UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of budesonide therapy on airway hypersecretion and/or sputum excretion failure in asthma patients; open label study
Title of the study (Brief title)	The effects of budesonide therapy on sputum excretion failure in asthma patient
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of budesonide therapy a on airway hypersecretion and/or sputum excretion failure in Japanese patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Changes in m-CASA-Q efficacy(%) from before to after 8 weeks treatment
Key secondary outcomes	Changes in lung function (%FEV1/%PEF) from before to after 8 weeks treatment Changes in eosinophil and neutrophil from before to after 8 weeks treatment Changes in ECP and mucin from before to after 8 weeks treatment

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Budesonide group Budesonide 200micro;g two inhalations bid (morning and evening)
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- Signed informed consent by the patient - Outpatient, man or woman, 20 years or older - Diagnosis of asthma - Sputum over the past 8 weeks patien
Key exclusion criteria	- Patients with a history of hypersensitivity (including contact dermatitis) to any ingredient contained in the study drugs - Patients with infections with no available effective antimicrobial drugs or with deep seated mycosis - Patients with tuberculosis - Respiratory infection, judged by the investigator as an infection affecting the asthma, within 8 weeks prior to enrollment - Use of any beta-blocking agents - Treatment with oral, parenteral or rectal steroids within 30 days prior to enrollment - Any significant disease or disorder judged by the investigator - Current or previous with a smoking
Target sample size	30

Research contact person
Name of lead principal investigator	Jun Tamaoki
Organization	Tokyo Women's Medical University
Division name	Respiratory Medicine
Address	8-1 Kawada-Cho, Shinjuku, Tokyo
TEL	03-3353-8111
Email	jtamaoki@chi.twmu.ac.jp

Public contact
Name of contact person	Jun Tamaoki
Organization	Tokyo Women's Medical University
Division name	Respiratory Medicine
Address	8-1 Kawada-Cho, Shinjuku, Tokyo
TEL	03-3353-8111
Homepage URL
Email	jtamaoki@chi.twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 08 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	2016 Year 07 Month 11 Day
Last modified on	2016 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026634