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OpenTrials
Completed

NCT Number: NCT02622022

Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

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)

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Key information

Conditions

Interstitial Lung Disease Dyspnea Lung Diseases Lung Diseases, Interstitial Morphine Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine hydrochloride

Drug

Other names: Placebo

Placebo

Other

Primary outcomes

  1. VAS dyspnea score

    Time frame: 1 week

Secondary outcomes

  1. 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

  2. K-bild questionnaire

    Time frame: 1 week

    questionnaire regarding interstitial lung specific life quality

  3. GAD-7 questionnaire

    Time frame: 1 week

    VAlidatet score for anxiety and depression

  4. 6 min walk test

    Time frame: 1 hour and 1 week

  5. Leicester Score

    Time frame: 1 week

    cough related score

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Skanderbog Apotek

Registry information

Acronym: MORPHILD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2015
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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