Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-02-06

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)

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Detailed Description

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Conditions

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Interstitial Lung Disease Dyspnea Morphine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Morphine

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

Group Type ACTIVE_COMPARATOR

Morphine hydrochloride

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Morphine hydrochloride

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Placebo

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No