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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011241
Receipt No. 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

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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
Last 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
1st 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
Institute Hiroshima Allergy and Respiratory Clinic
Institute
Department

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
URL(English) https://upload.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


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