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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034699
Receipt No. R000039555
Official scientific title of the study 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

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Basic information
Official scientific title of the study Therapy with macrolide in severe asthmatic patients with peripheral blood neutrophilia: a non-blinded, crossover trial
Title of the study (Brief title) 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 Masaki Tamura
Organization Kyorin University Faculty of Medicine
Division name First Department of Internal Medicine (Respiratory Medicine)
Address 6-20-2, Shinkawa,Mitaka-shi,Tokyo
TEL 0422-47-5511
Email masakit@ks.kyorin-u.ac.jp

Public contact
Name of contact person Masato Watanabe
Organization Kyorin University Faculty of Medicine
Division name First Department of Internal Medicine (Respiratory Medicine)
Address 6-20-2, Shinkawa,Mitaka-shi,Tokyo
TEL 0422-47-5511
Homepage URL
Email masato@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039555

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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