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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02622022
Other study ID # 2015-002533-22
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2016
Est. completion date February 6, 2019

Study information

Verified date April 2019
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Morphine hydrochloride

Other:
Placebo


Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus C

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Skanderbog Apotek

Country where clinical trial is conducted

Denmark, 

Outcome

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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