Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise Training in Patients With Non-CF Bronchiectasis - a Multi-centre Randomized Controlled Trial
Brief Summary: The aim of this project is to examine the short and long term effects of an 8 week, twice weekly, outpatient exercise training program for people with bronchiectasis. Participants will be randomly allocated to undergo a supervised exercise training program at The Alfred, Austin Hospital or Sir Charles Gairdner Hospital.

The hypotheses of this study are:

1. Patients with bronchiectasis who complete an exercise program will have a higher exercise capacity and better quality of life and these improvements will be sustained for up to 12 months after completion
2. Exercise training will significantly reduce the incidence of pulmonary exacerbations, use of antibiotics and rate of hospitalisation


Options:
A: Inclusion Criteria

1. Have given written informed consent to participate in this study in accordance with local regulations
2. Have documented evidence of confirmed diagnosis of (non-cystic fibrosis) bronchiectasis by computed tomography (CT), High resolution computed tomography (HRCT) or bronchogram
3. Be aged 18 - 85 years inclusive, male and female
4. Have FEV1 (Forced expiratory volume in one second) ≥ 40% and ≤85% predicted\* and ≥1.0L (\*according to NHANES III predicted tables) measured at Visit 0A (V0A)
5. Clinician documented history of at least 2 pulmonary exacerbations, each requiring antibiotic therapy, in the last 12 months prior to Visit 0A (V0A) and a total of at least 4 in the last 2 years prior to Visit 0A
6. Have a total SGRQ (St George's respiratory questionnaire) score of ≥30 at Visit 0B (V0B)
7. Have a production of ≥10g of sputum at Visit 0B Have reported chronic sputum production of ≥1 tablespoon (15mL) per day on the majority of days in the 3 months prior to Visit 0A
8. Be able to perform all the techniques necessary to measure lung function
9. Have FEV1 ≥40% predicted\* and ≥1.0L (\*according to NHANES III 1999 predicted tables) measured at V0B (Baseline result prior to MTT (Mannitol Tolerance Test) administration)

Exclusion Criteria

1. Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
2. Have bronchiectasis as a consequence of cystic fibrosis or focal endobronchial lesion or otherwise curable causes (e.g. foreign body aspiration)
3. Be considered "terminally ill" or listed for transplantation
4. Be using hypertonic saline in the 14 days prior to commencing Visit 0B or thereafter at any time during the study
5. Have previously used inhaled mannitol (Bronchitol) for more than a day
6. Have had a significant episode of hemoptysis (\>60 mL) in the previous 6 months
7. Have had rescue antibiotics in the 4 weeks prior to V0B (chronic background antibiotic therapy accepted)
8. Have smoked within the last 3 months and must not smoke during their participation in the study
9. Have had a myocardial infarction in the three months prior to Visit 0A
10. Have had a cerebral vascular accident in the three months prior to Visit 0A
11. Have had major ocular surgery in the three months prior to Visit 0A
12. Have had major abdominal, chest or brain surgery in the three months prior to Visit 0A
13. Have a known cerebral, aortic or abdominal aneurysm
14. Have actively treated Mycobacterium tuberculosis
15. Have actively treated or unstable nontuberculous mycobacterial (NTM)infection or be under consideration for NTM treatment in the next 12 months
16. Have unstable Allergic bronchopulmonary aspergillosis (ABPA) requiring steroid therapy (≤5mg dose oral steroids in stable ABPA accepted)
17. Have end stage interstitial lung disease
18. Have active malignancy including melanoma (other skin carcinomas exempted). Remissions from any malignancy ≥2 years also exempted
19. Be breast feeding or pregnant, or plan to become pregnant while in the study
20. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
21. Be participating in another investigational drug study, parallel to, or within 4 weeks of Visit 0A
22. Have a known intolerance to mannitol or β2-agonists
23. Have uncontrolled hypertension - e.g. for adults: systolic blood pressure (BP) \> 190 and or diastolic BP \> 100
24. Subject has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
25. Have previously been screen failed for the study (exceptions - see section 3.3.2 Eligibility Criteria - Rescreening)
B: Inclusion Criteria:

* Diagnosis of bronchiectasis (HRCT)
* Stable medical status for last 4 weeks
* History of 2 exacerbations in the last 2 years
* Dysnpoea on exertion (Modified Medical Research Council score \>1)

Exclusion Criteria:

* Concurrent diagnosis of COPD (physician diagnosis and history of 10 pack year smoking)
* Concurrent diagnosis of asthma (history of atopic disease and evidence of bronchodilator reversibility of 12% or 200ml in FEV1 or FVC)
* Concurrent diagnosis of Interstitial lung disease
* Concurrent diagnosis of Cystic Fibrosis
* Medical condition which could place patient at risk during exercise training (angina, neurological or orthopaedic condition)
* Prior completion of pulmonary rehabilitation within the last 12 months
C: Inclusion Criteria:

* Bronchiectasis confirmed by HRCT of the chest
* Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study start date)
* Aged 18-70
* Chronic sputum production \> 5 mls for the majority of days in 3 months before enrolment
* Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst clinically stable
* At least two exacerbations in the past year
* Patients able to tolerate a nebulized gentamicin challenge
* FEV1 \> 30% predicted
* Smoking \< 20 pack year history and ex-smokers \>1 year.

Exclusion Criteria:

* Cystic fibrosis
* Emphysema on HRCT chest
* Thoracic surgery within the past 1 year
* Allergic bronchopulmonary aspergillosis
* Poorly controlled asthma ( \> 20% diurnal variation in peak expiratory flows despite treatment)
* Unstable angina or uncontrolled congestive cardiac failure
* Active malignancy
* Pregnancy or breast feeding
* Creatinine clearance \< 30 mls/minute
* Vestibular instability
* Previous documented intolerance to aminoglycosides
D: Inclusion Criteria:

* Male/Female 18 years or older with non-CF bronchiectasis
* Chronic sputum production on most days
* Positive sputum culture for gram-negative organisms
* Must have met lung function requirements

Exclusion Criteria:

* History of CF
* Hospitalized within 14 days prior to joining the study
* Previous exposure to AZLI
* Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study
* Must have met liver and kidney function requirements
* Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with activity and at night was allowed)
* Treatment for nontuberculous mycobacteria infection or active mycobacterium tuberculosis infection within 1 year of enrollment
* Other serious medical conditions.

Answer: B