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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