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

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

Matsuda Yoshinobu

National Hospital Organization Kinki-Chuo Chest Medical Center

Nagasone-Cho 1180, Kita-Ku, Sakai City, Osaka

matsuda.yoshinobu.tx@mail.hosp.go.jp

Matsuda Yoshinobu

National Hospital Organization Kinki-Chuo Chest Medical Center

Nagasone-cho 1180, Kita-ku, Sakai city, Osaka

+81-72-252-3021

matsuda.yoshinobu.tx@mail.hosp.go.jp

Recruiting

June. 27, 2019

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

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

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

Both

Interstitial lung disease

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

Interstitial lung disease

morphine

Lung Diseases, Interstitial

morphine

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

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

+81-6-6645-3456

Mar. 22, 2019

Yes

Immediately after the publication of the primary results, de-identified individual participant data that underlie the results reported in the article(s) and other documents (study protocol and statistical analysis plan) will be available for any purpose, only if approved by JORTC Independent Data Monitoring Committee (IDMC). Anyone who wishes to access the data should submit a proposal to office@idmc.jortc.jp. If approved, data requestors will need to sign a data access agreement. After that, JORTC Data Center will transfer the data and other documents to data requestors.

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