Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-24 @ 4:48 PM
NCT ID:
NCT02429050
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of COPD according to the current Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease (GOLD);
* Optimal pharmacological treatment, including including treatment with a combination of a long-acting muscarinic antagonist and an ultra-long-acting β-agonist;
* Grade 3 or 4 dyspnea on the mMRC dyspnea scale;
* Optimal non-pharmacological treatment defined as completed a comprehensive pulmonary rehabilitation program.
Exclusion Criteria:
* History of substance misuse;
* Exacerbation of COPD within two weeks of study enrolment;
* Waiting list for lung transplantation;
* Pregnant or childbearing potential not using contraception;
* Renal failure (creatinine clearance \<15mL/min);
* Not being able to read or fill in the questionnaires or diary;
* Allergy for morphine or its excipients;
* Concomitant use of irreversible MAO blockers;
* Use of opioids;
* History of convulsions;
* Head injury;
* Intestinal obstruction;
* Gastroparesis;
* Liver disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02429050
Study Brief:
Protocol Section:
NCT02429050