Randomized, placebo-controlled phase II study of efficacy of morphine for dyspnea in patients with interstitial lung disease: JORTC-PAL15

JRCT ID: jRCTs051190030

Registered date:27/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Interstitial lung disease
• Date of first enrollment: 05/09/2019
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Morphine arm: single subcutaneous morphine 2 mg
Placebo arm: single subcutaneous saline 2mL

Outcome(s)

• Primary Outcome: Difference of change of dyspnea at rest in NRS from baseline to 60 minutes after morphine injection between morphine arm and placebo arm

Secondary Outcome

1.Change of dyspnea at rest in NRS from baseline to 30 minutes after morphine or placebo injection
2.Difference of rates of patients whose dyspnea NRS decreased more than 1 between two arms
3.Respiratory rate
4.Blood pressure
5.SpO2
6.Pulse rate
7.Vomiting frequency (events/day)
8.Sedation (Richmond Agitation and Sedation Scale)
9.Other adverse events between baseline and 24 hours after injection of morphine or saline

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients who are diagnosed with ILD by two respiratory physicians and one respiratory radiologist
2.Patients who have dyspnea at restdespite conventional treatment, with NRS 3 or more
3.Patients who have normal liver and renal function ( AST 100 IU/L or less, ALT 100 IU/L or less, T-Bil 2.0 mg/dL or less, sCre 2.0 mg/dL or less), blood oxygen saturation levels (SpO2) 90% or more and partial pressure of carbon dioxide (PaCO2) 60 Torr or less (Supplemental oxygen was allowed)
4.Adult patients (20 years old or older)
5.Patients who has expected survival of 1 month or longer
6.Patients who is capable of communication and did not have cognitive impairments
7.Patients who provided written informed consents

Exclude criteria

1.Patients who have contraindication for morphine
2.Patients who use opioids
3.Patients who have left heart failure (EF < 50%) confirmed by echocardiography
4.Patients who have acute respiratory failure
5.Patients who have infection that causes dyspnea
6.Patients who have lung cancer that causes dyspnea
7.Patients who have bronchial asthma attack
8.Patients who have pneumothorax requiring thoracic drainage
9.Patients who use mechanical ventilation
10.Patients who have current or past history of drug abuse
11.Patients who are pregnant

Related Information

• Primary Sponsor: Matsuda Yoshinobu
• Source(s) of Monetary Support: Grants-in-aid for Young Scientists (A),The Osaka Medical Research Foundation for Intractable Diseases.