UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.
Title of the study (Brief title)	Study on drug concentration in serum and sputum and clinical effects in patients receiving long-term drug therapy of pulmonary Mycobacterium avium complex disease.
Region	Japan

Condition
Condition	Pulmonary Mycobacterium avium complex disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate relationship between changes of serum and sputum concentration and efficacy and safety in therapeutic drugs for pulmonary Mycobacterium avium complex disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum and sputum concentration of therapeutic drugs and their metabolites for pulmonary Mycobacterium avium complex disease. Clinical symptoms of subjects (cough, sputum and hemosputum etc.), chest radiographic findings, examination of sputum (smear and culture) and clinical laboratory test results.
Key secondary outcomes	The ratio of urinary 6beta hydroxycortisol/free cortisol.

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	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients who were diagnosed with pulmonary Mycobacterium avium complex disease. 2) Patients receiving drug therapy of pulmonary Mycobacterium avium complex disease more than three months. 3) Subjects who understood the requirements of the study and signed the informed consent forms.
Key exclusion criteria	1) Subjects whose PS(Performance Status)are over 7 accordance with the Ordinance of the Ministry of Health, Labour and Welfare. 2) Subjects who had in the past or currently have following diseases. ;hepatic or renal diseases ;other diseases which doctor in attendance considered to influence in results of study, or be penalized by administration of clarithromycin, rifampicin and ethambutol. 3) Subjects who consumed excessive amounts of coffee or beverage containing caffeine.(over eight cups a day) 4) Drug or alcohol abuser. 5) Illegal drug constant user. 6) Men and women who donated two hundred milliliter of blood within four weeks prior to commencement of this study, or men who donated four hundred milliliter of blood within twelve weeks prior to commencement of this study, and women who donated four hundred milliliter of blood within sixteen weeks prior to commencement of this study. 7) Subjects who participated in another clinical trials with an investigational agent within four weeks prior to commencement of this study. 8) Subjects who had history of hypersensitivity to constituent of RIFADIN CAPSULES, CLARITH TABLETS and ESANBUTOL TABLETS. 9) Subjects who are judged as inadequate by doctor in attendance.
Target sample size	50

Research contact person
Name of lead principal investigator	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
Address	2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL	04-7124-1501
Email	t-aoyama@rs.noda.tus.ac.jp

Public contact
Name of contact person	Takao Aoyama
Organization	Tokyo University of Science
Division name	Faculty of Pharmaceutical Sciences
Address	2641 Yamazaki Noda City, Chiba Pref., 278-8510, Japan
TEL	04-7124-1501
Homepage URL
Email	t-aoyama@rs.noda.tus.ac.jp

Sponsor
Institute	Laboratory of pharmacotherapeutics, Tokyo University of Science
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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Chemotherapy research institute, Kaken hospital
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	化学療法研究所附属病院（千葉県）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 16 Day
Anticipated trial start date	2013 Year 05 Month 17 Day
Last follow-up date	2016 Year 03 Month 31 Day
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	Serum and sputum concentration of therapeutic drugs and their metabolites for pulmonary Mycobacterium avium complex disease.

Management information
Registered date	2013 Year 05 Month 16 Day
Last modified on	2016 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012556