Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease (MORPHILD)

April 8, 2019 updated by: Charlotte Andersen, University of Aarhus

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Morphine
18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily
Drug: Morphine hydrochloride
Other Names:
  • Placebo
Placebo Comparator: Placebo
18 patients treated with oral linctus corresponding to 5 mg morphine hydrochloride, four times daily and as needed up to 4 times daily
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS dyspnea score
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: 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
1 hour and 1 week
K-bild questionnaire
Time Frame: 1 week
questionnaire regarding interstitial lung specific life quality
1 week
GAD-7 questionnaire
Time Frame: 1 week
VAlidatet score for anxiety and depression
1 week
6 min walk test
Time Frame: 1 hour and 1 week
1 hour and 1 week
Leicester Score
Time Frame: 1 week
cough related score
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Skanderbog Apotek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

February 6, 2019

Study Completion (Actual)

February 6, 2019

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-002533-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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