Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Colorado, Denver
With
Cystic Fibrosis Foundation
Yasoo Health
Age
10–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female ≥10 years of age
Documentation of a Cystic Fibrosis (CF) diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:
* Sweat chloride equal to or greater than 60 milliequivalent (mEq/L) by quantitative pilocarpine iontophoresis test (QPIT)
* 2 well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Pancreatic insufficiency documented by having a spot fecal elastase-1 (FE-1) ≤ 100μg/g in a stool sample done either historically or at the screening visit
Clinically stable with no significant changes in health status within 2 weeks prior to randomization
Forced expiratory volume over one second (FEV1) ≥ 40 and ≤ 100% of predicted for age based on the Wang (males \< 18 years,females \< 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized equations at the screening visit
Weight ≥ 30 kg at the screening visit
Able to perform repeatable, consistent efforts in pulmonary function testing
Able to tolerate sputum induction with 3% hypertonic saline and to expectorate with induction
Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
Ability to swallow softgel capsules
You may not be if
Subjects being treated with ivacaftor (Kalydeco™)
Liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyl transferase (GGT) \> 3 times the upper limits of normal at the screening visit
Use of antibiotics (oral, iv, and/or inhaled) for acute respiratory symptoms within 2 weeks prior to randomization
Active treatment for allergic bronchopulmonary aspergillosis (ABPA)
Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day
Active treatment for nontuberculous mycobacterial (NTM) infection
Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline,azithromycin,Tobramycin Inhalation solution (TOBI®), Cayston® within 8 weeks prior to randomization
Unwilling to discontinue current oral vitamin and antioxidant supplementation (e.g.,AquADEKs®, another source of β-carotene, vitamin A, vitamin E or tocopherols,vitamins D or K, n-acetylcysteine, glutathione, CoQ10, other over-the-counter antioxidant) for the duration of the study
Use of vitamins (other than control vitamin) or antioxidants within 4 weeks prior to randomization
Daily use of \> 2 cans of Boost or Pulmocare dietary supplement formulas
Known hypersensitivity to oral AquADEKs®
For women of child bearing potential:
1. positive pregnancy test at Visit 1 or at Visit 2, or
2. lactating or
3. unwilling to practice a medically acceptable form of contraception (acceptable forms of contraception: abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent)
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
Use of investigational therapies within 4 weeks prior to randomization
Current tobacco smoker
Current use of anticoagulant medications
Severe malnutrition based either on having a BMI less than the 5th percentile for subjects \< 18 years of age or a body mass index (BMI) less than 18 kg/m2 for subjects \> 18 years of age.
Subjects with poorly controlled CF-related diabetes on active insulin therapy, defined as having a Glycosylated Hemoglobin (HgbA1c) ≥ 7.5% at the most recent historic evaluation of HgbA1c
