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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007829
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009207

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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