UMIN-CTR Clinical Trial

Basic information
Public title	Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Acronym	Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Scientific Title	Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Scientific Title:Acronym	Before-after study of efficacy of morphine for dyspnea in patients with chronic obstructive pulmonary disease
Region	Japan

Condition
Condition	COPD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the efficacy of morphine for dyspnea in patients with COPD.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dyspnea NRS change between before (Day 0 evening) and after morphine treatment (Day 2 evening)
Key secondary outcomes	1. Dyspnea NRS change between before (Day 0 morning) and after morphine treatment (Day 1 morning, Day 2 morning) 2. Dyspnea NRS change between before (Day 0 evening) and after morphine treatment (Day1 evening). 3. Respiratory rate, blood puressure, SpO2 4. Sleep disturbance 5. Nausea NRS, Somnolence NRS, Anorexia NRS, 6. Nausea and constipation grade in CTCAE v4.0 7. Sedation 8. Derilium 9. Other adverse effect 10. Spontaneous bowel movement

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral morphine 3mg or 2mg every 6 hours (total six times)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Hospitalized patients with diagnosis of COPD based on the criteria of GOLD 2014 (FEV1/FVC<70%) 2. Patients with severe dyspnea at rest after standard treatment for dypnea 3. Patients aged 40 years-old or older at the time of obtaining informed consent 4. Patients with history of cigarette smoking of at least 10 pack-years 5. Patients who have the following data at baseline: AST <= 100 IU/L ALT <= 100 IU/L T-BIL <= 2.0 mg/dL eGFR >= 30 mL/min SPO2 >= 90 % (Oxygen is allowed) PaCO2 <= 60 Torr (Oxygen is allowed) 6. Patients who receive enough other treatment fo dyspnea of COPD 7. Patients with expected survival of 1 month or longer 8. Patients with lucidity and capability of communication and without cognitive inpairments 9. Patients who agree to participate the study with written informed consent
Key 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. Patients who did not use codein within 3 days before study entry are eligble. 3. Patients with COPD acute exacerbation 4. Patients with active infection that causes dyspnea 5. Patients with lung cancer that causes dyspnea 6. Patients with pneumothorax 7. Patients who uses invasive positive airway pressure ventilation. Patients who uses nasal high flow were not excluded 8. Patients who changed the way of intaking of bronchodilators, corticosteroids, vasodilators and anxiolytics within two days before enrollment of the study 9. Patients who have or had drug abuse or drug dependence 10. Patients who are pregnant or possibly pregnant 11. Patients who are judged to be innapropriate for the study by the physician
Target sample size	35

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yoshinobu Matsuda
Organization	National Hospital Organization Kinki-Chuo Chest Medical Center
Division name	Department of Psychosomatic Internal Medicine
Zip code
Address	1180 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8555, Japan
TEL	072-252-3021
Email	ymatsuda@kch.hosp.go.jp

Public contact
1st name of contact person	1st name Middle name Last name Yoshinobu Matsuda
Organization	National Hospital Organization Kinki-Chuo Chest Medical Center
Division name	Department of Psychosomatic Internal Medicine
Zip code
Address	1180 Nagasone-cho, Kita-ku, Sakai, Osaka, 591-8555, Japan
TEL	072-252-3021
Homepage URL
Email	ymatsuda@kch.hosp.go.jp

Sponsor
Institute	Non-Profit Organization JORTC
Institute
Department

Funding Source
Organization	National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 26 Day
Date of IRB	2014 Year 09 Month 08 Day
Anticipated trial start date	2014 Year 10 Month 09 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 09 Month 30 Day
Last modified on	2019 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017782