UMIN-CTR Clinical Trial

Public title

The effects of budesonide/formoterol maintenance and reliever therapy on airway inflammation in asthma patients; open label, randomized parallel group comparison study with fluticasone/salmeterol

Acronym

The effects of SMART on airway inflammation in asthma patients

Scientific Title

The effects of budesonide/formoterol maintenance and reliever therapy on airway inflammation in asthma patients; open label, randomized parallel group comparison study with fluticasone/salmeterol

Scientific Title:Acronym

The effects of SMART on airway inflammation in asthma patients

Region

Japan

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To compare the effects of budesonide/formoterol maintenance and reliever therapy and salmeterol/fluticasone on airway inflammation

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in exhaled nitric oxide concentration from before to after 8 weeks treatment

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

SMART group
Budesonide / formoterol 160/4.5 µg two inhalations bid (morning and evening) + budesonide / formoterol 160/4.5 µg one inhalation for asthma symptom as a reliever

Interventions/Control_2

SFC group
Salmeterol / fluticasone 50/250 µg one inhalation bid + procaterol 20 µg inhalation for asthma symptom as a reliever

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

- Signed informed consent by the patient
- Outpatient, man or woman, 20 years or older
- Diagnosis of asthma
- Baseline ACQ score > 0.75
- Baseline FeNO > 35 ppb
- Prescribed daily use of an Inhaled Corticosteroids (ICS) for more than 12 weeks prior to the enrollment. The doses of ICS had to be 400 - 800 mcg/day of budesonide or corresponding dose of ICS
- Two to six occasional use of reliever medicine per week prior to the enrollment
- IOS parameters for the small airway (R5-R20) > 0.05 kPa/L/s

Key exclusion criteria

- Patients with a history of hypersensitivity (including contact dermatitis) to any ingredient contained in the study drugs
- Patients with infections with no available effective antimicrobial drugs or with deep seated mycosis
- Patients with tuberculosis
- Patients with rhinitis needed to be treated clinically
- Respiratory infection, judged by the investigator as an infection affecting the asthma, within 8 weeks prior to enrollment
- Use of any beta-blocking agents (including eye-drops)
- Treatment with oral, parenteral or rectal steroids within 30 days prior to enrollment
- Any significant disease or disorder judged by the investigator
- Current or previous with a smoking history,10 pack years or more, or smoking cessation no longer than 6 months prior to enrollment
- Pregnancy, breast-feeding or planned pregnancy during the study
- Suspected poor capability, as judged by the investigator

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Soichiro Hozawa

Organization

Hiroshima Allergy and Respiratory Clinic

Division name

Department of respiratory medicine

Zip code

Address

Daiichi-Teraoka building 6F, 1-9-28, Hikari-maci, Higashi-ku, Hiroshima city, Hiroshima, 732-0052, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Hiroshima Allergy and Respiratory Clinic

Division name

Department of respiratory medicine

Zip code

Address

TEL

082-568-1167

Homepage URL

Email

allsea30@ms1.megaegg.ne.jp

Institute

Hiroshima Allergy and Respiratory Clinic

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2013

Year

07

Month

21

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

2012

Year

06

Month

27

Day

Date of IRB

Anticipated trial start date

2012

Year

07

Month

01

Day

Last follow-up date

2013

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

21

Day

Last modified on

2013

Year

07

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013172