Using Rheological Methods to Characterize Cystic Fibrosis (CF) Sputum and the Effects of Mucoactive Agents

NCT00758771 | Completed Results

• 1 other identifier: 10-02116
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the rheological properties of cystic fibrosis (CF) and healthy sputum and to examine the effects of mucoactive agents on the rheology of CF and healthy sputum. By collaborating with Genentech, the investigators (scientists at UCSF) plan to incorporate the latest scientific findings into our work to discover and develop new treatments for CF.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Shear Rheology

  Baseline measure of sputum shear rheology

  Cross-sectional

Study Arms (2)

Cystic Fibrosis

People who have been diagnosed with cystic fibrosis

Healthy

People who do not have cystic fibrosis and who do not have any other lung conditions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who have cystic fibrosis and those who do not have any lung disease

You may qualify if:

• Healthy control subjects:
• Age 18-65
• No history of lung disease or cardiac disease
• Cystic fibrosis subjects:
• Age 18-65
• Diagnosis of CF - sweat chloride values \> 60 mM on pilocarpine iontophoresis sweat tests and/or 2 allelic CF-producing mutations by genetic analysis

You may not qualify if:

• Use of recreational drugs within 1 year prior to enrollment
• Use of tobacco within 1 year prior to enrollment, or \> 10 pack-year tobacco history
• Upper respiratory tract infection in the 4 weeks prior to enrollment in the study
• Current use of antihistamines to treat allergies

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator

Study Sites (1)

UCSF Airway Clinical Research Center

San Francisco, California, 94143-0130, United States

Location

Related Links

• UCSF Airway Clinical Research Center website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sputum

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: John V. Fahy, MD, MSc
• Organization: UCSF

john.fahy@ucsf.edu

4154769940

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 25, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 5, 2014
• Results First Posted: March 5, 2014

Record last verified: 2014-01

Locations

US (1)