Please select the eligibility criteria that correspond to the clinical trial below.
Title: Belgian Trial With Azithromycin During Acute COPD Exacerbations
Brief Summary: This project (funded by the IWT-TBM program) will organize a randomized placebo-controlled multicenter intervention trial in 500 COPD patients to study the effectiveness and safety of azithromycin therapy in the acute setting of COPD exacerbations requiring hospital admission. Although long-term use of azithromycin is proven effective to prevent exacerbations, inherent risks outweigh the benefits. By reducing the dose and duration of the azithromycin treatment and by restricting the treatment to acute periods with highest risk for treatment failure, benefits may counterbalance potential side effects, which may result in a new treatment strategy for these acute events.

The present study is designed by the services of respiratory medicine of the Leuven and Ghent University hospitals but will run in total in 17 different large hospitals in Belgium, of which 12 are located in Flanders.


Options:
A: 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
B: Inclusion Criteria:

* Written informed consent.
* Male or female patients 40 years of age or older.
* Smoking history of at least 10 pack years.
* Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1\<70% of FVC and on stable respiratory medication.

Exclusion Criteria:

* Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate.
* Myocardial infarction in past 6 months.
* Unstable or life threatening arrhythmia in past year.
* Hospitalization for NYHA heart failure class III or IV in past year.
* Active tuberculosis.
* Asthma.
* Pulmonary resection.
* Malignancy treated with radiation or chemotherapy in past 5 years.
* Respiratory infection in 4 weeks prior to screening.
* Known hypersensitivity to anticholinergic drugs or components.
* Known moderate to severe renal impairment.
* Known narrow angle glaucoma.
* Significant symptomatic BPH or bladder neck obstruction.
* Need for oxygen therapy \>12 hr/day.
* Use of oral corticosteroids at unstable doses or \>10 mg/day.
C: Inclusion Criteria:

* Established diagnosis of COPD by medical doctor (based on clinical history OR pulmonary function test)
* Smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, etc.)
* Current hospitalization for potential infectious AECOPD treated with standard therapy
* History of at least one exacerbation during the last year (prior to the current hospital admission) for which systemic steroids and/or antibiotics were taken
* ECG at admission

Exclusion Criteria:

* Mechanical or non-invasive ventilation at moment of randomization (D1)
* Long QT interval on ECG (QTc \> 450msec for males or \> 470msec for females)
* History of life-threatening arrhythmias
* Myocardial infarction (NSTEMI or STEMI) less than 6 weeks before start of study drug
* Unstable angina pectoris or acute myocardial infarction (NSTEMI or STEMI) at admission
* Drugs with high risk for long QT interval and torsade de pointes (amiodarone, flecainide, procainamide, sotalol, droperidol, haldol, citalopram, other macrolides)
* Documented uncorrected severe hypokalemia (K+ \< 3.0 mmol/L) or hypomagnesemia (Mg2+ \< 0.5 mmol/L)
* Chronic systemic steroids (\> 4 mg methylprednisolone /day for ≥ 2 months)
* Actual use of macrolides for at least 2 weeks
* Allergy to macrolides
* Active cancer treatment
* Life expectancy \< 3 months
* Pregnant or breast-feeding subjects. Woman of childbearing potential must have a pregnancy test performed and a negative result must be documented before start of treatment
D: Inclusion Criteria:

* Histologically confirmed stage III or IV ovarian epithelial or serous primaryperitoneal carcinoma
* The following are ineligible:

  * Germ cell tumors
  * Sex cord-stromal tumors
  * Carcinosarcomas
  * Mixed Mullerian tumors or carcinosarcomas
  * Metastatic carcinomas from other sites to theovary
  * Low malignant potential tumors, including micropapillary serouscarcinomas
  * Mucinous primary peritoneal carcinoma
* Prior ovarian low malignant potential tumor (borderline carcinoma) that was surgically resected with subsequent development of invasive adenocarcinoma allowed if no prior chemotherapy
* Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
* Prior breast cancer allowed provided the following are true:

  * Disease-free for more than 5 years
  * No prior cytotoxic chemotherapy for breast cancer
* Prior or concurrent primary endometrial cancer allowed if the following conditions are met:

  * Stage no greater than IB
  * Less than 3 mm invasion without vascular or lymphatic invasion
  * No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesions
* Performance status - GOG 0-2
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* No acute hepatitis
* Creatinine no greater than 1.5 times ULN
* No unstable angina
* No myocardial infarction within the past 6 months
* No evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block) unless stable for the past 6 months
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No greater than grade 1 sensory or motor neuropathy
* No active infection that requires antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No severe or ongoing gastrointestinal bleeding that requires blood product support
* See Disease Characteristics
* Prior chemotherapy for cancer involving the abdominal cavity or pelvis allowed provided the following are true:

  * More than 3 years since prior therapy
  * No evidence of recurrent disease
* No prior radiotherapy to any portion of the abdominal cavity or pelvis
* Prior radiotherapy for localized breast, head and neck, or skin cancer allowed provided the following are true:

  * More than 3 years since prior therapy
  * No evidence of recurrent disease
* See Disease Characteristics
* No more than 12 weeks since prior surgical resection

Answer: C