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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026114
Receipt No. R000014363
Scientific Title A Retrospective Study of Prognostic Factors in Patients with Interstitial Pneumonia Receiving Long-Term Oxygen Therapy
Date of disclosure of the study information 2017/02/13
Last modified on 2017/02/13

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Basic information
Public title A Retrospective Study of Prognostic Factors in Patients with Interstitial Pneumonia Receiving Long-Term Oxygen Therapy
Acronym Prognosis of IP Patients Receiving LTOT
Scientific Title A Retrospective Study of Prognostic Factors in Patients with Interstitial Pneumonia Receiving Long-Term Oxygen Therapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Zip code
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
1st name
Middle name
Last name Takashi Kijima
Organization Osaka University Graduate School of Medicine
Division name Department of Respiratory Medicine, Allergy, and Rheumatic Diseases
Zip code
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)

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
2017 Year 02 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007/s00408-014-9623-4
Number of participants that the trial has enrolled
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.
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
2013 Year 10 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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