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Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease (MORPHILD)

Primary Purpose

Interstitial Lung Disease, Dyspnea, Morphine

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Morphine hydrochloride
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Lung Disease focused on measuring randomised, placebo controlled, clinical trial

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Morphine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

VAS dyspnea score

Secondary Outcome Measures

Oxygen saturation
Peripheral oxygen saturation will be measured after first dose of morphine and placebo as well as after 1 week follow up
K-bild questionnaire
questionnaire regarding interstitial lung specific life quality
GAD-7 questionnaire
VAlidatet score for anxiety and depression
6 min walk test
Leicester Score
cough related score

Full Information

First Posted
December 2, 2015
Last Updated
April 8, 2019
Sponsor
University of Aarhus
Collaborators
Skanderbog Apotek
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1. Study Identification

Unique Protocol Identification Number
NCT02622022
Brief Title
Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
Acronym
MORPHILD
Official Title
Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Skanderbog Apotek

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease, Dyspnea, Morphine
Keywords
randomised, placebo controlled, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
18 patients treated with oral linctus corresponding to 5 mg morphine hydrochloride, four times daily and as needed up to 4 times daily
Intervention Type
Drug
Intervention Name(s)
Morphine hydrochloride
Other Intervention Name(s)
Placebo
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
VAS dyspnea score
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
Peripheral oxygen saturation will be measured after first dose of morphine and placebo as well as after 1 week follow up
Time Frame
1 hour and 1 week
Title
K-bild questionnaire
Description
questionnaire regarding interstitial lung specific life quality
Time Frame
1 week
Title
GAD-7 questionnaire
Description
VAlidatet score for anxiety and depression
Time Frame
1 week
Title
6 min walk test
Time Frame
1 hour and 1 week
Title
Leicester Score
Description
cough related score
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32703194
Citation
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.
Results Reference
derived

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Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

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