UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048438 |
|---|---|
| Receipt number | R000055200 |
| Scientific Title | An effect of azithromycin for exacerbation in asthma patients with obesity: the protocol for a multi-center, prospective single-arm intervention study |
| Date of disclosure of the study information | 2022/07/22 |
| Last modified on | 2023/01/21 09:26:28 |
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Basic information
Public title
An effect of azithromycin for exacerbation in asthma patients with obesity: the protocol for a multi-center, prospective single-arm intervention study
Acronym
An effect of azithromycin for exacerbation in asthma patients with obesity
Scientific Title
An effect of azithromycin for exacerbation in asthma patients with obesity: the protocol for a multi-center, prospective single-arm intervention study
Scientific Title:Acronym
An effect of azithromycin for exacerbation in asthma patients with obesity
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Obesity is one of the severity forms of asthma, however the specific treatment is not established. Gut microbiome is increasingly recognized as the crucial mechanisms however, specific treatments focused on gut microbiome is not established. Recently, azithromycin has capacity to attenuate exacerbation, which is severity characteristics of asthma. The effect of azithromycin for obesity induced severe asthma is not understood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endpoint is reduction of exacerbation rate after intervention of azithromycin for 48 weeks compared to that before the intervention. Here, the asthma exacerbation rate is defined as proportion of cases with asthma exacerbation after treatment among the analyzed cases.
Key secondary outcomes
Secondary endpoints are differences of clinical and laboratory parameters between before and after intervention of azithromycin including blood eosinophil ratio, eosinophil count, IgE, pulmonary functions such as vital capacity (VC), forced vital capacity (FVC), %VC, forced expiratory volume in one second (FEV1), FEV1%, %FEV1, and body weight, BMI, level of fractional exhaled nitric oxide (FeNO), scores of asthma control test. Another secondary endpoints are to clarify the characteristics of frequency for asthma exacerbation in improving/non-improving patients, and the diversity indexes of gut microbiome including Chao 1, Shannon, Simpson index. For other exploratory endpoints, height, bodyweight, BMI and tendency of attenuation effect for exacerbation are assessed at the time point of 24 weeks of the intervention of azithromycin. Additionally, biomarkers including cytokines, chemokines, short chain fatty acids, metabolomics and species of gut microbiome are compared between before and after intervention of azithromycin, and examined for relationships between the alteration and exacerbation at 48 weeks.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Azithromycin at 250mg daily for 48 weeks
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
Patients diagnosed to asthma whose age are more than 20 years old were included. All of the patients were more than 25 kg/m2 of BMI and experienced one or more times of moderate or severe exacerbation in previous year of the participant of present study. All of the patients should be obtained agreement for participation of present study on written informed consent.
Key exclusion criteria
Exclusion criteria will be: patients whose aspartate aminotransferase or alanine aminotransferase at more than 100 IU/L, creatinine at 2.0 mg/dL, who have life threatened arrhythmia or paroxysmal tachycardia at more than 100 times per minute of heart rate, who had been admitted by acute myocardial infarction or heart failure in previous year, who diagnosed malignancy in previous 5 years except for complete remission after the treatment, who treated by macrolide antibiotics in previous 4 week and biologics including omalizumab, mepolizumab, benralizumab, dupilumab in previous 8 weeks at initiation of the intervention of azithromycin in present study, whose QT interval requires correction for heart rate at more than 480 ms, who are pregnant or under breastfeeding, whose BMI at less than 25 kg/m2, and who decided ineligible for present study by researchers.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tashiro |
Organization
Saga University
Division name
Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Saga Prefecture
TEL
0952-34-2369
si3222@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Tashiro |
Organization
Saga University
Division name
Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty
Zip code
849-8501
Address
5-1-1 Nabeshima, Saga, Saga Prefecture
TEL
0952-34-2369
Homepage URL
si3222@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1 Nabeshima, Saga, Saga Prefecture
Tel
0952343357
kenkyu-shinsei@ml.cc.saga-u.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
佐賀大学医学部附属病院（佐賀県）、JCHO佐賀中部病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 22 | 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
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
| 2022 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055200
