UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008530 |
|---|---|
| Receipt number | R000010033 |
| Scientific Title | Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma. |
| Date of disclosure of the study information | 2012/07/26 |
| Last modified on | 2016/02/11 18:29:06 |
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Basic information
Public title
Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.
Acronym
Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.
Scientific Title
Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.
Scientific Title:Acronym
Randomized, open-label study to compare the effect of the compounds of inhaled corticosteroid and long-acting beta2 agonist on pulmonary function and symptomatic control in association with inspiratory flow in elderly patients with bronchial asthma.
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effect of budesonide/folmoterol compound and fluticasone/salmeterol compound in association with inspiratory flow.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of %FEV1.0 before and after the therapy for eight weeks.
Key secondary outcomes
Difference in Inspiratory flow and ACQ (Asthma Control Questionnaire) before and after the therapy for eight weeks.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Symbicot(R) 2puff, bid
Interventions/Control_2
Adair(R) 250 1puff,bid
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients matched below.
1. Patients with bronchial asthma.
2. Age >=65
3. Informed consent sheet have already been acquired.
4. %FEV1.0 <= 80% on pulmonary function test.
5. Patient with any asthmatic symptom, needed to strengthen the therapy, if the patient have already been treated only with inhaled corticosteroid.
6. Patient with any asthmatic symptom, needed to strengthen the therapy, if the patient have already been treated with low-dose ICS/LABA compound (Symbicot(R) 2 times/day, Adair(R) 100 2 times/day).
7. Outpatient
Key exclusion criteria
1. Contraindication to budesonide/formoterol or fluticasone /salmeterol compound.
2. High-dose ICS/LABA have already been prescribed (Symbicot(R) inhalation>=6 times/day or Adair(R) 500 inhalation).
3. Respiratory infection in last 4 weeks before enrollment.
4. Beta2 agonist in any form.
5. Systemic corticosteroid therapy in last 30 days before enrollment.
6. Any serious comorbidity.
7. Being or willing to be pregnant
8. Investigator judged as inappropriate for this study.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Yamaguchi |
Organization
The University of Tokyo Hospital
Division name
Department of Geriatric Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655
TEL
03-5800-8652
yamayasu-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Yamamoto |
Organization
Tokyo Metroporitan Geriatric Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
35-2 Sakaecho, Itabashi-ku, Tokyo, Japan 173-0015
TEL
03-3964-1141
Homepage URL
hyamamot-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2012 | Year | 07 | Month | 26 | 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
| 2012 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 25 | Day |
Last modified on
| 2016 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010033
