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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