Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 16-week, Randomized, Placebo-controlled, Double Blind, and Parallel Group Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
Brief Summary: The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and additional in sputum and blood serum. Also data on safety status will be obtained.

Patients to be included required to have moderate to severe COPD associated with chronic bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks maximum.


Options:
A: Main Inclusion Criteria:

* COPD patients having at least one exacerbation within last year
* FEV1/FVC ratio (post-bronchodilator) ≤ 70%
* FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

* COPD exacerbation not resolved at first baseline visit
* Diagnosis of asthma and/or other relevant lung disease
B: Major Inclusion Criteria:

* Giving written informed consent
* History of COPD (according to GOLD 2009) for at least 12 months prior to baseline visit V0 associated with chronic productive cough for at least three months in each of the two years prior to baseline visit V0 (with other causes of productive cough excluded)
* Outpatients 40-80 years of age
* Post-bronchodilator 30% ≤FEV1 ≤80% predicted
* Post-bronchodilator FEV1/FVC ratio ≤70%
* Current or former smokers with smoking history ≥20 pack years

Main Exclusion Criteria:

• Criteria affecting the read-out parameters of the trial:

* Clinical instability, defined as experiencing a COPD exacerbation six months prior to V0
* An upper/lower respiratory tract infection which has not resolved four weeks prior to V0
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Suspicion or diagnosis of a bleeding disorders irrespective of its pathophysiological mechanism
* Other protocol-defined exclusion criteria may apply
C: Main Inclusion Criteria:

* FEV1/FVC ratio (post-bronchodilator) ≤70%
* FEV1 (post-bronchodilator) ≤50% of predicted
* Current smoker or ex-smoker
* Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
* Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
* Lower respiratory tract infection not resolved 4 weeks prior to baseline
* Diagnosis of asthma and/or other relevant lung disease
* Known alpha-1-antitrypsin deficiency
* Need for long-term oxygen therapy defined as ≥16 hours/day
D: Main Inclusion Criteria:

* History of COPD for at least 12 months prior to baseline visit and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
* FEV1/FVC ratio (post-bronchodilator) ≤ 70%
* FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
* Treated with tiotropium for at least 3 months before enrollment
* At least 28 puffs of rescue medication during last week prior to randomization

Main Exclusion Criteria:

* COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

Answer: B