We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02622022
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
Skanderbog Apotek
Information provided by (Responsible Party):
Charlotte Andersen, University of Aarhus

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)


Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Dyspnea Morphine Drug: Morphine hydrochloride Other: Placebo Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
Study Start Date : January 2016
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Drug: Morphine hydrochloride
Other Name: Placebo
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
 Other: Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. VAS dyspnea score [ Time Frame: 1 week ]

Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622022


Locations
Layout table for location information
Denmark
Aarhus University Hospital
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Skanderbog Apotek
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Charlotte Andersen, MD, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT02622022    
Other Study ID Numbers: 2015-002533-22
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Charlotte Andersen, University of Aarhus:
randomised
placebo controlled
clinical trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Dyspnea
Lung Diseases, Interstitial
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Morphine
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents