Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Brief Summary: This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).


Options:
A: Inclusion Criteria:

* Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of \>70mmol/l or sweat chloride of \>60mmol/l)
* Sixteen years of age or over
* Patients admitted to the Royal Brompton Hospital with a pulmonary exacerbation of which is resolving. Patients will be considered for inclusion from day 7 of treatment to 3 days prior to discharge (as determined by a member of the cystic fibrosis medical team and have spirometric values within 20% of the mean of the last two stable recordings (at least 1 month apart)
* Patients with an established airway clearance regime that they have used for 3 months or more

Exclusion Criteria:

* Current moderate haemoptysis (greater than streaking in the sputum)
* Current pneumothorax or history of pneumothorax in the 3 months prior to consideration for the study
* Current dependency on positive pressure support with airway clearance via the IPPB (Intermittent Positive Pressure Breathing) machine or NIV
* Previous history of spontaneous rib fractures
* Pregnancy
* Inability to give consent for treatment or measurement
* Current participation in another study
* If the patient requires more than 2 airway clearance sessions a day
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:

* Diagnosis of cystic fibrosis
* Hospitalised patients admitted with a pulmonary infection
* Forced expiratory volume in one second (FEV1)of 15% predicted or over
* 16 years of age or over

Exclusion Criteria:

* Current severe haemoptysis
* Rib fractures or history of spontaneous rib fractures
* pregnancy
* Lung abscess
* End stage disease
* Requiring more than two assisted treatment sessions per day
* Requiring treatment with positive pressure
* Inability to give consent
D: Inclusion Criteria:

1. Male or female patients with a documented diagnosis of CF aged ≥18 years.
2. Written informed consent.
3. At least day 10 - 14 of IV antibiotic therapy during a hospital admission for a pulmonary exacerbation.
4. Patients must be able to perform acceptable spirometric manoeuvres, according to the American Thoracic Society/ERS (ATS/ERS) standards (Miller, Hankinson et. al. 2005).
5. Patient with an FEV1% predicted of ≥ 40%predicted (Stanojevic, Wade et al. 2008).
6. Patients who are productive of sputum from screening visit to study visit 1 (≥10g over 24 hours).
7. Patients who have been prescribed HTS (Nebusal 7%) and have successfully completed a challenge test.
8. Any other chronic medication must have commenced therapy 4 weeks prior to screening and be willing to continue this therapy for the entire duration of the study.

Exclusion Criteria:

1. Day 1-9 of IV antibiotic therapy during a hospital admission.
2. Patients who are colonized with Burkholderia cepacia complex.
3. Patient who are HTS naive.
4. Patients who have an intolerance to HTS.
5. Patients who are currently participating in another study or have participated in another study with an investigational drug within one month of screening.
6. Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.

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Answer: B