Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 6, 2019

Interventions

  • Drug: Morphine hydrochloride
  • Other: Placebo

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • VAS dyspnea score
    • Time Frame: 1 week

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 110 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Collaborator
    • Skanderbog Apotek
  • Provider of Information About this Clinical Study
    • Principal Investigator: Charlotte Andersen, MD, PhD – University of Aarhus

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