UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001019 |
|---|---|
| Receipt number | R000001230 |
| Scientific Title | Significance of exhaled NO as a diagnostic marker of persistent cough |
| Date of disclosure of the study information | 2008/02/08 |
| Last modified on | 2011/02/07 08:22:05 |
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Basic information
Public title
Significance of exhaled NO as a diagnostic marker of persistent cough
Acronym
Exhaled NO and persistent cough
Scientific Title
Significance of exhaled NO as a diagnostic marker of persistent cough
Scientific Title:Acronym
Exhaled NO and persistent cough
Region
| Japan |
Condition
Condition
persistent cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether the pre-treatment exhaled NO levels can predict the responsiveness to inhaled corticosteroid in patients with persistent cough
Basic objectives2
Others
Basic objectives -Others
To determine whether exhaled NO levels can predict the responsiveness to inhaled corticosteroid in patients with persistent cough
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of patients whose VAS score of cough symptoms improve more than 50% after treatment with inhaled corticosteroid
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with dry cough sustaining for more than 3 weeks, without apparent cause of cough evident from history, physical examination, chest X-ray, or spirometry
Key exclusion criteria
1. hypersensitivity to budesonide
2. woman who is pregnant or during breast-feeding
3. on ACE inhibitor
4. patients with asthma which is active or under treatment
5. patients who the doctors consider inappropriate
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Asano |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
Address
35 Shinanomachi, Shinjukuku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Asano |
Organization
Keio University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
Address
TEL
Homepage URL
ko-asano@qa2.so-net.ne.jp
Sponsor or person
Institute
Division of Pulmonary Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Pulmonary Medicine, Keio University School of 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
| 2008 | Year | 02 | Month | 08 | 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
| 2008 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in preparation to start the study
Management information
Registered date
| 2008 | Year | 02 | Month | 06 | Day |
Last modified on
| 2011 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001230
