UMIN-CTR Clinical Trial

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

Bronchial asthma

Classification by specialty

Pneumology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Sakai Hospital, Kinki University School of Medicine

Institute

Department

Personal name

Organization

Japan Allergy Foundation

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）

Date of disclosure of the study information

2011

Year

08

Month

01

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

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 related information

Registered date

2011

Year

07

Month

27

Day

Last modified on

2012

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007167