UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005406 |
|---|---|
| Receipt number | R000006417 |
| Scientific Title | Exploratory study of test indices applicable to decisions regarding changes to treatment steps in adult patients with bronchial asthma |
| Date of disclosure of the study information | 2011/04/08 |
| Last modified on | 2012/10/09 20:37:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory study of test indices applicable to decisions regarding changes to treatment steps in adult patients with bronchial asthma
Acronym
Exploratory study of test indices applicable to decisions regarding changes to treatment steps in adult patients with bronchial asthma
Scientific Title
Exploratory study of test indices applicable to decisions regarding changes to treatment steps in adult patients with bronchial asthma
Scientific Title:Acronym
Exploratory study of test indices applicable to decisions regarding changes to treatment steps in adult patients with bronchial asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe prospectively the changes in various markers following a dose reduction in budesonide/formoterol combination drug (Symbicort Turbuhaler) in patients with bronchial asthma who received treatment with budesonide/formoterol (4 inhalations/day) for at least 3 months and whose symptoms during this period were controlled according to the GINA classification.
Basic objectives2
Others
Basic objectives -Others
Using sputum eosinophil count as the standard marker of airway inflammation, to screen easy-to-measure biomarkers whose levels change in parallel to those of the standard marker and to identify biomarkers which can predict, prior to a dose reduction, those patients whose airway inflammation is likely to be aggravated by the change.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Patients are classified into those who show aggravation of airway inflammation and those who do not after a dose reduction. A multivariate analysis is performed to identify the factors and parameters which account for the aggravation and increased eosinophil ratio (reflecting aggravation of airway inflammation) by evaluating patient demography prior to the dose reduction, absolute values of various parameters determined, and combinations thereof.
2) The correlation of sputum eosinophil count with FeNO level, ACQ score or GINA classification in asthma control is investigated.
Key secondary outcomes
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
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Budesonide/Formoterol 160/4.5 mcg, one inhalation, twice daily
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
1. Patients with bronchial asthma who are at least 18 years of age at the time of consent
2. Patients who are able to understand the details of the study and who, at their own will, give written consent to participate in the study.
3. Patients, who in the opinion of the investigator, can comply with adherence to treatment, keep a patient diary, and perform peak flow measurements (morning and night) during the study period.
4. Patients who have continuously received given budesonide/formoterol (4 inhalations/day; BUD/FOR 640/18 mcg/day) therapy for at least the preceding 3 months
5. Patients with controlled asthma, as defined by the GINA classification, for at least the preceding 3 months. It should be noted that the control level at the commencement of the observation period may be assessed subjectively by the investigator as materials such as the patient diary may not always be available. In this study, the normal range for respiratory function was defined as any of the following:
1) %FEV1 >= 80%
2) FEV1 is >= 80% of personal best
3) Morning PEF is >= 80% of normal predicted value (in 1 week)
4) Morning PEF is >= 80% of personal best (in 1 week)
6. Patients whose ACQ5 score (survey regarding asthma management) is <= 0.75
Key exclusion criteria
1. Smoking history: >= 10 packs/yr
2. Current smokers (including patients who quit smoking < 1mth)
3. Patients with any of the following lung diseases:
COPD, bronchiectasis, lung cancer, collagen disease, pulmonary hypertension, tuberculosis sequelae, diffuse panbronchiolitis, interstitial pneumonia
4. Patients who were hospitalized due to asthma in the past year, who had an emergency presentation of asthma in the past 3 months, or who received an infusion of steroids due to worsening of asthma in the past 3 months.
5.Other patients judged by the physician to be inappropriate for this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kume |
Organization
Kinki University Faculty of Medicine
Division name
Department of Respiratory Medicine and Allergology
Zip code
Address
377-2, Ohnohigashi, Osakasayama, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Kume |
Organization
Kinki University Faculty of Medicine
Division name
Department of Respiratory Medicine and Allergology
Zip code
Address
377-2, Ohnohigashi, Osakasayama, Osaka
TEL
Homepage URL
Sponsor or person
Institute
IAA Study Group
Institute
Department
Personal name
Funding Source
Organization
The Waksman Foundation of Japan INC.
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
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（大阪府）
帝京大学（東京都）
慶應義塾大学（東京都）
鹿児島大学（鹿児島県）
久留米大学（福岡県）
福島県立医科大学（福島県）
静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 08 | 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 | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | 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
| 2011 | Year | 04 | Month | 08 | Day |
Last modified on
| 2012 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006417
