Abstract
BackgroundPatients suffering from fibrotic interstitial lung diseases (fILD) have a poor prognosis and a high symptom burden. Palliative treatment includes relief of symptoms such as breathlessness. There is no evidence-based treatment for chronic breathlessness but opioids are often used despite concerns due to the hypothetical risk of respiratory depression. This study investigated the effect of oral morphine drops in patients with fILD on chronic breathlessness and safety.MethodsIn a double-blinded placebo-controlled study, 36 patients with fILD were randomised to either four daily doses of 5 mg of oral morphine drops or placebo for 1 week. Endpoints and safety parameters were obtained at baseline, at follow-up after 1 h and 1 week.ResultsThe primary endpoint, the visual analogue score (VAS) of dyspnea was reduced by 1.1 ± 0.33 cm in the morphine group at follow-up compared to baseline (P < 0.01), whereas the reduction was 0.35 ± 0.47 cm in the placebo group. However, the difference between the two groups was not statistically significant (p = 0.2). Oral morphine drops did not affect respiratory frequency, pulse rate, blood pressure, peripheral saturation or the 6-min walk test. More patients treated with morphine reported constipation, nausea and confusion.ConclusionOral administration of morphine drops, 20 mg a day, in patients with fILD did not significantly reduce dyspnea VAS score during 1 week compared to placebo. Oral morphine did not induce respiratory depression, but was related to an increased risk of constipation, nausea and confusion.Trial registrationThe trial is registered in clinicaltrials.gov (Identifier: NCT02622022). Registered 4 December 2015.
Highlights
Patients suffering from fibrotic interstitial lung diseases have a poor prognosis and a high symptom burden
There were no significant differences in baseline parameters diffusion capacity (DLCO) in % of expected tended to be lower in the placebo group
The main findings were that 5 mg morphine, four times a day was not effective in reducing dyspnea measured on a visual analogue score (VAS) scale
Summary
Patients suffering from fibrotic interstitial lung diseases (fILD) have a poor prognosis and a high symptom burden. Idiopathic pulmonary fibrosis (IPF) is the most frequent type and is an irreversible progressive and fatal interstitial lung disease with an average survival of three to 5 years after diagnosis. Other types of fILD including chronic hypersensitivity pneumonitis and connective tissue-related interstitial lung diseases may show a progressive phenotype with compromised survival [2]. Despite an increasing number of randomised clinical trials over the past 10–15 year, there are no curative treatments new anti-fibrotic drugs have recently been shown to slow progression and prolong survival in patients with mild to moderate IPF [3,4,5]. Due to the well-known respiratory depressant effect of opioids, treatment is often used reluctantly by health care professionals due to fear of reducing oxygenation [8]
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