UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Budesonide/formoterol combination therapy versus budesonide plus tulobuterol-patch therapy in elderly asthmatic patients: A randomized, comparative study
Title of the study (Brief title)	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	Hiroto Matsuse
Organization	Nagasaki University Hospital
Division name	Second Department of Internal Medicine
Address	1-7-1, Sakamoto, Nagasaki, Japan
TEL	095-819-7273
Email	midukipapa2002@yahoo.co.jp

Public contact
Name of contact person	Tetsuya Kawano
Organization	Nagasaki University Hospital
Division name	Second Department of Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000007763