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
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We retrospectively analyzed 76 patients who were clinically diagnosed with interstitial pneumonia and initiated to be prescribed long-term oxygen therapy to investigate the prognosis from the initiation of long-term oxygen therapy and clarify prognostic factors.
Basic objectives2	Others
Basic objectives -Others	Epidemiological survey
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 who were clinically diagnosed as idiopathic interstitial pneumonia or interstitial pneumonia associated with collagen vascular disease and initiated to be prescribed 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.
Key exclusion criteria	subjects with intersititl apneumonia 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, Japan
TEL	06-6879-3833
Email	tkijima@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	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, Japan
TEL	06-6879-3833
Homepage URL
Email	tkijima@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	None
Organization
Division
Category of Funding Organization	Other
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	2017 Year 02 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 30 Day
Anticipated trial start date	2013 Year 11 Month 30 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	Published
URL releasing results	http://link.springer.com/article/10.1007/s00408-014-9623-4
Results	PURPOSE: We retrospectively analyzed patients with clinically diagnosed interstitial pneumonia to investigate the factors which contribute to the difference in prognosis from the initiation of long-term oxygen therapy (LTOT) among subtypes. METHODS: Seventy-six patients with clinically diagnosed idiopathic interstitial pneumonia (IIP; n = 49) or interstitial pneumonia associated with collagen vascular disease (CVD-IP; n = 27) in whom LTOT was initiated in our facility from January 1999 to December 2012 were analyzed. RESULTS: Patients with CVD-IP had significantly longer survival time from the initiation of LTOT than those with IIP with the median survival of 51.7 months versus 18.8 months, respectively. The 1-year survival rate was 92.4% for patients with CVD-IP versus 76.5% for those with IIP, and 2-year survival was 88.6 versus 36.0%, respectively. The patterns classified with high-resolution computed tomography (HRCT) were not associated with prognosis. The association between pulmonary hypertension and prognosis was unclear. In results of the multivariate Cox analysis which included factors demonstrating p < 0.1 in the univariate Cox analysis, male gender, low body mass index, and the absence of collagen vascular disease (CVD) were significantly associated with poor prognosis. CONCLUSIONS: After the initiation of LTOT, patients with IIP had poor prognosis regardless of the patterns classified with HRCT, while those with CVD-IP survived longer. Male gender, low body mass index, and the absence of CVD were the independent negative prognostic factors in patients with interstitial pneumonia receiving LTOT.
Other related information	Completed

Management information
Registered date	2017 Year 02 Month 13 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014363