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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00809094
• Date of registration: 15/12/2008
• Prospective Registration: No
• Primary sponsor: Stanford University
• Public title: 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
• Scientific 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
• Date of first enrolment: November 2008
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00809094
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Carol K. Conrad
• Affiliation: Stanford University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female 7 years of age or older

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 > 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)

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



Age minimum: 7 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Placebo

Drug: N-acetylcysteine (NAC)

Primary Outcome(s)

Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum [Time Frame: From enrollment to end of the 24-week trial]

Secondary Outcome(s)

FEF 25-75% (Percent of Predicted) [Time Frame: Baseline to 24 weeks]

FEV1 (L) [Time Frame: Baseline to end of study (24 weeks)]

Change in FEV1 (Percent of Predicted for Age) [Time Frame: From enrollment to the end of the 24-week trial]

FEF 25-75% (L/Sec) [Time Frame: Baseline to end of study (24 weeks)]

Secondary ID(s)

SU-12112008-1378

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation Therapeutics

Results

• Results available: Yes
• Date Posted: 15/03/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00809094