UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017533 |
|---|---|
| Receipt number | R000016958 |
| Scientific Title | Pathological evaluation of asthma with rhinitis or rhinosinusitis by measuring fractional exhaled nitric oxide (FeNO)and nasal nitric oxide (nasal NO). |
| Date of disclosure of the study information | 2015/05/12 |
| Last modified on | 2016/06/20 17:07:11 |
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Basic information
Public title
Pathological evaluation of asthma with rhinitis or rhinosinusitis by measuring fractional exhaled nitric oxide (FeNO)and nasal nitric oxide (nasal NO).
Acronym
Eevaluation of asthma by nasal NO.
Scientific Title
Pathological evaluation of asthma with rhinitis or rhinosinusitis by measuring fractional exhaled nitric oxide (FeNO)and nasal nitric oxide (nasal NO).
Scientific Title:Acronym
Eevaluation of asthma by nasal NO.
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology | Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To evaluate the usefulness of nasal nitric oxide(NO) measurements as one of the method of the upper airway inflammation in asthmatic patients with rhinitis or rhinosinusitis.
2. To evaluate the localization and distribution of inflammation in the airways by measuring NO from both upper and lower respiratory tract, and to investigate the association between nitric oxide (FeNO, nasal NO) concentration and clinical feature of asthma, long-term prognosis.
3. To revreal pathogenesis of asthma with allergic rhinitis and chronic rhinosinusitisi by measuring the cellular and liquid components of the nasal lavage, blood and sputum samples.
4. To evaluate the association between serum periostin levels and comorbid upper airway diseases (rhinitis, chronic rhinosinusitis)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Asssociation between asthma severity and FeNO, nasal NO in asthmatic patients with rhinitis.
Key secondary outcomes
1. Correlation between nasal NO levels and otolaryngologic disease.
2. Relationship between response of FeNO/nasal NO levels and changes of asthma and rhinitis symptoms due to rhinitis treatment.
3. Correlation between nasal NO/FeNO levels and cellular components, liquid factor of nasal lavage, blood, and sputum.
4. The effect of nasal NO levels in allergic rhinitis and chronic rhinosinusitis on the presence or absence of asthma.
5. Associations of rhinitis or chronic rhinosinusitis to serum periostin levels
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjective: Stable asthmatic patients presenting symptoms as related with untreated allergic rhinitis or chronic rhinosinusitis.
Control group:
1. Asthmatic patients without symptoms as related with rhinitis.
2. Allergic rhinitis patients without asthma.
3. Chronic rhinosinusitis patients without asthma.
4. healthy volunteer
Key exclusion criteria
1. Patients who are considered to have infectious disease like mycobacterium tuberculosis.
2. Current smoker, and ex-smoker with smoking history more than 5 pack-year.
3. Patients who can not perform laboratory tests correctly.
4. Patients who has oral steroids at the registration period.
Except for the patients who had 2 weeks washout peroiod prior to registration.
5. Patients who was judged as inappropriate by investigators
Target sample size
346
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Niimi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Respiratory Medicine, Allergy and Rheumatology
Zip code
Address
1, kawasumi, mizuho-cho, mizuho-ku, Nagoya-city
TEL
052-851-5511
a.niimi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamitsu Asano |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Respiratory Medicine, Allergy and Rheumatology
Zip code
Address
1, kawasumi, mizuho-cho, mizuho-ku, Nagoya-city
TEL
052-851-5511
Homepage URL
t.asano@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences Respiratory Medicine, Allergy and Rheumatology
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
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
| 2015 | Year | 05 | Month | 12 | 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
Nasa NO values are signignificantly higher in asthmatic patients with rhinitis than those without upper airway diseases or those with chronic rhinosinusitis, suggesting the utility of nasal NO measurements for diagnosing comorbid rhinitis in asthmatic patients. No significant differences were found in nasal NO values between those wit and without asthma. Therefore, nasal NO values seem to be specific to upper airway inflammation. Nasal No values did not associate with the severity of rhinitis. In contrast, nasal NO values were inversely correlated with severity of rhinosinusitis (sinus CT scoring) and asthma control (ACQ scores). When evaluating other biomarkers, serum periostin levels were higher in patients with CRS compared to those without upper airway diseases or those with rhinitis.
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
| 2014 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
No information are given at this moment.
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016958
