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A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients

NCT01921712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2014-03-18

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

PUR0200

Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator

DRUG

PUR0200 Placebo

Randomized, single dose of inhaled placebo matched to PUR0200

DRUG

Active comparator

Randomized single dose of inhaled active comparator product

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Pulmatrix Inc.

    lead INDUSTRY

Principal Investigators

  • David Hava, Ph.D. · Pulmatrix 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
2013-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United Kingdom

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 NCT01921712 on ClinicalTrials.gov