Please select the eligibility criteria that correspond to the clinical trial below.
Title: Azithromycin Treatment of Patients With Chronic Obstructive Pulmonary Disease (COPD) and Tracheostomy. Effects on Recurrent Respiratory Infections, Inflammatory Parameters and Bacterial Persistence
Brief Summary: Aims of the study

* to evaluate the rate of enteric gram negative bacteria colonization in tracheotomised COPD patients
* to evaluate the effect of azithromycin long-term treatment on Pseudomonas aeruginosa colonization and colony counts, and on reduction of the number of exacerbations/hospitalisations, antibiotic courses and steroid use.
* to evaluate the Quality of Life of patients treated and not treated with azithromycin, using a validate Italian version of St George questionnaire
* to evaluate the rate of chronic colonization with atypical pathogens
* to evaluate the safety and tolerability of a long-term treatment with azithromycin, including a survey on possible bacterial antibiotic resistance pattern variations


Options:
A: Inclusion Criteria:

* GOLD II or III COPD (GOLD II: FEV1/FVC \< 70%; 50% \< FEV1 \< 80% predicted, GOLD III: FEV1/FVC \< 70%; 30% \< FEV1 \< 50% predicted ).
* Stable disease (no exacerbations in the last 3 months).
* Age \> 40 yrs.
* Written informed consent.

Exclusion Criteria:

* Infections and/or use of antibiotics in the last month.
* Bacterial colonization of the airways, proven by sputum cultures or broncho-alveolar lavage (BAL).
* Allergy for tetracyclines or a history of substantial side-effects.
* Active respiratory diseases other than COPD (e.g. sarcoidosis, tuberculosis, lung cancer, bronchiectasis).
* Acute exacerbation of COPD as defined by Anthonisen et al. \[10\].
* Signs and/or symptoms of a current respiratory or non-respiratory infection.
* Use of oral or intravenous corticosteroids or other immunosuppressive drugs within the last month.
B: Inclusion Criteria:

* Age \> 45 years Tracheotomy History of COPD demonstrated by pulmonary function tests Informed Consent

Exclusion Criteria:

* Allergy to macrolides Life expectancy \< 1 year
C: Inclusion Criteria:

* Clinical Diagnosis of COPD
* Clinically stable for 6 weeks
* Able to Swallow Tablets

Exclusion Criteria:

* Clinically significant respiratory disease other than COPD
* Women of child bearing age
* Patients receiving existing Medication which may interact adversely with trial drug
* History of clinically significant liver disease
D: * Key Inclusion Criteria: List primary criteria for study inclusion (i.e. do not need to enter entire list of inclusion criteria).

  1. Patient must be 50 years old or older.
  2. Patient must have a smoking history of at least 20 pack-years
  3. Patient must have stable COPD, GOLD 0, I and/or IIA.
  4. CT of chest with evidence of emphysema
* Key Exclusion Criteria: List primary criteria for study exclusion (i.e. do not need to enter entire list of inclusion criteria).

  1. FEV1 \< 70%.
  2. Exacerbations (defined as use of oral steroids or antibiotics) in the previous month.
  3. Cardiovascular Disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
  4. Diabetes mellitus
  5. Renal disease
  6. Liver disease
  7. Lung cancer
  8. ETOH use of more than \>6 beers \>4 mixed drinks daily

Answer: B