Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Brief Summary: The purpose of this study was to support the selection of a safe and tolerable tobramycin inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P. aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa colonization.


Options:
A: 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.
B: Key Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Male and female patients of ≥ 18 years of age at screening (Visit 1).
* Proven diagnosis of non-CF BE as documented by computed tomography or high-resolution computed tomography
* At least 2 or more exacerbations treated with oral antibiotics OR 1 or more exacerbation requiring intravenous antibiotic treatment within 12 months prior to screening.
* FEV1 ≥ 30% predicted at screening (Visit 1).
* P. aeruginosa, must be documented in a respiratory sample at least 1 time within 12 months and also present in the expectorated sputum culture at Visit 1.

Key Exclusion Criteria:

* Patients with a history of cystic fibrosis.
* Patients with a primary diagnosis of bronchial asthma.
* Patients with a primary diagnosis of COPD associated with at least a 20 pack year smoking history.
* Any significant medical condition that is either recently diagnosed or was not stable during the last 3 months, other than pulmonary exacerbations, and that in the opinion of the investigator makes participation in the trial against the patients' best interests.
* Clinically significant (in the opinion of the investigator) hearing loss that interferes with patients' daily activities (such as normal conversations) or chronic tinnitus. Patients with a past history of clinically significant hearing loss in the opinion of the investigator may be eligible only if their hearing threshold at screening audiometry is 25dB or lower at frequencies 0.5-4 kHz. The use of a hearing device is reflective of a clinically significant hearing loss; hence patients using hearing aids at screening are not eligible.
* Patients with active pulmonary tuberculosis.
* Patients currently receiving treatment for nontuberculous mycobacterial (NTM) pulmonary disease.
* Patients who are regularly receiving inhaled anti-pseudomonal antibiotic (during the study inhaled anti-pseudomonal antibiotics are not allowed other than the study drug).
C: Inclusion Criteria:

* Confirmed diagnosis of non-CF bronchiectasis
* History of P. aeruginosa respiratory infections
* At least two pulmonary exacerbations treated with antibiotics in the previous year

Exclusion Criteria:

* Have a clinical diagnosis of CF
* Are pregnant
D: Inclusion Criteria:

* Patients with a proven and documented diagnosis of non Cystic Fibrosis (CF) idiopathic or post infectious bronchiectasis
* Stable pulmonary status and stable regimen of standard treatment at least for the past 4 weeks

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1) \<30% or \>90% predicted
* Active allergic bronchopulmonary aspergillosis
* Active and actively treated non tuberculosis mycobacterial (NTM) infection or tuberculosis
* Primary diagnosis of Chronic obstructive pulmonary disease (COPD)

Answer: B