Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to compare the tolerability and acceptability of a formulation containing Hypertonic saline 7% (HS) alone and a formulation containing HS and Hyaluronic acid 0.1% in a population of Cystic Fibrosis (CF) patients who already showed poor tolerance to HS.


Options:
A: Inclusion Criteria:

* Confirmed diagnosis of CF (sweat tests/genotype)
* The subject, or their legal guardian for children under 18 years old, must provide written informed consent.
* The subject must be in stable clinical condition at the time of and for a period of 14 days prior to their recruitment into the study.
* Age \> 6 years old
* FEV1 \> 40% predicted for height, age and gender
* Proven or anticipated compliance with therapy or study protocol
* Regular attendee at a Cystic Fibrosis Clinic (\> 2 visits per year)
* Able to reproducibly perform lung function tests (spirometry)
* Relatively stable nutritional status (\< 2 kg weight loss in last 6 months and \< 5 kg weight loss in last year)
* Known to have "normal" (for CF subject) laboratory tests - haematology, biochemistry, immunology, coagulation, etc.

Exclusion Criteria:

* Requiring home oxygen (pO2 \<55mmHg or pCO2 \>50mmHg) or assisted ventilation.
* Considered "terminally ill" or listed for transplantation (either lung or liver). Subjects that are listed for transplant after being enrolled in the trial are eligible to continue in the trial.
* Subjects colonised with Burkholderia cepacia. However, if a subject becomes colonised with B. cepacia during the trial, they should continue in the trial. Subjects should be considered to be B. cepacia positive if they have had even a single lifetime isolate. In these subjects, spirometry should be measured on a dedicated spirometer.
* Cigarette smoker.
* Exposure to investigational drugs within the past 30 days.
* Major haemoptysis (\> 60 mL in a single episode) within the last twelve months.
* Concurrent illnesses eg. cor pulmonale, clinically significant liver disease (portal hypertension, varices).
* Known allergy to quinine sulphate, Glucose 6-phosphate dehydrogenase deficiency.
* Immune thrombocytopaenic purpura.
* Pregnant or lactating females.
* At risk females unwilling to use appropriate contraception to prevent pregnancy for the duration of their enrolment in the study.
B: Inclusion Criteria:

* Pass the inhalation test
* Chronic sputum production, at least ≥ 10 ml /24h
* Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium\>70 mmol/l or sweat chloride of\>60 mmol/l)
* Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks)
* Trained in the use of autogenic drainage technique (at least 6 months)
* Inhaling hypertonic saline since at least 6 months
* To be able to provide written, informed consent and perform the protocol and the evaluations

Exclusion Criteria:

* Active massive hemoptysis during the previous 2 months
* Patient in transplantation or retransplantation list
* Patient already participating in another study at the same time
C: Inclusion Criteria:

* Subject has a confirmed diagnosis of cystic fibrosis based on: 2 positive sweat chloride tests and/or genetic characterization
* Subject is 8 years of age or older
* informed consent of the patient or legal representative
* Women of childbearing potential are only included into the study, if they are using an effective method of birth control during the protocol (failure rate \<1% e.g. implants, combined oral contraceptives, injectables, some intrauterine devices, sexual abstinence or vasectomised partner)

Exclusion Criteria:

* Subject has no chronic rhinosinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS-criteria)
* Subject has a critical condition defined as: forced expiratory volume at one second \< 30% and / or arterial oxygen saturation \< 93% without O2-substitution; need of O2-substitution
* Subject had an ENT surgery within 6 months prior to study
* Subject participates in another clinical trial within 30 days prior to study entry
D: Inclusion Criteria:

* diagnosis of Cystic Fibrosis (genotyping and sweat test)
* \> 8 year-old
* clinically and therapeutically stable disease in the last 30 days;
* Forced Expiratory Volume in one second (FEV1) ≥ 50% of predicted value;
* intolerance (cough, throat irritation, saltiness) to previous administration of 5.8% hypertonic saline solution.

Exclusion Criteria:

* decrease in FEV1 \>15% after first inhalation of hypertonic saline;
* Burkholderia cepacia infection;
* infective exacerbation requiring antibiotic treatment in the 15 days preceding enrolment;
* patient non compliant to standard therapy;
* Lung transplant;
* Patient unable to perform reproducible spirometry;
* Intolerance to β2 bronchodilators;
* Concurrent enrolment in other clinical trials;
* Plasmatic creatinine and transaminases more than twice the normal values.

Answer: D