Determination of the in Vitro Effects of Cationic Airway... | NCT01096173

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

NCT01096173

Sponsor

Pulmatrix Inc.

Status

Completed

Last Update Posted

Apr 11, 2011Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Oct 2010Actual

First Submitted Date

Mar 25, 2010

First Submission Date that Met QC Criteria

Mar 29, 2010

First Posted Date

Mar 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2011

Last Update Posted Date

Apr 11, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Pulmatrix Inc.INDUSTRY

Collaborators

Name	Class
The VA Western New York Healthcare System	FED
Buffalo Institute For Medical Research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

10Estimated

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Outpatient clinic setting

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sanjay Sethi, MD	Va Western NY Healthcare, Buffalo Institute for Medical Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA WNY Healthcare System		Buffalo	New York	14215	United States

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

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Browse Branches

Not provided