Status:
COMPLETED
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
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
7+ years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Male or female 7 years of age or older
- Diagnosis of CF based upon the following criteria:
- One or more clinical features characteristic of CF AND (b or c)
- Positive sweat test \> 60 mEq/L by quantitative pilocarpine iontophoresis
- A genotype with two identifiable mutations consistent with CF
- Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
- Clinically stable with no evidence of acute upper or lower respiratory tract infection within 4 weeks prior to enrollment
- 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
- Able to tolerate sputum induction with 3% hypertonic saline and to expectorate
- Able to perform repeatable, consistent efforts in pulmonary function testing
- Weight \> or = 25 kg at time of enrollment
- Females of child bearing potential must be willing to use birth control (IUD, oral, transdermal, or parenteral contraceptives; abstinence)
Exclusion
- Clinically significant liver enzymes (AST, ALT or GGT) \> 2.5 times the upper limit of normal at screening
- History of ABPA, unless have evidence of a stable IgE (\< 5% increase compared to previous test) for 6 months prior to enrollment
- Current or history of rheumatic or collagen vascular disorders
- Use of NSAIDS other than for chronic therapy within 1 week prior to enrollment
- Initiation of chronic therapy with ibuprofen, azithromycin, TOBI® or Aztreonam within 6 weeks prior to enrollment
- Consumption or inhalation of antioxidants (including NAC, GSH, Immunocal, Nacystelyn, pentoxyfilline) within 6 weeks prior to enrollment
- Use of oral or IV corticosteroids within 4 weeks prior to enrollment
- Use of acetaminophen within 3 days prior to enrollment
- 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
- Known hypersensitivity to oral PharmaNAC®
- Current cigarette consumption
- Pregnant or breastfeeding
- Subject unlikely to complete the study as determined by the Investigator
- 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
- Participation in trials for other anti-inflammatory or therapeutic investigational drugs within 6 weeks prior to enrollment
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00809094
Start Date
November 1 2008
End Date
February 1 2011
Last Update
April 22 2013
Active Locations (11)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Stanford University School of Medicine
Stanford, California, United States, 94305
3
National Jewish Hospital
Denver, Colorado, United States
4
Yale New Haven Hospital
New Haven, Connecticut, United States