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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006290
Receipt No. R000007448
Scientific Title An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients
Date of disclosure of the study information 2011/09/15
Last modified on 2013/03/06

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Basic information
Public title An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients
Acronym A comparison of the changes in asthma control variables by budesonide versus budesonide/formoterol
Scientific Title An open-label, randomized, parallel group study to compare the changes in asthma control variables by budesonide vs. budesonide/formoterol in mild to moderate asthmatic patients
Scientific Title:Acronym A comparison of the changes in asthma control variables by budesonide versus budesonide/formoterol
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the degree of improvement on clinical variables for asthma (symptoms, airflow obstruction, airway hyperresponsivness, airway inflammation) by budesonide and budesonide/formoterol for the treatment of mild to moderate asthma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change from baseline (Week 0) in the airway hyperresponsiveness at Week 2, 4, 8 and 24
Key secondary outcomes Change from baseline (Week 0) in the following clinical variables at Week 2, 4, 8 and 24
1) ACQ
2) Respiratory function
3) Exhaled nitric oxide

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 Budesonide group
Pulmicort (200mcg) Turbuhaler one inhalation, twice daily for 24 weeks
Interventions/Control_2 Budesonide/formoterol group
Symbicort (160/4.5mcg) Turbuhaler one inhalation, twice daily for 24 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Adult outpatient with mild persistent and moderate asthma
2)Patient with inhaled steroid naive
3)Nonsmoking patient
4)Patients who has provided written consent prior to enrollment
Key exclusion criteria 1)Patients with a history of hypersensitivity (including contact dermatitis) to any ingredient contained in the budesonide/formoterol combination
2)Patients with infectious with no available effective antimicrobial drugs or with deep-seated mycosis
3)Patients with other respiratory illnesses (including lung cancer, tuberculosis, bronchiectasis)
4)Patients with heart failure
5)Patients who contracted a respiratory infection that could influence asthma within the last 4 weeks
6)Patients who ere treated with systemic corticosteroids in the last 4 weeks
7)Patients with RE
8)Patients with other severe diseases
9)Patients who are considered inappropriate by the physician in charge
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Ichinose
Organization Wakayama Medical University, School of Medicine
Division name Third Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuto Matsunaga
Organization Wakayama Medical University, School of Medicine
Division name Third Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email kazmatsu@wakayama-med.ac.jp

Sponsor
Institute Third Department of Internal Medicine, Wakayama Medical University, School of Medicine
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
2011 Year 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
BUD/FM showed a significant rapid improvement in asthma control than BUD alone.
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 08 Month 15 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 The results of this study has been reported in pulmonary pharmacology & therapeutics 2013, p189-p194.

Management information
Registered date
2011 Year 09 Month 06 Day
Last modified on
2013 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007448

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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