interstitial pneumonia
Conditions
Interventions
Morphine sulfate hydrate extended-release fine granules, 5 mg twice daily for 3 days, then 10 mg twice daily every 12 hours for 6 to 7 days.
Sponsors
Suda Takafumi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who are 20 years old or older at the time of consent 2. Patients with a diagnosis of interstitial pneumonia 3. Patients with dyspnea (mMRC >= 3) despite standard therapy for the primary disease 4. All of the following laboratory values within 28 days prior to enrollment AST == 90% (oxygen can be administered) 5. Patients with a prognosis of more than 1 month 6. Patients who can answer and fill in the questionnaire by themselves 7. Patients whose written consent has been obtained from the patient
Exclusion criteria
Exclusion criteria: 1. Patients with severe respiratory depression 2. Patients with bronchial asthma attacks 3. Patients with severe hepatic impairment 4. Patients with physical findings suggestive of cardiac failure secondary to chronic pulmonary disease 5. Patients in a convulsive state 6. Patients with acute alcohol intoxication 7. Patients with hypersensitivity to opium alkaloids 8. Patients with hemorrhagic colitis 9. Patients receiving nalmefene hydrochloride hydrate or within 1 week of discontinuation of nalmefene hydrochloride hydrate 10. Patients with bacterial diarrhea 11. Patients with PaCO2 >= 60 Torr 12. Patients with symptoms of acute respiratory failure (e.g., bacterial pneumonia, acute exacerbation of interstitial pneumonia) within 1 months prior to enrollment 13. Patients with active infection-causing dyspnea 14. Patients with lung cancer complications causing dyspnea 15. Patients with complications of pulmonary thromboembolism 16. Patients on a ventilator 17. Patients on opioid preparations (except codeine phosphate hydrate less than 60 mg/day) 18. Patients with drug abuse, dependence, or a history of drug abuse or dependence 19. Pregnant women, lactating women, or patients who may be pregnant 20. Other patients deemed ineligible by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment completion rate (tolerability) over the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events (evaluation of the safety of morphine extended-release products) 2. Evaluation of dyspnea: mMRC questionnaire, NRS (Numerical Rating Scale) Worst (worst value within 24 hours), Average (average value over 24 hours) 3. Quality of life assessment related to interstitial pneumonia: CAT (COPD assessment test), K-BILD (King's Brief Interstitial Lung Disease Questionnaire) 4. Other assessment indices: ESAS-r-J ESAS-r-J (Edmonton Symptom Assessment System Revised Japanese version: Evaluation of overall physical condition) HADS (Hospital Anxiety Depression Scale: Assessment of depression) ECOG PS (Evaluation of performance status) EQ5D-5L (Evaluation of overall quality of life) 5. 4m walking speed (exertional load method) | — |
Contacts
Public ContactHideki Yasui
Hamamatsu University Hospital
Outcome results
None listed