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Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease

Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease - Phase I study of safety of morphine for dyspnea in patients with interstitial lung disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016137
Enrollment
12
Registered
2015-01-06
Start date
2015-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea in patients with interstitial lung disease

Interventions

Single subcutaneous injection of morphine 1mg or 2mg.

Sponsors

Non-Profit Organization JORTC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Inpatients with interstitial lung diseases diagnosed by more than 1 radiologist and more than 2 respiratory physicians based on clinical course, chest CT, lung function test and so on. 2. Patients with severe dyspnea at rest after standard treatment for dypnea 3. Patients who have the following data at baseline: AST <= 100 IU/L ALT <= 100 IU/L T-BIL <= 2.0 mg/dL SPO2 >= 90 % (Oxygen is allowed) PaCO2 <= 50 Torr (Oxygen is allowed) 4. Patients aged 20 years-old or older at the time of obtaining informed consent 5. Patients with expected survival of 1 month or longer 6. Patients with lucidity and capability of communication and without cognitive inpairments 7. Patients who agree to participate the study with written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with contraindication of morphine (ex. allergy for morphine and history of severe adverse effects of morphine) 2. Patients who use opioid 3. Patients with left heart failure by echocardiography. 4. Patients with acute respiratory failure ( bacterial pneumonia, acute excerbation of interstitial pneumonia and so on). 5. Patients with active infection that causes dyspnea 6. Patients with lung cancer that causes dyspnea 7. Patients with pneumothorax 8. Patients who uses invasive positive airway pressure ventilation. Patients who uses nasal high flow were not excluded 9. Patients who changed the way of intaking of corticosteroids, immunosuppressant, bronchodilators, vasodilators and anxiolytics within two days before enrollment of the study 10. Patients who have or had drug abuse or drug dependence 11. Patients who are pregnant or possibly pregnant 12. Patients who are judged to be innapropriate for the study by the physician

Design outcomes

Primary

MeasureTime frame
Respiratory depression and hypotension defined in the protocol and adverse effect >= Grade 3 (CTCAE)

Secondary

MeasureTime frame
1. Dyspnea NRS change between before and after morphine treatment 2. Heart rate before and after treatment 3. PaO2 and PaCO2 before and after treatment. 4. Number of vomitting 5. Derilium 6. Sedation 7. Adverse effect between 60 minutes and 24 hours after treatment.

Countries

Japan

Contacts

Public ContactYoshinobu Matsuda

National Hospital Organization Kinki-Chuo Chest Medical Center Department of Psychosomatic Internal Medicine

ymatsuda@kch.hosp.go.jp072-252-3021

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026