UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003250 |
|---|---|
| Receipt number | R000003931 |
| Scientific Title | Global evidence for asthma exacerbation in long term management |
| Date of disclosure of the study information | 2011/12/31 |
| Last modified on | 2012/01/11 10:59:49 |
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Basic information
Public title
Global evidence for asthma exacerbation in long term management
Acronym
GAIA Study
Scientific Title
Global evidence for asthma exacerbation in long term management
Scientific Title:Acronym
GAIA Study
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of carbocisteine on frequency of bronchial asthma exacerbation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of exacerbation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subjects will take one sachet of carbocisteine granules (containing 500 mg of L- carbocisteine per sachet) three times daily after meals for 48 weeks.
Interventions/Control_2
Subjects will take one sachet of placebo granules (not containing L- carbocisteine) three times daily after meals for 48 weeks.
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 >= 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.
- Patients who can receive the influenza vaccination during the study period
- Patients whose treatment can be matched to the asthma control level
- Patients who have a good understanding of the objectives of the study and who give written consent
[Treatment phase]
Patients who satisfy the following criteria in the observation phase:
- Patients with satisfactory treatment adherence (Patients with a compliance rate >= 70% for each antiasthmatic drug)
- Patients whose PEF measurements were performed at least 5 days/week
- Patients who made asthma diary entries at least 5 days/week
- Patients who satisfy the criteria for concomitant drugs and concomitant therapies in the observation phase
Key exclusion criteria
Patients to whom any of the following criteria apply will be excluded from the study:
[Observation phase] Visit 1
- Patients with definite COPD
- Patients who used continuously oral steroids or short-acting beta-2 receptor stimulants within one month prior to the observation phase (excluding cases when the drug was used to treat an exacerbation)
- Patients who contracted a respiratory infection within one month prior to the observation phase
- Patients who underwent hyposensitization therapy and used Omalizumab within three months prior to the observation phase
- Patients with a reported adverse event related to carbocisteine
- Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease
- Patients who are pregnant or who are at risk of pregnancy
- Patients with a malignancy
- Other patients deemed unsuitable by the principal investigator or investigator
According to The Global Initiative for Asthma (GINA) 2006, patients to whom the following apply:
- 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): <80% predicted value
For patients who experience three or more of the abovementioned conditions per week:
- Exacerbation: >= 1/week
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Terumasa Miyamoto |
Organization
Japan Clinical Allergy Research Institute
Division name
Director
Zip code
Address
2-16-1-423, Shinbashi, Minato-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
GAIA Study Research Group support center
Division name
GAIA Study Research Group support center
Zip code
Address
1-11-44 Akasaka, Minato-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
GAIA Study Research Group
Institute
Department
Personal name
Funding Source
Organization
GAIA Study Research Group
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 31 | 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 | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | 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
| 2010 | Year | 02 | Month | 24 | Day |
Last modified on
| 2012 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003931
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