Dyspnea Clinical Trial
— MORPHILDOfficial title:
Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
Verified date | April 2019 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 36 |
Est. completion date | February 6, 2019 |
Est. primary completion date | February 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus C |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Skanderbog Apotek |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS dyspnea score | 1 week | ||
Secondary | Oxygen saturation | Peripheral oxygen saturation will be measured after first dose of morphine and placebo as well as after 1 week follow up | 1 hour and 1 week | |
Secondary | K-bild questionnaire | questionnaire regarding interstitial lung specific life quality | 1 week | |
Secondary | GAD-7 questionnaire | VAlidatet score for anxiety and depression | 1 week | |
Secondary | 6 min walk test | 1 hour and 1 week | ||
Secondary | Leicester Score | cough related score | 1 week |
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