Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
MORPHILD
1 other identifier
interventional
36
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2015
CompletedFirst Posted
Study publicly available on registry
December 4, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2019
CompletedApril 10, 2019
April 1, 2019
3.1 years
December 2, 2015
April 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS dyspnea score
1 week
Secondary Outcomes (5)
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 Arms (2)
Morphine
ACTIVE COMPARATOR18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily
Placebo
PLACEBO COMPARATOR18 patients treated with oral linctus corresponding to 5 mg morphine hydrochloride, four times daily and as needed up to 4 times daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Skanderbog Apotekcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus C, 8000, Denmark
Related Publications (1)
Kronborg-White S, Andersen CU, Kohberg C, Hilberg O, Bendstrup E. Palliation of chronic breathlessness with morphine in patients with fibrotic interstitial lung disease - a randomised placebo-controlled trial. Respir Res. 2020 Jul 23;21(1):195. doi: 10.1186/s12931-020-01452-7.
PMID: 32703194DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
December 2, 2015
First Posted
December 4, 2015
Study Start
January 1, 2016
Primary Completion
February 6, 2019
Study Completion
February 6, 2019
Last Updated
April 10, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share