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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006056
Receipt No. R000007167
Scientific Title Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol (160/4.5 mcg) fixed dosing (4 inhalations daily) and adjustable maintenance dosing (2 to 8 inhalations daily) in poorly controlled adult asthma patients
Date of disclosure of the study information 2011/08/01
Last modified on 2012/07/31

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Basic information
Public title Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol (160/4.5 mcg) fixed dosing (4 inhalations daily) and adjustable maintenance dosing (2 to 8 inhalations daily) in poorly controlled adult asthma patients
Acronym Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol fixed dosing and adjustable maintenance dosing in poorly controlled adult asthma patients
Scientific Title Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol (160/4.5 mcg) fixed dosing (4 inhalations daily) and adjustable maintenance dosing (2 to 8 inhalations daily) in poorly controlled adult asthma patients
Scientific Title:Acronym Randomized, open-label, parallel-group study for comparing efficacy of budesonide/formoterol fixed dosing and adjustable maintenance dosing in poorly controlled adult asthma patients
Region
Japan

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

Objectives
Narrative objectives1 This study is aimed to compare the efficacy of budesonide/formoterol fixed dosing with that of adjustable maintenance dosing in poorly controlled adult asthma patients who have been already treated with ICS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of the Asthma Control Questionnaire score
Key secondary outcomes - Respiratory function (FEV1)
- Total dose of budesonide/formoterol
- Mini Asthma Quality of Life Questionnaire score
- Number of adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with budesonide/formoterol (160/4.5 mcg) for 12 weeks, one to four inhalations, twice daily, dose is adjusted every 2 weeks if necessary
Interventions/Control_2 Treatment with budesonide/formoterol (160/4.5 mcg) for 12 weeks, two inhalations, twice daily, fixed dosing
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 - Patients with FEV1>= 60% predicted
- Patients who have received ICS for at least 4 weeks before enrollment
- Patients with average ACQ score >= 0.75
Key exclusion criteria - Patients who have past history of hypersensitivity (including contact dermatitis) to budesonide, formoterol, or any component of the combination
- Patients with infectious disease and/or deep mycosis that have no effective antimicrobial agent
- Patients with tuberculous disease
- Patients infected with influenza virus and/or lower respiratory tract infectious disease, which may affect asthma, within 2 weeks before the enrollment
- Patients using beta blocker including eye drops
- Patients who have taken systemic steroid within 2 week before the enrollment
- Patients with moderate to severe COPD classified with Global Initiative for Chronic Obstructive Lung Disease (moderate COPD: FEV1/FVC < 0.70, 50%<= FEV1<80% predicted)
- Current smoker
- Patients with clinically severe complication
- Planning-to-be-pregnant, pregnant or lactating patients
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukio Nagasaka
Organization Sakai Hospital, Kinki University School of Medicine
Division name General Internal Medicine
Zip code
Address 2-7-1, Harayamadai, Minami-ku, Sakai, Osaka
TEL 072-299-1120
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yukio Nagasaka
Organization Sakai Hospital, Kinki University School of Medicine
Division name General Internal Medicine
Zip code
Address 2-7-1, Harayamadai, Minami-ku, Sakai, Osaka
TEL 072-299-1120
Homepage URL
Email nagasaka@sakai.med.kindai.ac.jp

Sponsor
Institute Sakai Hospital, Kinki University School of Medicine
Institute
Department

Funding Source
Organization Japan Allergy Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 近畿大学医学部堺病院(大阪府)
植木病院(大阪府)
耳原総合病院(大阪府)
市立堺病院(大阪府)
佐々木内科クリニック(大阪府)
藤原内科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2011 Year 08 Month 01 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 07 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 08 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 07 Month 27 Day
Last modified on
2012 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007167

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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