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Table 2 In- and exclusion criteria

From: Opioids in patients with COPD and refractory dyspnea: literature review and design of a multicenter double blind study of low dosed morphine and fentanyl (MoreFoRCOPD)

Inclusion criteria
Age ≥ 40 years
Read, understood and signed the Informed Consent form
COPD GOLD class III or IV, according to GOLD criteria
 Post-bronchodilatation FEV1/FVC ≤ 70% and FEV1 < 50% pred.*
Complaints of refractory dyspnea as established by patient and doctor
mMRC score ≥ 3
Life expectancy of ≥ 2 months
Optimized standard therapy according to Dutch LAN guideline for diagnosis and treatment of COPD
Exclusion criteria
Other severe disease with chronic pain or chronic dyspnea (a non-susbstantial component of left sided heart failure is acceptable)
Current use of opioids for whatever indication
Allergy/intolerance for opioids
Psychiatric disease, not related to severe COPD
Exacerbation of COPD 8 weeks prior to inclusion or between screening and randomization
Problematic (leading to medical help or social problems) substance abuse during the last 5 years
Active malignancy, with the exception of planocellular or basal cell carcinoma of the skin
eGFR < 15 ml/min*
  1. *Measured within 6 months of screening
  2. COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, GOLD global initiative for chronic obstructive lung disease, LAN Lung Alliance The Netherlands, mMRC modified Medical Research Council Dyspnea Scale, eGFR estimated Glomerular Filtration Rate