UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathological evaluation of asthma with rhinitis or rhinosinusitis by measuring fractional exhaled nitric oxide (FeNO)and nasal nitric oxide (nasal NO).
Title of the study (Brief title)	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

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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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Akio Niimi
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Respiratory Medicine, Allergy and Rheumatology
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	Takamitsu Asano
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Respiratory Medicine, Allergy and Rheumatology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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