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PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

NCT01566773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2017-10-12

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

Administered as two puffs BID for 14 days

DRUG

Tiotropium Bromide

Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI

DRUG

PT001 Placebo MDI

Sponsors & Collaborators

  • Pearl Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Reisner, MD · 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
2012-03-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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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 NCT01566773 on ClinicalTrials.gov