UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006826
Receipt No. R000008079
Scientific Title Improved effects of Carbocisteine on the residual eosinophilic inflammation in the distal airways of asthmatic patients
Date of disclosure of the study information 2012/02/28
Last modified on 2013/12/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Improved effects of Carbocisteine on the residual eosinophilic inflammation in the distal airways of asthmatic patients
Acronym Effects of Carbocisteine on the distal airway inflammation
Scientific Title Improved effects of Carbocisteine on the residual eosinophilic inflammation in the distal airways of asthmatic patients
Scientific Title:Acronym Effects of Carbocisteine on the distal airway inflammation
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improved effects of Carbocisteine on the residual eosinophilic inflammation in the distal airways of asthmatic patients in a double-blind placebo-controld trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes change of inflammatory marker in induced sputum(eosinophil,ECP,SP-D,MMP-9/TIMP-1,TSLP)
Key secondary outcomes IOS(R5,R20,R5-R20,X5,Fres)
pulmonary function(FVC, FEV1.0, FEV1.0%, %FEV1.0)
FeNO
Asthma related QOL(ACT, AQLQ)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carbocisteine
Interventions/Control_2 Placebo
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 Observation phase
Males and females more than 20 yrs (at time of consent)
Outpatients
Patients with mild or moderate persistent asthma (according to the classification of asthma severity) taking into account current treatment.
Patients with at least one asthma exacerbation in the 12 months prior to the observation phase.
Patients with a morbidity period of one yr or more prior to the observation phase.
Patients who have not smoked for one yr or more prior to the observation phase.
An unequivocal diagnosis of bronchial asthma.
Key exclusion criteria Patients to whom any of the following criteria apply will be excluded from the study:
1)Patients with definite COPD
2)Patients who used continuously oral steroids or short-acting beta2 receptor stimulants within one month prior to the observation phase (excluding cases when the drug was used to treat an exacerbation)
3)Patients who contracted a respiratory infection within one month prior to the observation phase
4)Patients who underwent hyposensitization therapy and used Omalizumab within three months prior to the observation phase
5)Patients with a reported adverse event related to carbocisteine
6)Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease
7)Patients who are pregnant or who are at risk of pregnancy
8)Patients with a malignancy
9)According to The Global Initiative for Asthma (GINA) 2006, patients to whom the following apply:
Exacerbation:1/week
Daytime asthma symptoms:More than twice weekly
Limitations on activities: Yes
Nocturnal or early morning symptoms: Yes
Use of a bronchodilator for asthmatic attack: More than twice weekly
Respiratory function (FEV1.0):more than 80% predicted value
For patients who experience three or more of the abovementioned conditions per week:
10)Other patients deemed unsuitable by the principal investigator or investigator
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Ohbayashi
Organization Tohno Area Asthma Treatment Committee (TAT Com.) in Gifu
Tohno Chou Clinic
Division name Department of Respiratory and Allergy Medicine
Zip code
Address 1-14-1, Matsugase-Cho, Mizunami City, Gifu.
TEL +81-572-67-1118
Email ohbayasi@nn.iij4u.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Ohbayashi
Organization Tohno Area Asthma Treatment Committee (TAT Com.) in Gifu
Division name Department of Respiratory and Allergy Medicine
Zip code
Address 1-14-1, Matsugase-Cho, Mizunami City, Gifu
TEL 0572-67-1118
Homepage URL
Email ohbayasi@nn.iij4u.or.jp

Sponsor
Institute Tohno Area Asthma Treatment Committee (TAT Com.) in Gifu
Tohno Chou Clinic
Tohno Kousei Hospital
Institute
Department

Funding Source
Organization Tohno Area Asthma Treatment Committee Kyorin Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 02 Month 28 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 Completed
Date of protocol fixation
2010 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2011 Year 02 Month 01 Day
Date of closure to data entry
2013 Year 11 Month 30 Day
Date trial data considered complete
2013 Year 11 Month 30 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 04 Day
Last modified on
2013 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.