UMIN-CTR Clinical Trial

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

bronchial asthma

Classification by specialty

Pneumology

Clinical immunology

Classification by malignancy

Others

Genomic information

NO

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

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

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

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

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

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

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

Institute

ESCORT Study Group

Institute

Department

Personal name

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

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

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）

Date of disclosure of the study information

2010

Year

11

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

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 related 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