UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005098 |
|---|---|
| Receipt number | R000006057 |
| Scientific Title | A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia |
| Date of disclosure of the study information | 2011/02/18 |
| Last modified on | 2014/12/18 12:29:44 |
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Basic information
Public title
A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia
Acronym
ambulatory oxygen in patients with IPF and desaturation but without resting hypoxemia
Scientific Title
A randomized trial of ambulatory oxygen in patients with idiopathic pulmonary fibrosis and desaturation but without resting hypoxemia
Scientific Title:Acronym
ambulatory oxygen in patients with IPF and desaturation but without resting hypoxemia
Region
| Japan |
Condition
Condition
idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the short-term effect of ambulatory oxygen in patients with IPF and desaturation but without resting hypoxemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
dyspnea after 6-min walk
Key secondary outcomes
O2 saturation after 6-min walk
6-min walk distance
fatigue after 6-min walk
heart rate after 6-min walk
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
ambulatory oxygen
Interventions/Control_2
ambulatory air
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) patients with idiopathic pulmonary fibrosis diagnosed with ATS/ERS/JRS guideline 2011
2) resting PaO2 >=60mmHg and < 80mmHg
3) desaturation (SpO2 <88%) on 6-min walk
4) without any infection and acute exacerbation within preceding 3 mo
5) written informed consent
Key exclusion criteria
1) patients with uncontrolled comorbidities
2) patients who cannot undergo pulmonary function test and/or 6-min walk test
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Nishiyama |
Organization
Kinki University School of Medicine
Division name
Department of Respiratory Medicine and Allergology
Zip code
Address
377-2 Onohigashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
nishi-o@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Nishiyama |
Organization
Kinki University School of Medicine
Division name
Department of Respiratory Medicine and Allergology
Zip code
Address
377-2 Onohigashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
nishi-o@med.kindai.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Allergology, Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
近畿大学医学部（大阪府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23806287
Number of participants that the trial has enrolled
Results
RESULTS: Twenty patients (16 men), with a mean age of 73.5 (SD 4.1) years, % predicted forced vital capacity (FVC) of 71.0 (13.3) %, % predicted diffusion capacity for carbon monoxide (DLco) of 57.0 (13.3) %, and PaO2 of 72.5 (5.4) mm Hg were recruited. No significant differences in dyspnea were observed between ambulatory oxygen and air at each time point. However, some patients showed improvement in dyspnea with oxygen on an individual basis.
CONCLUSIONS: Since oxygen provides no additional benefit over air in terms of exertional dyspnea for IPF patients without resting hypoxemia, routine prescription of ambulatory oxygen is not recommended. However, assessment on an individual basis is necessary.
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
| 2010 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 16 | Day |
Last modified on
| 2014 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006057
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
