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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017533
Receipt No. 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

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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
Email 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
Email t.asano@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016958

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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