UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011241
Receipt number R000013172
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
Date of disclosure of the study information 2013/07/21
Last modified on 2013/07/21 19:18:18

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Basic information

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

Condition

Bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

Primary outcomes

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

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



Eligibility

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


Research contact person

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



Public contact

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


Sponsor or person

Institute

Hiroshima Allergy and Respiratory Clinic

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 21 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name