UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006826
Receipt number 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 00:15:14

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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