Back to resultsDetermination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Chronic Obstructive Pulmonary Disease focused on measuring Sputum, chronic obstructive pulmonary disease
Eligibility Criteria
Inclusion Criteria:
- Clinical and spirometric diagnosis of COPD
- Smoking history of at least 10 pack yrs
- Sputum production of greater than 2 tablespoons per day by patient report.
Exclusion Criteria:
- a primary diagnosis of asthma or bronchiectasis
- a COPD exacerbation within 4 weeks
- Inability to comply with study procedures.
Sites / Locations
- VA WNY Healthcare System
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01096173
First Posted
March 25, 2010
Last Updated
April 7, 2011
Sponsor
Pulmatrix Inc.
Collaborators
The VA Western New York Healthcare System, Buffalo Institute For Medical Research
1. Study Identification
Unique Protocol Identification Number
NCT01096173
Brief Title
Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum
Official Title
Determination of the in Vitro Effects of CALM on COPD Sputum
Study Type
Observational
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pulmatrix Inc.
Collaborators
The VA Western New York Healthcare System, Buffalo Institute For Medical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Sputum, chronic obstructive pulmonary disease
7. Study Design
Enrollment
10 (Anticipated)
Biospecimen Retention
None Retained
Biospecimen Description
Sputum samples
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and spirometric diagnosis of COPD
Smoking history of at least 10 pack yrs
Sputum production of greater than 2 tablespoons per day by patient report.
Exclusion Criteria:
a primary diagnosis of asthma or bronchiectasis
a COPD exacerbation within 4 weeks
Inability to comply with study procedures.
Study Population Description
Outpatient clinic setting
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Sethi, MD
Organizational Affiliation
Va Western NY Healthcare, Buffalo Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA WNY Healthcare System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum
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