UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007829 |
|---|---|
| Receipt number | R000009207 |
| Scientific Title | Fractional exhaled nitric oxide (FeNO) in airway involvement by relapsing polychondritis (RP) |
| Date of disclosure of the study information | 2012/04/24 |
| Last modified on | 2014/06/01 14:03:51 |
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Basic information
Public title
Fractional exhaled nitric oxide (FeNO) in airway involvement by relapsing polychondritis (RP)
Acronym
FeNO in RP
Scientific Title
Fractional exhaled nitric oxide (FeNO) in airway involvement by relapsing polychondritis (RP)
Scientific Title:Acronym
FeNO in RP
Region
| Japan |
Condition
Condition
patients with relapsing polychondritis
patients with bronchial asthma
healthy volunteers
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To comfirm the efficacy of fractional exhaled nitric oxide (FeNO) in airway involvement by relapsing polychondritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare FeNO between patients with relapsing polychondritis and healthy volunteers, and patients with relapsing polychondritis and bronchial asthma
Key secondary outcomes
1. Correlation between FeNO2 and subject complaints (mMRC, Borg scale and VAS)
2. Correlation between FeNO and pulmonary function tests (spirometry and IOS)
3. Correlation between FeNO and eosinophil in sputum
4. Correlation between FeNO and CRP, ESR and MMP-3
5. Variation coefficient of FeNO
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients with relapsing polychodiritis
Interventions/Control_2
Healthy volunteers
Interventions/Control_3
Patients with bronchial asthma
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
Patients with relapsing chondritis
Healthy volunteers
Patients with bronchial asthma
Key exclusion criteria
1) Refused informed consent
2) Exacerbation within the last 3 months for bronchial asthma
3) Patients who are pregnant, possibly pregnant, or lactating.
4) Patients with renal failure. (serum creatinine > 2.0 mg/dL, BUN > 30mg/dl)
5) AST or ALT > 100IU
6) Patients with severe diabetes, hyperlipidemia or hyperuricemia
7) Patients who are judged inappropriate by the investigator in charge.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruomi Miyazawa |
Organization
St. Marianna University School of Medicine
Division name
Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Handa |
Organization
St. Marianna University School of Medicine
Division name
Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 24 | Day |
Last modified on
| 2014 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009207
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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