UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006234 |
|---|---|
| Receipt number | R000007345 |
| Scientific Title | Effect of Carbocisteine on Common Cold Morbidity in Asthma Patients |
| Date of disclosure of the study information | 2011/08/26 |
| Last modified on | 2011/08/26 10:01:54 |
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Basic information
Public title
Effect of Carbocisteine on Common Cold Morbidity in Asthma Patients
Acronym
Effect of Carbocisteine on Common Cold Morbidity in Asthma Patients
Scientific Title
Effect of Carbocisteine on Common Cold Morbidity in Asthma Patients
Scientific Title:Acronym
Effect of Carbocisteine on Common Cold Morbidity in Asthma Patients
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was conducted to evaluate the effect of carbocisteine on the frequency of the common cold and acute exacerbations in asthma patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of the common cold
Key secondary outcomes
1. Frequency of acute exacerbation
2. Cumulative percentage of patients with first acute exacerbation
3. Peak expiratory flow [PEF] rate upon morning and evening
4. Pulmonary function (forced vital capacity [FVC], forced expiratory volume [FEV] 1.0, FEV 1.0%, and % FEV 1.0 )
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In addition to asthma controller medications at the time of enrollment, carbocisteine 500 mg x 3/day (after meals) was added.
Interventions/Control_2
Asthma controller medications at the time of enrollment was continued.
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
Patients diagnosed with mild to moderate persistent asthma based on the "Classification of Asthma Severity in View of Current Treatment (in adult)" in the 2006 Asthma Prevention and Management Guideline (Japan )
Key exclusion criteria
1) patients intolerant to carbocisteine; 2) patients planned to take oral steroids, antibacterials/antibiotics, antitussives, or expectorants at the start of the study; 3) patients participating in another study at the start of the study; 4) patients who had started hyposensitization therapy or nonspecific therapy within 3 months or who planned on such therapy after the start of the study; 5) patients with comorbidities such as COPD or bronchiectasis; 6) patients with serious hepatic disease, renal disorders, heart disease, or other comorbidities; 7) patients with malignant tumors; 8) patients who were or may have been pregnant; 9) lactating patients; 10) patients determined unsuitable by an investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Fukuda |
Organization
Dokkyo Medical University
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi 321-0293 , Japan
TEL
0282-86-1111(+81-282-86-1111)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ritsuko Kondo |
Organization
WILL Medical Communications Inc.
Division name
Editorial Dept
Zip code
Address
3-1-10-902, Hiranomachi, Chuoku, Osaka 541-0046, Japan
TEL
06-4706-7604(+81-6-4706-7604)
Homepage URL
Sponsor or person
Institute
Dokkyo Medical University, Department of Pulmonary Medicine and Clinical Immunology
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaceutical Co.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
獨協医科大学（栃木県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 26 | Day |
Last modified on
| 2011 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007345
