Please select the eligibility criteria that correspond to the clinical trial below.
Title: Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)
Brief Summary: The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.


Options:
A: Inclusion Criteria:

* Diagnosis of CF as defined by clinical features of CF and a documented sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
* Informed consent and verbal assent (as appropriate) has been provided by the subject's parent or legal guardian and the subject
* 6-18 years of age at enrolment
* Able to perform reproducible spirometry
* Clinically stable at enrolment
* Ability to comply with medication use, study visits and study procedures as judged by the site investigator
* FEV1 % predicted \> 70 % as calculated by the Wang reference equations

Exclusion Criteria:

* Respiratory culture positive for:

  * NTM within past year or AFB positive at screening (sputum only)
  * B. cepacia complex within past year or at screening
* Use of intravenous antibiotics or oral quinolones within 14 days of screening
* Investigational drug use within 30 days of screening
* History of alcohol, illicit drug or medication abuse within 1 year of screening
* Other major organ dysfunction excluding pancreatic dysfunction
* History of lung transplantation or currently on lung transplant list
* Physical findings at screening that would compromise the safety of the participant or the quality of the study data
B: Inclusion Criteria:

1. Diagnosis of CF as evidenced by one or more clinical features consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:

   1. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
   2. A documented genotype with two disease-causing mutations in the CFTR gene
2. Informed consent by parent or legal guardian
3. Age ≥ 36 months and ≤72 months at screening visit
4. Ability to comply with medication use, study visits and study procedures as judged by the site investigator
5. Ability to cooperate with chest CT at the enrollment visit as determined by the lung function technician

Exclusion Criteria:

1. Chest CT within 8 months prior to the Screening visit
2. Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding screening or enrollment visit
3. Acute wheezing at screening or enrollment visit
4. Oxygen saturation \< 95% (\<90% in centers located above 4000 feet elevation) at screening or enrollment visit
5. Other major organ dysfunction, excluding pancreatic dysfunction
6. Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
7. Investigational drug use within 30 days prior to screening or enrollment visit
8. Treatment with inhaled HS at any concentration within 30 days prior to screening or enrollment visit
9. Initiation (i.e. new prescription) of any inhaled hydrating agent such as mannitol or mucolytic agents such as dornase alpha within 30 days prior to the screening or enrollment visit
10. Chronic lung disease not related to CF
11. Inability to tolerate first dose of study treatment at the enrollment visit
C: Inclusion Criteria:

* Clinical and laboratory diagnosis of cystic fibrosis
* Age greater than or equal to 5 years
* Forced expiratory volume in 1 second (FEV1) greater than or equal to 40% predicted
* Sinus surgery within one week of enrollment

Exclusion Criteria:

* Pregnancy
* Intolerance of orally inhaled Pulmozyme (dornase alfa)
D: Inclusion Criteria:

* Subjects with CF (medical record evidence of CFTR(Cystic fibrosis transmembrane conductance regulator) mutation or sweat chloride test or nasal voltage difference, and 1 or more clinical findings of CF),
* Age 12 or greater
* FEV1 \> 30% predicted(within the last 14 days and oxygen saturation \> 90% on FiO2(fraction of inspired oxygen) ≤ 50%,
* Admitted for an exacerbation,
* Use of effective contraception in women,
* Able to provide written informed consent.

Exclusion Criteria:

* Pregnancy,
* History of asthma based on methacholine challenge or bronchial hyperresponsiveness on PFTS(Pulmonary Function Test),
* Hemoptysis more than 60 mL within the last 30 days,
* Use of any investigational study drug within the last 30 days,
* Initiation of hypertonic saline within the last 30 days,
* A serum creatinine 2 mg/dl or more
* Active malignancy in the last year
* Antibiotics for CF exacerbation as an outpatient in the last 2 weeks
* B cepacia colonization
* Waiting list for lung transplant
* Lack of FEV1 data from the last 14 days
* Previous participation in this study

Answer: B