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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004465
Receipt No. R000005346
Scientific Title Efficacy and safety of budesonide/formoterol in patients with mild to moderate persistent asthma
Date of disclosure of the study information 2010/11/01
Last modified on 2011/10/27

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Basic information
Public title Efficacy and safety of budesonide/formoterol in patients with mild to moderate persistent asthma
Acronym Efficacy and safety of budesonide/formoterol in patients with mild to moderate persistent asthma
Scientific Title Efficacy and safety of budesonide/formoterol in patients with mild to moderate persistent asthma
Scientific Title:Acronym Efficacy and safety of budesonide/formoterol in patients with mild to moderate persistent asthma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy of a 12-week treatment with budesonide/formoterol in improving disease control defined by proportion of patients who achieved "controlled" according to the GINA guideline and lung function in mild to moderate persistent asthma, and also to evaluate the safety profile of this treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes (1) Proportion of patients who achieved "controlled" according to the GINA 2009 guideline at weeks 8 and 12 of study treatment
(2) Percent changes in lung function parameters (FEV1 and PEF) from week 0 to weeks 8 and 12 of study treatment
Key secondary outcomes (1) Changes in FeNO, PEF variability, FEV1, and each component of patient diary
(2) Correlations between the variables assessed and their time profile
(3) Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Budesonide/Formoterol 160/4.5 mcg, two inhalations, twice a day
Interventions/Control_2
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria [At start of observation period]
(1) No changes in asthma treatment in the past two months
(2) No prior treatment with ICSs, or current use of ICSs at doses basically not exceeding 200 mcg per day (400 mcg per day for budesonide)

[At start of treatment period]
"Partly controlled" or "uncontrolled" as defined by the GINA 2009 guidelines during the last week of observation period
Key exclusion criteria (1) Use of oral, suppository, or intravenous corticosteroids, or long-acting beta 2-agonists (LABAs) for asthma within the past two months
(2) Smoking history within the past six months
(3) Any other concomitant pulmonary diseases, including COPD, bronchiectasis, lung cancer, collagen disease, pulmonary hypertension, late effects of tuberculosis, and diffuse panbronchiolitis
(4) Contraindication to the study drug
(5) Any other conditions which in the judgment of the investigator would make the patient inappropriate for study participation
Target sample size 200

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

Public contact
Name of contact person
1st name
Middle name
Last name Masakazu Ichinose
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address 811-1, Kimiidera, Wakayama
TEL
Homepage URL
Email

Sponsor
Institute ESCORT Study Group
Institute
Department

Funding Source
Organization Japan Allergy Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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 いけだ内科(山口県)
大道内科・呼吸器科クリニック(北海道)
長田病院(福岡県)
久保クリニック(和歌山県)
さそう内科・呼吸器科クリニック(静岡県)
佐野虎ノ門クリニック(東京都)
仙台気道研究所/柴崎内科小児科医院(宮城県)
霧ヶ丘つだ病院(福岡県)
とうだクリニック(大阪府)
鴨池生協クリニック(鹿児島県)
あおばクリニック(埼玉県)
日本大学医学部付属病院(東京都)
広島アレルギー呼吸器クリニック(広島県)
宮武内科(大阪府)
湯川内科クリニック(栃木県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 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
2010 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 27 Day
Last modified on
2011 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005346

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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