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
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
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
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
