Determination of the in Vitro Effects of Cationic Airway Lining Modulators (CALM) on Chronic Obstructive Pulmonary Disease (COPD) Sputum
1 other identifier
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2010
CompletedFirst Posted
Study publicly available on registry
March 30, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedApril 11, 2011
April 1, 2011
2 months
March 25, 2010
April 7, 2011
Conditions
Keywords
Eligibility Criteria
Outpatient clinic setting
You may qualify if:
- 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.
You may not qualify if:
- a primary diagnosis of asthma or bronchiectasis
- a COPD exacerbation within 4 weeks
- Inability to comply with study procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pulmatrix Inc.lead
- The VA Western New York Healthcare Systemcollaborator
- Buffalo Institute For Medical Researchcollaborator
Study Sites (1)
VA WNY Healthcare System
Buffalo, New York, 14215, United States
Biospecimen
Sputum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Sethi, MD
Va Western NY Healthcare, Buffalo Institute for Medical Research
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 25, 2010
First Posted
March 30, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2010
Study Completion
October 1, 2010
Last Updated
April 11, 2011
Record last verified: 2011-04