Carol Conrad
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
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: N-acetylcysteine (NAC)
Phase:
Phase 2Eligibility
Ages Eligible for Study:
7 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion Criteria
1. Male or female 7 years of age or older
2. Diagnosis of CF based upon the following criteria:
a. One or more clinical features characteristic of CF
AND (b or c)
b. Positive sweat test > 60 mEq/L by quantitative pilocarpine iontophoresis
c. 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 > or = 40% and < or = 85% predicted for age based on the Wang (males < 18 years, females < 16 years) or Hankinson (males > or = 18 years, females > or = 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 > or = 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)
Key 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 < or = 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
Additional Study Details
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 PatientsAnticipated start date:
11/3/2008Lead Sponsor:
Stanford UniversityCollaborator(s):
- Cystic Fibrosis Foundation
Investigator(s):
- Carol K. Conrad
- Richard B Moss
- Carlos Milla
- Terry Earl Robinson
- Paul K Mohabir
- John David Mark
- Colleen Dunn RCP
- Zoe Davies RN
- Martha Hamilton
- Rabin Tirouvanziam PhD
- Dr. Jacquelyn Marie Zirbes DNP
- Yan Ki Angela Leung
- Andrea Core
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
EfficacyPrimary Outcomes:
- change in the logarithm of the level of human neutrophil elastase (HNE) activity measured in sputum
Secondary Outcomes:
- 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
Total Number to be Enrolled:
80Total Number to be Enrolled at Stanford:
16More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
10/20/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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