Skip to main content
Clinical Trials/NCT02622022
NCT02622022
Completed
Phase 4

Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

University of Aarhus1 site in 1 country36 target enrollmentJanuary 2016

Overview

Phase
Phase 4
Intervention
Morphine hydrochloride
Conditions
Interstitial Lung Disease
Sponsor
University of Aarhus
Enrollment
36
Locations
1
Primary Endpoint
VAS dyspnea score
Status
Completed
Last Updated
7 years ago

Overview

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)

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
February 6, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charlotte Andersen

MD, PhD

University of Aarhus

Eligibility Criteria

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

Arms & Interventions

Morphine

18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily

Intervention: Morphine hydrochloride

Placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

VAS dyspnea score

Time Frame: 1 week

Secondary Outcomes

  • Oxygen saturation(1 hour and 1 week)
  • K-bild questionnaire(1 week)
  • GAD-7 questionnaire(1 week)
  • 6 min walk test(1 hour and 1 week)
  • Leicester Score(1 week)

Study Sites (1)

Loading locations...

Similar Trials