Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

Study Overview
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Brief Summary
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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)

Official Title
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Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

Conditions
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Interstitial Lung Disease, Dyspnea, Morphine

Intervention / Treatment
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* Drug: Morphine hydrochloride
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine<br>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<br> <br> * Other names: Placebo;|
| Placebo Comparator: Placebo<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS dyspnea score |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| K-bild questionnaire | questionnaire regarding interstitial lung specific life quality | 1 week | 
| GAD-7 questionnaire | VAlidatet score for anxiety and depression | 1 week | 
| 6 min walk test |  | 1 hour and 1 week | 
| Leicester Score | cough related score | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomised, placebo controlled, clinical trial