MORPHINE SULFATE for Fibrotic interstitial lung disease|Interstitial lung disease

Inclusion criteria

• {"criterion_text":"- fibrotic interstitial lung disease"}
• {"criterion_text":"- GAP (Gneder-Age-Physiology) score 2-3"}
• {"criterion_text":"- Presence of fibroses on HRCT (tractionbronchiectasis, honeycombing, loss of volume >10% assessed by the investigator"}
• {"criterion_text":"- MRC (Medical Research Councils) dyspnea score ≥ 3"}
• {"criterion_text":"- Informed written consent"}
• {"criterion_text":"- Age ≥ 18 år"}
• {"criterion_text":"- Authoritative"}

Exclusion criteria

• {"criterion_text":"- Regular treatment with morphine or morphine analogues"}
• {"criterion_text":"- Allergy or intolerance to morphine or morphine analogues"}
• {"criterion_text":"- Ongoing infection or exacerbation"}
• {"criterion_text":"- Patients with so severe impaired respiration that any form of worsening would be too risky (assessed by the investigator)"}
• {"criterion_text":"- Treatment with benzodiazepines (not benzodiazepine receptor agonists)"}

Primary endpoints

• {"endpoint_text":"- The change in average VAS score for dyspnea the last 24-hours (baseline) measured over a week and after 4 weeks treatment with morphine.","definition_or_measurement_approach":"Change in average Visual Analogue Scale (VAS) score for dyspnea over the last 24 hours (baseline) measured over a week and after 4 weeks of treatment."}

Secondary endpoints

• {"endpoint_text":"- Change in walking distance during 6-minute walk test from baseline to follow-up after 4 weeks of treatment","definition_or_measurement_approach":"Change in distance (meters) walked during a 6-minute walk test from baseline to 4-week follow-up."}
• {"endpoint_text":"- Change in level of desaturation at 6-minute walk test from baseline to follow-up after 4 weeks of treatment","definition_or_measurement_approach":"Change in oxygen desaturation measured during the 6-minute walk test from baseline to 4-week follow-up."}
• {"endpoint_text":"- Change in BORG dyspnea scale at 6-minute walk test from baseline to follow-up after 4 weeks of treatment","definition_or_measurement_approach":"Change in BORG dyspnea scale score recorded during the 6-minute walk test from baseline to 4-week follow-up."}
• {"endpoint_text":"- Change in questionnaire (VAS for tough, Leicester Cough Questionnaire, King's Brief Lung Disease Questionnaire, COPD assessment Score) from baseline to follow-up after 4 weeks of treatment","definition_or_measurement_approach":"Change in patient-reported outcomes assessed by VAS for cough, Leicester Cough Questionnaire, King's Brief Interstitial Lung Disease Questionnaire (K-BILD), and COPD Assessment Test from baseline to 4-week follow-up."}

Denmark

Earliest CTIS Part Ii Submission Date

27-02-2024

Latest Decision Or Authorization Date

11-03-2024

Processing Time Days

13

Number Of Sites

3

Number Of Participants

110

Primary sponsor

Full Name

Aarhus University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties codes: 1;9","organisation_type":"Educational Institution"}