UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003805 |
|---|---|
| Receipt number | R000004596 |
| Scientific Title | Improved effects of Budesonide/Formoterol combination therapy (Symbicort) on the residual eosinophilic inflammation in the distal airways of asthmatic patients who used the salmeterol/fluticasone combination drug |
| Date of disclosure of the study information | 2010/06/24 |
| Last modified on | 2013/12/05 00:16:23 |
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Basic information
Public title
Improved effects of Budesonide/Formoterol combination therapy (Symbicort) on the residual eosinophilic inflammation in the distal airways of asthmatic patients who used the salmeterol/fluticasone combination drug
Acronym
Effects of Budesonide/Formoterol combination therapy (Symbicort) on the distal airway inflammation
Scientific Title
Improved effects of Budesonide/Formoterol combination therapy (Symbicort) on the residual eosinophilic inflammation in the distal airways of asthmatic patients who used the salmeterol/fluticasone combination drug
Scientific Title:Acronym
Effects of Budesonide/Formoterol combination therapy (Symbicort) on the distal airway inflammation
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improved effects of Symbicort on distal airway inflammation in well-controlled asthmatic patients who used salmeterol/fluticasone combination drug.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
distal airway inflammation in induced sputum (Eosinophil counts, ECP and SPD)
Key secondary outcomes
Asthma related QOL(AQLQ), impulse oscillometry system (IOS), FeNO, Pulmonary function test, Eosinophils in peripheral blood
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
We evaluate the improved effects of Symbicort on the residual airway inflammation in the distal airway of the well-controlled asthmatic patients who used salmeterol/fluticasone combination drug.
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
1. Patients who regularly used salmeterol/fluticasone combination drug more than 3 months.
2. Stable well-controlled asthmatic patients
Key exclusion criteria
1. Past history of asthma attach in the previous 3 months.
2. Past treatments with oral corticosteroids in the previous 2 weeks.
3. Chronic obstructive lung disease (COPD) and other respiratory disease.
4. Severe liver, kidney, heart, hematic and other diseases
5. Inappropriate patients from the doctor's viewpoint
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
JA Tohno Kousei Hospital
Division name
Allergy and Respiratory Medicine
Zip code
Address
76-1, Toki-Cho, Mizunami City, Gifu Pref., 509-6101, Japan
TEL
0572-68-4111
ohbayasi@nn.iij4u.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
JA Tohno Kousei Hospital
Division name
Allergy and Respiratory Medicine
Zip code
Address
76-1, Toki-Cho, Mizunami City, Gifu Pref., 509-6101, Japan
TEL
0572-68-4111
Homepage URL
ohbayasi@nn.iij4u.or.jp
Sponsor or person
Institute
JA Tohno Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
JA Tohno Kousei Hospital
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
| 2010 | Year | 06 | Month | 24 | 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
| 2009 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2013 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004596
