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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008530
Receipt No. 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

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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
Email 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
Email hyamamot-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010033

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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