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PT001 MDI Versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01350128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-06-20

Study results available
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Summary

The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Conditions

Interventions

DRUG

PT001 MDI

PT001 MDI administered as two puffs BID for 7 days

DRUG

Ipratropium Bromide HFA Inhalation Aerosol

Taken as 2 inhalations of the 17 µg per actuation strength MDI QID

OTHER

Placebo MDI

Matching placebo to 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
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-05-01
Primary Completion
2011-10-01
Completion
2011-10-01

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 NCT01350128 on ClinicalTrials.gov