Morphine for dysnea in patients with lung fibrosis

Phase 1

• Conditions: Interstitial Lung disease; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-002533-22-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-12
• Study Completion: 2019-02-06
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

•A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestosis, drug induced ILD, un classified ILD)
•Dyspnea Medial Research Councils (MRC) dyspnea score = 3
•Informed written consent
•Age = 18 years
•Habile
•For fertile women: negative HCG before inclusion
•For fertile and sexualle active persons: Secure birth control during the study period and the day after
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

•Treatment with morpine or morphne analogues
•Allergy towards morphine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if morphine hydrochloride administered for 7 days is safe and attenuates dyspnea in patients with interstitial lung disease and dyspnea;Secondary Objective: To investigate if the abovementioned treatment reduces anxiety and improvesexercise capacity;Primary end point(s): Change in VAS dyspnea score after 7 days treatment with oral morhine drops;Timepoint(s) of evaluation of this end point: at baseline and after 7 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Frequency of breathing<br>Blood pressure and pulse<br>Arterial oxygen and CO2 content<br>6 min walk test distance, peripheral saturation and Borgs dyspnea score at the 6 min walk test<br>Cough (VAS and Leicester cough score) <br>ILD specific life quality (KBILD) <br>depression and anxiety score (GAD-7).<br>;Timepoint(s) of evaluation of this end point: At baseline and after 7 days