UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035749
Receipt No. 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 2019/02/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Soma
Organization Saitama Medical University
Division name Department of Respiratory Medicine and Allergy Center
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
TEL 049-276-1111
Email tsoma@saitama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomoyuki Soma
Organization Saitama Medical University
Division name Department of Respiratory Medicine and Allergy Center
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama 350-0495, Japan
TEL 049-276-1111
Homepage URL
Email tsoma@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
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 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
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 Open public recruiting
Date of protocol fixation
2013 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 10 Day
Last follow-up date
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
2019 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040723

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.