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Table 2 Main inclusion and exclusion criteria

From: Implementing lessons learned from previous bronchial biopsy trials in a new randomized controlled COPD biopsy trial with roflumilast

Main inclusion criteria Main exclusion criteria
Written informed consent obtained according to local regulations Clinical instability (exacerbation 6 months prior to baseline as indicated by treatment)
History of COPD for at least 12 months prior to baseline, with chronic productive cough for at least three months in each of the two years prior to baseline Upper/lower respiratory tract infection not resolved 4 weeks prior to baseline
Outpatients 40–80 years of age Diagnosis of asthma and/or other relevant lung disease or previous episodes of pneumothorax
Post-bronchodilator 30%  ≤ FEV1 ≤ 80% predicted Known alpha-1 antitrypsin deficiency
Post-bronchodilator FEV1/FVC ratio ≤ 70% History of intubation for COPD or a respiratory failure of any cause in the past year
Current or former smokers with smoking history ≥ 20 pack years Formal contraindications to sputum collection
  Suspicion or diagnosis of a bleeding disorder irrespective of its pathophysiological mechanism