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

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 NCT01349868 on ClinicalTrials.gov