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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758771
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
Genentech, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease
Cystic Fibrosis

Detailed Description:
There are two major mechanisms for mucus clearance in the airway, both of which are dependent upon optimal mucus viscosity and elasticity. These mechanisms are severely impaired in cystic fibrosis. The physical properties of sputum can be measured using rheological methods, enabling comparison between mucus in health and in disease. Therapies which enhance mucus clearance from the airway and decrease the volume of airway secretions are collectively called "mucoactive agents." Therapies which specifically disrupt innate mucus architecture by breaking intermolecular entanglements and bonds are called mucolytic agents. Mucolytic drugs can be considered in three general categories: classic mucolytics (n-acetylcysteine), peptide mucolytics (Pulmozyme®), and non-destructive mucolytics (hypertonic saline). Using state-of-the-art rheological methods, we can characterize the physical properties of CF mucus and measure the rheologic effects of mucoactive drugs more accurately and reproducibly than what has been previously done in the literature. In this way, we will determine which of the current mucoactive agents are most effective in normalizing sputum rheology in CF, and we will gain important insights about the limitations of current mucoactive drugs.

Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Using State-of-the-art Rheological Methods to Characterize CF Sputum and the Effects of Mucoactive Agents: A Pilot Study
Study Start Date : October 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Cystic Fibrosis
People who have been diagnosed with cystic fibrosis
People who do not have cystic fibrosis and who do not have any other lung conditions

Primary Outcome Measures :
  1. Shear Rheology [ Time Frame: Cross-sectional ]
    Baseline measure of sputum shear rheology

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
People who have cystic fibrosis and those who do not have any lung disease

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 identifier (NCT number): NCT00758771

United States, California
UCSF Airway Clinical Research Center
San Francisco, California, United States, 94143-0130
Sponsors and Collaborators
University of California, San Francisco
Genentech, Inc.

Additional Information:
Responsible Party: University of California, San Francisco Identifier: NCT00758771     History of Changes
Other Study ID Numbers: 10-02116
First Posted: September 25, 2008    Key Record Dates
Results First Posted: March 5, 2014
Last Update Posted: March 5, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases