Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multi-centre, Long-term Comparative Trial of High Frequency Chest Wall Oscillation Versus Positive Expiratory Pressure Mask in the Treatment of Cystic Fibrosis
Brief Summary: This study is a preliminary study designed to determine the safety and effectiveness of HFCWO using the InCourage vest system as an airway clearance technique for the treatment of CF. The study will compare HFCWO to the most commonly used airway clearance technique in Canada, namely the Positive Expiratory Pressure technique in patients with CF over a period of one year. As this is a preliminary study, it will not be able to determine if the vest is equivelant to PEP, but will provide the information needed to plan a larger study to answer that question.


Options:
A: 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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B: Inclusion Criteria:

1. Diagnosis of CF established by sweat chloride \> 60 mmol/L.
2. Age older than 18 years.
3. History of chronic daily sputum production.
4. Currently on a home therapeutic regimen that includes some form of BD performed at least 2 times daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
5. FVC and FEV1 \> 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 4 months).
6. Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12 months.

Exclusion Criteria:

1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
2. Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment.
3. Chronic chest pain.
4. Participation in another clinical trial in the previous 30 days.
5. Use of intravenous antibiotics in the 2 months preceding enrollment.
C: Inclusion Criteria:

* Male or female 6 years of age or older at enrollment and be competent in performing spirometry.
* Confirmed diagnosis of CF.
* FEV1\> 45% predicted as calculated by Wang reference equations
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
* Clinically stable at enrollment with no evidence of respiratory exacerbation within a month of enrollment as assessed by the site CF Physician.
* Willingness to adhere to prescribed treatment regimen.

Exclusion Criteria:

* Diagnosis of Allergic Broncho-Pulmonary Aspergillosis, or a persistent culture for B.cepacia complex within the previous 1 year period
* .On active treatment for non Tuberculous Mycobacterium.
* Use of intravenous antibiotics within the previous 14 days of enrollment.
* Initiation and or change in maintenance therapy within 14 days of enrollment.
* Use of systemic corticosteriods (1mg/kg if \< 20 kg or 20 mg of prednisone per day) within 14 days of enrollment.
* Concurrent participation in another study that could potentially affect the present study.
* Haemoptysis of over 20 mls on more than 2 occasions within the previous 30 days from enrollment.
* A pneumothorax in the six months preceding the study.
* Presence of a condition or abnormality that in the opinion of the site CF Physician would compromise the safety of the patient or the quality of the data.
D: Inclusion Criteria:

1. Diagnosis of CF established by sweat chloride \> 60 mmol/L.
2. Age older than 18 years.
3. History of chronic daily sputum production.
4. Currently on a home therapeutic regimen that includes some form of airway clearance performed with a HFCWO device at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
5. FVC and FEV1 \> 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).
6. Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12 months.

Exclusion criteria:

1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
2. Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment.
3. Chest pain requiring use of narcotic for pain control.
4. Current participation in another clinical trial.
5. Use of intravenous antibiotics for CF respiratory complications in the 2 months preceding enrollment.
6. No prior experience using HFCWO devices for airway clearance

Answer: C