UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004465 |
|---|---|
| Receipt number | 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 09:16:58 |
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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
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
Sponsor or person
Institute
ESCORT Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005346
