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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006551
Receipt No. 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

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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
Email 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
Email midukipapa2002@yahoo.co.jp

Sponsor
Institute Second Department of Internal Medicine, Nagasaki University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007763

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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