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

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ClinicalTrials.gov Identifier: NCT01096173
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : April 11, 2011
Sponsor:
Collaborators:
The VA Western New York Healthcare System
Buffalo Institute For Medical Research
Information provided by:
Pulmatrix Inc.

Brief 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.

Condition or disease
Chronic Obstructive Pulmonary Disease

Study Type : Observational
Estimated Enrollment : 10 participants
Official Title: Determination of the in Vitro Effects of CALM on COPD Sputum
Study Start Date : April 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources




Biospecimen Retention:   None Retained
Sputum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: April 2011

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

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