UMIN-CTR Clinical Trial

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

bronchial asthma

Classification by specialty

Pneumology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

Institute

IAA Study Group

Institute

Department

Personal name

Organization

The Waksman Foundation of Japan INC.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2011

Year

04

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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