Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Stanford University Cystic Fibrosis Foundation |
---|---|
Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00809094 |
This Phase IIB proof-of-concept study would examine the effects of an investigational product called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung disease. We hope to learn more about the causes of lung disease in cystic fibrosis by studying the characteristics of the inflammation in the lungs of patients who have CF.
Condition | Intervention | Phase |
---|---|---|
Cystic Fibrosis |
Drug: N-acetylcysteine (NAC) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Multi-Center, Phase IIB, Randomized, Placebo-Controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients |
Estimated Enrollment: | 80 |
Study Start Date: | November 2008 |
Ages Eligible for Study: | 7 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Inclusion Criteria
Diagnosis of CF based upon the following criteria:
1. Clinically significant liver enzymes (AST, ALT or GGT) > 2.5 times the upper limit of normal at screening 2. History of ABPA, unless have evidence of a stable IgE (< 5% increase compared to previous test) for 6 months prior to enrollment 3. Current or history of rheumatic or collagen vascular disorders 4. Use of NSAIDS other than for chronic therapy within 1 week prior to enrollment 5. Initiation of chronic therapy with ibuprofen, azithromycin, TOBI® or Aztreonam within 6 weeks prior to enrollment 6. Consumption or inhalation of antioxidants (including NAC, GSH, Immunocal, Nacystelyn, pentoxyfilline) within 6 weeks prior to enrollment 7. Use of oral or IV corticosteroids within 4 weeks prior to enrollment 8. Use of acetaminophen within 3 days prior to enrollment 9. Unable to forego during the study:
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Colleen Dunn 650-736-0388 cedunn@stanford.edu | |
Principal Investigator: Carol K. Conrad | |
Sub-Investigator: Daisy Carolina Diaz | |
Sub-Investigator: Yan Ki Angela Leung | |
Sub-Investigator: Dr. Jacquelyn Marie Zirbes DNP | |
Sub-Investigator: Rabin Tirouvanziam PhD | |
Sub-Investigator: Martha Hamilton | |
Sub-Investigator: Zoe Davies RN | |
Sub-Investigator: Colleen Dunn RCP | |
Sub-Investigator: John David Mark | |
Sub-Investigator: Paul K Mohabir | |
Sub-Investigator: Terry Earl Robinson | |
Sub-Investigator: Carlos Milla | |
Sub-Investigator: Richard B Moss |
Principal Investigator: | Carol K. Conrad | Stanford University |
Study ID Numbers: | SU-12112008-1378 |
Study First Received: | December 15, 2008 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00809094 |
Health Authority: | United States: Food and Drug Administration |
Fibrosis Inflammation Digestive System Diseases Cystic Fibrosis Respiratory Tract Diseases Genetic Diseases, Inborn Respiratory Tract Infections |
Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases Acetylcysteine Cystic fibrosis N-monoacetylcystine Pneumonia |
Respiratory System Agents Anti-Infective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antiviral Agents Protective Agents |
Pharmacologic Actions Pathologic Processes Expectorants Therapeutic Uses Free Radical Scavengers Antidotes |