Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

Dyspnea Clinical Trial

— MORPHILD  

Official title:

Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622022
• Other study ID #: 2015-002533-22
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: February 6, 2019

Study information

• Verified date: April 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 6, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Dyspnea
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Morphine

Intervention

Drug:
• Morphine hydrochloride

Other:
• Placebo

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Skanderbog Apotek

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS dyspnea score		1 week
Secondary	Oxygen saturation	Peripheral oxygen saturation will be measured after first dose of morphine and placebo as well as after 1 week follow up	1 hour and 1 week
Secondary	K-bild questionnaire	questionnaire regarding interstitial lung specific life quality	1 week
Secondary	GAD-7 questionnaire	VAlidatet score for anxiety and depression	1 week
Secondary	6 min walk test		1 hour and 1 week
Secondary	Leicester Score	cough related score	1 week