UMIN-CTR Clinical Trial

Public title

Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS

Acronym

Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS (EVOLUTION study)

Scientific Title

Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS

Scientific Title:Acronym

Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS (EVOLUTION study)

Region

Japan

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the efficacy and safety of ICS/LABA combination therapy in patients with bronchial asthma untreated with inhaled corticosteroid (ICS) and long-acting inhaled beta 2 agonist (LABA).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Achievement rate of "well-control" as defined by JGL2009 at 8 weeks after start of treatment period

Key secondary outcomes

(1)Efficacy endpoints
- Achievement rate of "well-control" as defined by JGL2009 at 2 weeks after start of treatment period
- Achievement rate of "well-control" as defined by GINA2006 at 2 and 8 weeks after start of treatment period
- Daytime asthmatic symptoms
- Nocturnal asthmatic symptoms and arousal
- Limitation of activities
- Frequency of use of short-acting inhaled beta 2 agonist (SABA)
- %FEV1.0
- ACQ5
- Adherence
- NO in breath
- PEF
(2) Safety endpoints
- Adverse events
- Adverse drug reactions

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Symbicort group
Two inhalations of Symbicort Turbuhaler 60, twice daily
Treatment period (8 weeks)

Interventions/Control_2

Pulmicort group
Two inhalations of Pulmicort 200g Turbuhaler 56 (or 112), twice daily
Treatment period (8 weeks)

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

[At start of observation period]
1) Patients who have not used ICS within 3 months before start of observation period
2) Patients who have not used LABA within 1 week before start of observation period
3) Patients presenting with "cough," "wheezing," "dyspnea," or any other symptom that suggests asthma, or those who are diagnosed with asthma by the investigator
4) Nonsmokers and patients who have not smoked for 1 year or longer (if patients have not smoked for 1 year or longer, those with a smoking history of 10 pack-year or more will not be included)
5) Patients aged 20 years or over at the time of informed consent
6) Patients who understand the content of the study and give written consent to participation in the study at their own will
[At start of treatment period]
The following inclusion criteria will be confirmed before start of treatment period:
1) Subjects diagnosed with asthma by the investigator during observation period
2) Subjects presenting with asthmatic symptoms once or more a week during observation period

Key exclusion criteria

[At start of observation period]
1) Patients with frequent nocturnal symptoms
2) Patients with limited daily activities
3) Patients who are judged to require oral steroid therapy to control asthmatic symptoms at start of observation period
4) Patients with %FEV1.0 less than 60% at start of period
5) Patients who have used steroid therapy (injection, oral preparation, intestinal infusion, or suppository) within 4 weeks before start of period
6) Patients who have started treatment with any leukotriene receptor antagonist within 2 months before start of period
7) Patients who have any coexisting respiratory infection including tuberculosis or acute upper respiratory tract inflammation/bronchitis, or those who have a history of such infections within 4 weeks before start of period
8) Patients who have any coexisting respiratory disease (COPD, pulmonary fibrosis, etc.) other than asthma
9) Patients with any serious cardiac, hepatic, renal, hematological disorder, or any other serious complication
10) Patients who have coexisting malignant tumor or a history of malignant tumor
11) Patients who have started new hyposensitization or nonspecific therapy within 3 months before start of period
12) Patients who are pregnant, lactating, possibly pregnant, or those who desire to become pregnant during their participation in the study
13) Others deemed unsuitable by the investigator
14) Patients who meet any of the contraindications described in the package insert of the study drug
[At start of observation period]
1) Subjects with a body temperature of 37.5 degrees or above that suggests acute upper respiratory tract inflammation/bronchitis during observation period
2) Subjects who have used new asthma therapy other than the pretreatment drug during observation period
3) Subjects who have used steroid therapy (injection, oral preparation, inhalation, intestinal infusion, or suppository) during observation period
4) Others deemed unsuitable by the investigator

Target sample size

280

Name of lead principal investigator

1st name
Middle name
Last name	Akio Niimi

Organization

Graduate School of Medicine, Kyoto University

Division name

Department of Respiratory Medicine (Internal Medicine)

Zip code

Address

53, Shogoin-Kawaramachi, Sakyo-ku, Kyoto

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

IAA Study Group

Division name

ICS/LABA Combination Therapy Intervention Study Group

Zip code

Address

53, Shogoin-Kawaramachi, Sakyo-ku, Kyoto

TEL

075-751-3830

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

Date of disclosure of the study information

2010

Year

06

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

Open public recruiting

Date of protocol fixation

2010

Year

03

Month

29

Day

Date of IRB

Anticipated trial start date

2010

Year

06

Month

01

Day

Last follow-up date

2011

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

06

Month

08

Day

Last modified on

2010

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004503