Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

Phase 4

Completed

• Conditions: Interstitial Lung Disease; Dyspnea; Morphine
• Interventions: Drug: Morphine hydrochloride; Other: Placebo

• Registration Number: NCT02622022
• Lead Sponsor: University of Aarhus

Brief Summary

36 patients with interstitial lung disease will be randomized to 1 weeks treatment with morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4 times a day, or corresponding doses of placebo.

VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-02
• Study First Posted: 2015-12-04
• Study Start: 2016-01
• Primary Completion: 2019-02-06
• Study Completion: 2019-02-06
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestous, drug induced ILD, unclassified ILD)
• Dyspnea corresponding to Medial Research Councils (MRC) dyspnea score ≥ 3
• Written consent
• Age ≥ 18 years
• Competent
• For fertile women: Negative pregnancy test
• For fertile and sexually active participants: Use of safe anti-conceptionals

Read More

Exclusion Criteria

• Ongoing infection
• Decreased lung function to a degree which makes any form of respiratory depression life threatening
• Treatment with morphine or morphine analogues
• Allergy towards morphine hydrochloride

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine hydrochloride	18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily
Placebo	Placebo	18 patients treated with oral linctus corresponding to 5 mg morphine hydrochloride, four times daily and as needed up to 4 times daily

Primary Outcome Measures

Name	Time	Method
VAS dyspnea score	1 week

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	1 hour and 1 week	Peripheral oxygen saturation will be measured after first dose of morphine and placebo as well as after 1 week follow up
K-bild questionnaire	1 week	questionnaire regarding interstitial lung specific life quality
GAD-7 questionnaire	1 week	VAlidatet score for anxiety and depression
6 min walk test	1 hour and 1 week
Leicester Score	1 week	cough related score

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus C, Denmark