UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Title of the study (Brief title)	Intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Region	Japan

Condition
Condition	Chronic obstructive pulmonary disease accompanied by pneumothorax
Classification by specialty	Chest surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is a single institute phase II study to investigate the effects of intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Spirometry Blood gas examination Hugh-Jones score Performance statis Hospital stay Recurrence free survival Overall survival CT value of lung
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Sustained-release basic fibroblast growth factor (2.5 mg) diluted with fibrin glue solution is administrated to patients with chronic obstructive pulmonary disease accompanied by pneumothorax through chest drainage tube.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Key exclusion criteria	Patients with malignant tumors Patients with intrapleural bacterial infection Patients with allergy for gelatin Patients with past history of side effect by trafermin
Target sample size	30

Research contact person
Name of lead principal investigator	Tatsuya Yoshimasu
Organization	Wakayama Medical University
Division name	Department of Thoracic and Cardiovascular Surgery
Address	811-1 Kimiidera, Wakayama, 641-8509, Japan
TEL
Email

Public contact
Name of contact person	Tatsuya Yoshimasu
Organization	Wakayama Medical University
Division name	Department of Thoracic and Cardiovascular Surgery
Address	811-1 Kimiidera, Wakayama, 641-8509, Japan
TEL	073-447-2300
Homepage URL
Email	yositatu@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Wakayama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Institute for Frontier Medical Sciences, Kyoto University
Name of secondary funｄer(s)

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	和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 06 Month 30 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2018 Year 04 Month 30 Day
Date of closure to data entry	2018 Year 05 Month 31 Day
Date trial data considered complete	2018 Year 05 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Finished.
Other related information

Management information
Registered date	2010 Year 09 Month 28 Day
Last modified on	2018 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005129