Palliation of Dyspnea and Cough using Morphine in patients with Fibrotic Interstitial Lung Disease

Phase 1

Conditions: Fibrotic Interstitial Lung Disease
MedDRA version: 21.1Level: PTClassification code: 10022611Term: Interstitial lung disease Class: 100000004855
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: CTIS2023-503700-81-00

Lead Sponsor: Aarhus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main object of the study is to examine the effect of 4 weeks treatment with slow-release morphine compared to placebo on the perception of breathlessness in patients with fibrotic interstitial lung diseases.;Secondary Objective: To examine the effect of 4 weeks treatment with slow-release morphine on the perception of cough, physical exertion and quality of life in patients with fibrotic interstitial lung diseases.;Primary end point(s): The change in average VAS score for dyspnea the last 24-hours (baseline) measured over a week and after 4 weeks treatment with morphine.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change in level of desaturation at 6-minute walk test from baseline to follow-up after 4 weeks of treatment;Secondary end point(s):Change in BORG dyspnea scale at 6-minute walk test from baseline to follow-up after 4 weeks of treatment;Secondary end point(s):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;Secondary end point(s):Change in walking distance during 6-minute walk test from baseline to follow-up after 4 weeks of treatment