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

Status: Completed
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: No
View:

• 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)

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
California
Stanford University School of Medicine
Stanford
Colorado
National Jewish Hospital
Denver
Connecticut
Yale New Haven Hospital
New Haven
Florida
Shands at the University of Florida
Gainesville
North Carolina
Duke Children
Durham
New York
Columbia University Medical Ctr
New York
Pennsylvania
The PennState Milton S Hersey Medical Ctr
Hershey
The Children
Philadelphia
Children
Pittsburg
Utah
University of Utah, Primary Children
Salt Lake City
Time Frame
Start Date: November 2008
Completion Date: February 2011
Participants
Target number of participants: 70
Treatments
Placebo Comparator: Placebo
Placebo was administered oral tablet TID for 24 weeks.
Active Comparator: N-Acetylcysteine
Participants received 900 mg of oral N-acetylcysteine TID for 24 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Cystic Fibrosis Foundation
Leads: Stanford University

This content was sourced from clinicaltrials.gov

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