UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Retrospective Study of Prognostic Factors in Patients with Interstitial Pneumonia Receiving Long-Term Oxygen Therapy
Title of the study (Brief title)	Prognosis of IP Patients Receiving LTOT
Region	Japan

Condition
Condition	Interstitial pneumonia
Classification by specialty	Medicine in general Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We retrospectively analyzed 76 patients (49 with idiopathic interstitial pneumonia and 27 with interstitial pneumonia associated with collagen vascular disease) with clinically diagnosed interstitial pneumonia who received LTOT to investigate the prognosis from the initiation of LTOT and clarify prognostic factors.
Basic objectives2	Others
Basic objectives -Others	Retrospective obserbational study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival time from the initiation of long-term-oxygen therapy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 clinically diagnosed idioathic interstitial pneumonia or interstitial pneumonia associated with collagen vascular disease who initiated to receive long-term oxygen therapy in Osaka University Hospital from January 1999 to December 2012 were searched. The diagnosis of interstitial pneumonia was determined based on laboratory data, pulmonary function test, physical examination, and high resolution computed tomography findings. The diagnosis of collagen vascular disease was according to established guideline. Long-term oxygen therapy was initiated if PaO2 of arterial blood gas at rest under room air was below 60 mmHg; or if SpO2 on exertion breathing room air was below 90 accompanied by significant dyspnea.
Key exclusion criteria	Exclusion criteria were as follows: subjects with interstitial pneumonia suspected to be secondary to environmental exposure or drug toxicities; subjects with severe organ disease or active invasive cancer at the initiation of long-term oxygen therapy.
Target sample size	80

Research contact person
Name of lead principal investigator	Takashi Kijima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Address	2-2 Yamadaoka Suita, Osaka 565-0871, Japan
TEL	06-6879-3833
Email	tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Masayoshi Higashiguchi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Address	2-2 Yamadaoka Suita, Osaka 565-0871, Japan
TEL	06-6879-3833
Homepage URL
Email	higashiguchim@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Department of Respiratory Medicine, Allergy, and Rheumatic Diseases Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Respiratory Medicine, Allergy, and Rheumatic Diseases Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 16 Day
Anticipated trial start date	2013 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Serching suitable cases

Management information
Registered date	2013 Year 12 Month 16 Day
Last modified on	2017 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014730