UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034699 |
|---|---|
| Receipt number | R000039555 |
| Scientific Title | Therapy with macrolide in severe asthmatic patients with peripheral blood neutrophilia: a non-blinded, crossover trial |
| Date of disclosure of the study information | 2018/11/02 |
| Last modified on | 2018/10/30 11:55:47 |
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Basic information
Public title
Therapy with macrolide in severe asthmatic patients with peripheral blood neutrophilia: a non-blinded, crossover trial
Acronym
MSAPN study
Scientific Title
Therapy with macrolide in severe asthmatic patients with peripheral blood neutrophilia: a non-blinded, crossover trial
Scientific Title:Acronym
MSAPN study
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of macrolide in severe asthmatic patients with peripheral blood neutrophilia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exacerbation of asthma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Standard therapy (the participants have used before participating the study) plus Clarithromycin 200 mg/day for 12 weeks, followed by Standard therapy alone for 12 weeks.
Interventions/Control_2
Standard therapy (the participants have used before participating the study) alone for 12 weeks, followed by Standard therapy plus Clarithromycin 200 mg/day for 12 weeks.
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 are diagnosed with asthma according to guidelines of The Japanese Respiratory Society and Japanese Society of Allergy.
2. Patients who meet our criteria of severe asthma with peripheral blood neutrophilia (white blood cell count >= 8,000 /microliter, neutrophil count >= 6,000 /microliter, or eosinophil count >= 72/microliter).
3. Patients who understand the purpose of the study and gave written informed consent.
4. Patients who are 20 years old or older.
Key exclusion criteria
1. Patients with chronic obstructive lung disease.
2. Patient who smoked within three months.
3. Patients whose attending physician recommends not to participate the study because of comorbidities (i.e. respiratory infection, heart disease, liver disease, and kidney disease)
4. Patients with non-tuberculotic mycobacterial infection.
5. Patients who cannot use clarithromycin: with history of hypersensitivity to clarithromycin; using presently pimozide, Ergotamine Tartrate, Dihydroergotamine Mesilate, Tadalafil, Asunaprevir, Vaniprevir, or Suvorexant; with liver or kidney disease and using presently Colchicine.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Tamura |
Organization
Kyorin University Faculty of Medicine
Division name
First Department of Internal Medicine (Respiratory Medicine)
Zip code
Address
6-20-2, Shinkawa,Mitaka-shi,Tokyo
TEL
0422-47-5511
masakit@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Watanabe |
Organization
Kyorin University Faculty of Medicine
Division name
First Department of Internal Medicine (Respiratory Medicine)
Zip code
Address
6-20-2, Shinkawa,Mitaka-shi,Tokyo
TEL
0422-47-5511
Homepage URL
masato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Japan Science Foundation
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
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
| 2018 | Year | 11 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2018 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039555
