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

This study has been completed.
Sponsor:
Collaborators:
The VA Western New York Healthcare System
Buffalo Institute For Medical Research
Information provided by:
Pulmatrix Inc.
ClinicalTrials.gov Identifier:
NCT01096173
First received: March 25, 2010
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Official Title: Determination of the in Vitro Effects of CALM on COPD Sputum

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pulmatrix Inc.:

Biospecimen Retention:   None Retained

Sputum samples


Estimated Enrollment: 10
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient clinic setting

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096173

Locations
United States, New York
VA WNY Healthcare System
Buffalo, New York, United States, 14215
Sponsors and Collaborators
Pulmatrix Inc.
The VA Western New York Healthcare System
Buffalo Institute For Medical Research
Investigators
Principal Investigator: Sanjay Sethi, MD Va Western NY Healthcare, Buffalo Institute for Medical Research
  More Information

No publications provided

Responsible Party: Dr. Sanjay Sethi, MD, VA of Western NY Healthcare System, Buffalo Institute for Medical Research
ClinicalTrials.gov Identifier: NCT01096173     History of Changes
Other Study ID Numbers: PUL_VABUF_01
Study First Received: March 25, 2010
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Pulmatrix Inc.:
Sputum
chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013