UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005895 |
|---|---|
| Receipt number | R000006960 |
| Scientific Title | Open label multicenter study: Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients. |
| Date of disclosure of the study information | 2011/09/10 |
| Last modified on | 2011/06/30 16:39:19 |
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Basic information
Public title
Open label multicenter study: Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients.
Acronym
Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients.
Scientific Title
Open label multicenter study: Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients.
Scientific Title:Acronym
Efficacy and safety of budesonide / formoterol combination in elderly asthmatic patients.
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate to efficacy and safety of budesonide / formoterol combination 4inh/day in elderly asthmatic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of ACQ(asthma control questionnaire) score for 8 weeks using budesonide / formoterol combination
Key secondary outcomes
Change of various indicators as follows:
1)Fraction of exhaled Nitric Oxide
2)Asthma relevant QOL (miniAQLQ score)
3)24h Holter ECG
(PVC; Premature Ventricular Contraction / heart rate)
4)Blood pressure (SBP / DBP)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Budesonide / formoterol combination dry powder inhalation 4inh/day for 8 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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Asthmatic Patients using Fluticasone / salmeterol 250/50 2inh/day continually at least recent 2 months.
Key exclusion criteria
1)Patients who used exclusion drugs within previous 4 weeks.
2) Patients who used beta-blockers within previous 4 weeks.
3)Current smoker, smoked within previous 6 months or had smoked more than 10 pack-years in the past.
4)Tachyarrhythmia
5)Patients who are considered inappropriate by physicians in charge.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Kadowaki |
Organization
National Hospital Organization Matsue Medical Center
Division name
Depertment of Pulmonary Depertment of Pulmonary Medicine
Zip code
Address
5-8-31 Agenogi, Matue, Shimane, Japan
TEL
0852-21-6131
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Kadowaki |
Organization
National Hospital Organization Matsue Medical Center
Division name
Depertment of Pulmonary Medicine
Zip code
Address
5-8-31 Agenogi, Matue, Shimane, Japan
TEL
0852-21-6131
Homepage URL
toruyan@matsue.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Matsue Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
独立行政法人国立病院機構 松江医療センター、愛媛大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 30 | Day |
Last modified on
| 2011 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006960
