UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006551 |
|---|---|
| Receipt number | R000007763 |
| Scientific Title | Budesonide/formoterol combination therapy versus budesonide plus tulobuterol-patch therapy in elderly asthmatic patients: A randomized, comparative study |
| Date of disclosure of the study information | 2011/10/17 |
| Last modified on | 2017/04/24 11:13:01 |
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Basic information
Public title
Budesonide/formoterol combination therapy versus budesonide plus tulobuterol-patch therapy in elderly asthmatic patients: A randomized, comparative study
Acronym
A comparative study of budesonide/formoterol combination therapy in elderly asthmatic patients
Scientific Title
Budesonide/formoterol combination therapy versus budesonide plus tulobuterol-patch therapy in elderly asthmatic patients: A randomized, comparative study
Scientific Title:Acronym
A comparative study of budesonide/formoterol combination therapy in elderly asthmatic patients
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and safety of budesonide/formoterol combination therapy with budesonide plus tulobuterol-patch therapy in elderly asthmatic patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement in the ACQ(asthma control questionnaire) score after 12 weeks
Key secondary outcomes
Change of various indicator as follow
1) Fraction of exhaled Nitric Oxide
2) Lung function(FEV1.0 etc)
3) Asthma relevant QOL (miniAQLQ score)
4) Night-time awaking due to asthma
5) Symptom-free days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Budesonide/formoterol group
Symbicort Turbuhaler 160/4.5ug two inhalations, twice daily for 12 weeks
Interventions/Control_2
Budesonid + turobuterol-patch group Pulmicort Turbuhaler 200ug two inhalations, twice daily + tulobuterol-patch (1 or 2mg) once daily for 12 weeks
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
1) Signed informed consent
2) Outpatients over 65 years old with asthma
3) Who have been using Adoair 50/100ug or 50/250ug one inhalation twice daily or ICS (low or moderate dose) at least for over 4 weeks
4) ACQ > 0.75 or %FEV1pred < 80%
Key exclusion criteria
1) Patients with a history of hypersensitivity(e.g contact dermatitis) to any ingredient contained in the budesonide/formoterol combination
2) Patients with a history of hypersensitivity to any ingredient contained in the tulobuterol-patch
3) Patients with infectious with no availabl effective antimicrobial drugs or with deep-seated mycosis
4) Patients with other respiratory illnesses(lung cancer, tuberculosis, bronchiectasis etc)
5) Patients with heart failure
6) Patients with RE
7) %FEV1<60%
8) Patients who contracted a respiratory infection that could influence asthma within the last 4 weeks
9) Patients who were treated with systemic corticosteroids in the last 4 weeks
10) Patients who are taking high-dose ICS
11) Patients who are taking PSL
12) Patients who are taking inhaled anticholinergic drugs
13) Patients who are treated with ZOREA(omalizumab)
14) Patients with other severe diseases
15) Patients who are considered inappropriate by the physician in charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto Matsuse |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7273
midukipapa2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kawano |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1, Sakamoto, Nagasaki, Japan
TEL
095-819-7273
Homepage URL
midukipapa2002@yahoo.co.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Nagasaki University Hospital
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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 17 | 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
| 2011 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 17 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007763
