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

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Morphine; Dyspnea; Interstitial Lung Disease

Treatments: Other: Placebo; Drug: Morphine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02622022

2015-002533-22

Details and patient eligibility

About

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)

Enrollment: 36 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Morphine

Active Comparator group

Description:

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

Treatment:

Drug: Morphine hydrochloride

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo