UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035749 |
|---|---|
| Receipt number | R000040723 |
| Scientific Title | The study of Involvement of Adenosine Triphosphate in Sputum in Pathophysiology of Asthma |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2023/02/11 13:02:11 |
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Basic information
Public title
The study of Involvement of Adenosine Triphosphate in Sputum in Pathophysiology of Asthma
Acronym
The study of Involvement of Adenosine Triphosphate in Sputum in Pathophysiology of Asthma
Scientific Title
The study of Involvement of Adenosine Triphosphate in Sputum in Pathophysiology of Asthma
Scientific Title:Acronym
The study of Involvement of Adenosine Triphosphate in Sputum in Pathophysiology of Asthma
Region
| Japan |
Condition
Condition
Bronchial asthma, COPD
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are several evidences that the danger-signaling, molecule adenosine triphosphate (ATP) plays a pivotal role in allergic bronchial inflammation. ATP in BAL elevated in patients with COPD and related with severity of COPD. Little is known regarding clinical implication of ATP in airway secretions in asthma. We investigated the association between ATP in sputum and clinical indices in asthma.
Basic objectives2
Others
Basic objectives -Others
Contribution of ATP in sputum to clinical pathophysiology in asthma
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Contribution of ATP in sputum to clinical pathophysiology in asthma
Measure ATP in induced sputum to determine whether concentrations of them increase in patients with asthma.
Key secondary outcomes
Association between ATP in sputum and following clinical parameters: severity, pulmonary function, cell counts in induced sputum, exhaled oxide concentrations, cytokines, chemokines, granule proteins
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
1) Patients who satisfy the daiagnostic criteria of bronchial asthma in the Japanese Asthma guideline 2012
2) Patients who satisfy the daiagnostic criteria of COPD in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013.
3) Healthy volunteer
4) Participants with SpO2>94%
5) Participants from whom written consent has been obtained
6) Patients with asthma who satisfy the presence of a clinical history regarding asthma (symptom, history of exacerbation, and physical examination) within the past year and any one of the following items:a) bronchial reversibility reflected by bronchodilator responsiveness, b) bronchial reversibility reflected by bronchodilator responsiveness
7) Patients with COPD who have FEV1/FVC ratio < 70% after bronchodilator inhalation and satisfy any one of the following items:a)Smoking history (>= 10 pack-years) or air pollution exposure, b) Presence of the hyperinflation or/and the flattening diaphragm on chest X-ray or the low attenuation area on chest CT demonstrating emphysematous change
Key exclusion criteria
1) Patients who have exacerbations of asthma or COPD within the last 4 weeks
a)Asthma exacerbation: oral corticosteroids administrated for more than 2 days because of having cough and sputum ,and/or more than 20% decrease of expiratory peak flow vales for consecutive 3 days
b) COPD exacerbation: exhibition of increased shortness of breathing, increased cough and sputum that result in a change of treatment
2) Patients with allergic bronchial pulmonary aspergillosis or eosinophilic granulomatosis with polyangitis
3) Patients with following disorders: severe heart diseases, severe renal diseases, neurological diseases
4) Pregnancy or lactation
5) Patients who are considered unsuitable for enrollment in this study by physicians in charge
Target sample size
215
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Soma |
Organization
Saitama Medical University
Division name
Department of Respiratory Medicine and Allergy Center
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
TEL
049-276-1111
tsoma@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Soma |
Organization
Saitama Medical University
Division name
Department of Respiratory Medicine and Allergy Center
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
TEL
049-276-1111
Homepage URL
tsoma@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
Tel
049-276-1111
hirb@saitama-med.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
埼玉医科大学病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
This study delays due to the pandemic of COVID-19.
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1)ATP in sputum significantly elevated in patients with asthma compared with controls.
2)ATP also significantly increased in 15 severe asthma subjects compared with 40 non-severe asthma.
3)ATP levels correlated with percentage of neutrophils in sputum.
4)The relation between ATP and percentage of neutrophils amplified in severe asthma.
Management information
Registered date
| 2019 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040723
