UMIN-CTR Clinical Trial

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