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 UMIN000006234
Receipt No. 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

* 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 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)
Email

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
Email

Sponsor
Institute Dokkyo Medical University, Department of Pulmonary Medicine and Clinical Immunology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.