UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046728 |
|---|---|
| Receipt number | R000053311 |
| Scientific Title | An exploratory research of pathophysiological relationship between airway and gastrointestinal tract mediated by sensory neuronal dysfunction in asthma with functional gastrointestinal disorders |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/07/29 20:31:36 |
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Basic information
Public title
An exploratory research of pathophysiological relationship between airway and gastrointestinal tract mediated by sensory neuronal dysfunction in asthma with functional gastrointestinal disorders
Acronym
Sensory neuronal dysfunction in asthma with functional gastrointestinal disorders
Scientific Title
An exploratory research of pathophysiological relationship between airway and gastrointestinal tract mediated by sensory neuronal dysfunction in asthma with functional gastrointestinal disorders
Scientific Title:Acronym
Sensory neuronal dysfunction in asthma with functional gastrointestinal disorders
Region
| Japan |
Condition
Condition
Asthma, Functional gastrointestinal disorders(FGIDs), Functional dyspepsia(FD)
Classification by specialty
| Gastroenterology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the characteristics of asthma phenotypes with airway sensory neuronal dysfunction and establish the clinical significance of comorbid functional gastrointestinal disorders with asthma.
Basic objectives2
Others
Basic objectives -Others
To explore neurophysiological pathologic correlations between asthma and functional gastrointestinal disorders disorders.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. To compare capsaicin cough sensitivity between asthmatic patients with and without comorbid FGIDs.
Key secondary outcomes
1. To compare clinical backgrounds and inflammation phenotype(peripheral blood eosinophil and neutrophil counts, exhaled nitric oxide concentration, sputum eosinophil and neutrophil counts, cytokines in serum and sputum) between asthmatic patients with and without comorbid FGIDs.
2. To examine the association of capsaicin cough sensitivity, airway inflammation, and other clinical backgrounds with gastric mucosal inflammation, neuronal remodeling, neuropeptide expression, and TRPV1 expression in asthmatic patients with comorbid FGIDs.
3. To explore factors associated with airway neuronal dysfunction (heightened capsaicin cough sensitivity) in asthmatic patients.
4. To compare gastric mucosal inflammation, neuronal remodeling, neuropeptide expression, and TRPV1 expression between patients with FGIDs with and without comorbid asthma.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients attending our outpatient clinic for asthma and chronic cough or outpatient clinic for functional gastroenteropathy
2. Patients with asthma, cough predominant asthma or cough variant asthma, functional dyspepsia, irritable bowel syndrome
Key exclusion criteria
1. Current smokers or past smokers of 20 pack-years or more
2. Patients with other obvious respiratory complications such as lung cancer, interstitial lung disease, etc.
3. Patients with other obvious organic gastrointestinal complications such as gastric cancer, gastroduodenal ulcer, colorectal cancer, inflammatory bowel disease, etc.
4. Patients who have taken non-steroidal anti-inflammatory drugs within the past 6 months
5. Patients with a history of gastrointestinal tract surgery
6. Pregnant or lactating patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
kaney32@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takehiro |
| Middle name | |
| Last name | Uemura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8216
Homepage URL
t50uemu@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
MSD Life Science Foundation, Public Interest Incorporated Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
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
| 2022 | Year | 02 | Month | 01 | 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
55
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
Main results already published
Date of protocol fixation
| 2021 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Research Flow]
This is a cross-sectional study, and patients are prospectively enrolled. Asthmatic patients will undergo peripheral blood eosinophil and neutrophil counts, total and specific IgE levels, serum preservation, spirometry, airway reversibility test, exhaled nitric oxide concentration measurement, induced sputum test, and capsaicin cough sensitivity test at the time of inclusion. Upper gastrointestinal endoscopy is performed in asthmatic patients with upper gastrointestinal symptoms and suspected comorbid FGIDs. In addition to routine examination, three mucosal biopsies from the normal gastric mucosa are performed for research purposes. The patients will then be included in the asthma group with and without comorbid FGIDs according to the examination by a gastroenterologist. Patients with FGIDs without comorbid asthma will undergo upper gastrointestinal endoscopy at the time of inclusion, and three mucosal biopsies will be taken from the normal gastric mucosa for research purposes.
Management information
Registered date
| 2022 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053311
