UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011811 |
|---|---|
| Receipt number | R000013777 |
| Scientific Title | The effect of Esomeprazole to asthma control in asthma patients with GERD taking inhaled corticosteroid |
| Date of disclosure of the study information | 2013/09/19 |
| Last modified on | 2013/09/20 16:03:22 |
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Basic information
Public title
The effect of Esomeprazole to asthma control in asthma patients with GERD taking inhaled corticosteroid
Acronym
The effect of PPI in asthmatics with GERD
Scientific Title
The effect of Esomeprazole to asthma control in asthma patients with GERD taking inhaled corticosteroid
Scientific Title:Acronym
The effect of PPI in asthmatics with GERD
Region
| Japan |
Condition
Condition
Bronchial asthma with gastroesophageal reflux disease(GERD)
Classification by specialty
| Gastroenterology | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Esomeprazole (EPZ) to asthma control in asthmatics with GERD and the safety of EPZ.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of %FEV1 12 weeks after the introduction of EPZ.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Asthmatics with GERD are treated with Esomeprazole (EPZ)(20mg) daily for 12 weeks.
Interventions/Control_2
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
In patients with bronchial asthma, all of the following criteria was required for enrollment
(1)age:20 years or more
(2)receiving inhaled corticosteroid for at least 4 weeks
(3)diagnosed with GERD by Gerd Q or FSSG
Key exclusion criteria
(1)hypersensitivity to EPZ or other PPI
(2)treated with atazanavir sulfate
(3)hypersensitivity to drugs
(4)severe disease in liver, kidney, heart
(5)severe symptom in gastrointestinal tract(hematemesis, hemorrhagic stool, severe anemia, sudden weight loss)
(6)past history of gastrointestinal tract resection, vagotomy, lung resection
(7)in combination with other PPI or histamine H2 antagonist
(8)not treated with systemic steroid for 3 months before the enrollment
(9)decided to be unsuitable to enrollment by physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Yokoyama |
Organization
Kochi University School of Medicine
Division name
Department of Hematology and Respiratory Medicine
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2345
ayokoyama@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shintaro Miyamoto |
Organization
Kochi University School of Medicine
Division name
Department of Hematology and Respiratory Medicine
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2345
Homepage URL
miyamoto@kochi-u.ac.jp
Sponsor or person
Institute
Department of Hematology and Respiratory Medicine in Kochi University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology and Respiratory Medicine in Kochi University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2013 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013777
