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Effectiveness and Safety of BIO-11006 Inhalation Solution to Treat the Overproduction of Mucus and Inflammation in COPD

NCT00648245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2011-02-10

No results posted yet for this study

Summary

The symptoms associated with COPD include overproduction of mucus and inflammation in the lungs. Overproduction of mucus results in impaired lung function and it encourages bacterial growth and associated COPD exacerbations. Therefore, a treatment that inhibits mucus overproduction or blocks inflammation could benefit COPD patients. The drug under evaluation in this study, BIO-11006 Inhalation Solution, is a new drug that may inhibit overproduction of mucus and may have important anti-inflammatory properties.

Conditions

Interventions

DRUG

BIO-11006 Inhalation Solution

75 mg of BIO-11006 administered once per day for 21 days by nebulizer

DRUG

BIO-11006 Inhalation Solution

150 mg of BIO-11006 administered once per day for 21 days by nebulizer

DRUG

BIO-11006 Inhalation Solution

75 mg of BIO-11006 administered twice per day for 21 days by nebulizer

DRUG

Placebo

Placebo given once daily for 21 days by nebulizer

DRUG

BIO-11006

125 mg BIO-11006 given twice per day for 21 days by nebulizer

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • BioMarck Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Ted C Murphy, Ph.D · BioMarck Pharmaceuticals, Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00648245 on ClinicalTrials.gov