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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011811
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email miyamoto@kochi-u.ac.jp

Sponsor
Institute Department of Hematology and Respiratory Medicine in Kochi University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013777


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