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NCT01096173 Clinical Trial

Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Determination of the in Vitro Effects of CALM on COPD Sputum

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01096173
Other study ID # PUL_VABUF_01
Secondary ID
Status Completed
Phase N/A
First received March 25, 2010
Last updated April 7, 2011
Start date April 2010
Est. completion date October 2010

Study information
Verified date April 2011
Source Pulmatrix Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is intended to be an evaluation of the properties of human sputum collected from patients with COPD. It is hypothesized that cationic airway lining modulators will have beneficial effects on the rheological properties of sputum derived from patients with COPD. Approximately 10 patients with COPD will collect sputum at home for 5 days. Samples will be collected and tested in laboratory tests.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date October 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 90 Years
Eligibility Inclusion Criteria:

1. Clinical and spirometric diagnosis of COPD

2. Smoking history of at least 10 pack yrs

3. Sputum production of greater than 2 tablespoons per day by patient report.

Exclusion Criteria:

1. a primary diagnosis of asthma or bronchiectasis

2. a COPD exacerbation within 4 weeks

3. Inability to comply with study procedures.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States VA WNY Healthcare System Buffalo New York

Sponsors (3)
Lead Sponsor Collaborator
Pulmatrix Inc. Buffalo Institute For Medical Research, The VA Western New York Healthcare System

Country where clinical trial is conducted

United States, 

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