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NAC Phase IIB: 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
This study is currently recruiting participants.
Verified by Stanford University, December 2008
Sponsors and Collaborators: Stanford University
Cystic Fibrosis Foundation
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00809094
  Purpose

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

Genetics Home Reference related topics: cystic fibrosis
MedlinePlus related topics: Cystic Fibrosis
Drug Information available for: Acetylcysteine
U.S. FDA Resources
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

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • change in the logarithm of the level of human neutrophil elastase (HNE) activity measured in sputum from enrollment to the end of the 24-week trial

Secondary Outcome Measures:
  • change in concentration of IL-8 measured in sputum and plasma, change in concentration of glutathione (GSH) measured in whole blood, and change in the neutrophil count measured in sputum from enrollment to the end of the 24-week trial

Estimated Enrollment: 80
Study Start Date: November 2008
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Inclusion Criteria

  1. Male or female ≥ 7 years of age
  2. Diagnosis of CF based upon the following criteria:

    1. One or more clinical features characteristic of CF AND (b or c)
    2. Positive sweat test > 60 mEq/L by quantitative pilocarpine iontophoresis
    3. A genotype with two identifiable mutations consistent with CF
  3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
  4. Clinically stable with no evidence of acute upper or lower respiratory tract infection within 4 weeks prior to enrollment
  5. Stable mild or moderately severe lung disease defined by an FEV1 &#8805; 40% and &#8804; 85% predicted for age based on the Wang (males < 18 years, females < 16 years) or Hankinson (males &#8805; 18 years, females &#8805; 16 years) standardized equations
  6. Able to tolerate sputum induction with 3% hypertonic saline and to expectorate
  7. Able to perform repeatable, consistent efforts in pulmonary function testing
  8. Weight &#8805; 25 kg at time of enrollment
  9. Females of child bearing potential must be willing to use birth control (IUD, oral, transdermal, or parenteral contraceptives; abstinence)&#xA; Exclusion Criteria:Exclusion 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:

  • Vitamin E: more than 400 IU/day for subjects &#8804; 12 years of age and 800 IU/day for subjects > 12 years of age
  • Vitamin C: more than 0.5 gm/day
  • More than two alcoholic drinks per day 10. Known hypersensitivity to oral PharmaNAC® 11. Current cigarette consumption 12. Pregnant or breastfeeding 13. Subject unlikely to complete the study as determined by the Investigator 14. Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject 15. Participation in trials for other anti-inflammatory or therapeutic investigational drugs within 6 weeks prior to enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809094

Locations
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            
Sponsors and Collaborators
Stanford University
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Carol K. Conrad Stanford University
  More Information

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009