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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020229
Receipt No. R000023356
Scientific Title Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma
Date of disclosure of the study information 2015/12/21
Last modified on 2015/12/24

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Basic information
Public title Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma
Acronym Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma
Scientific Title Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma
Scientific Title:Acronym Efficacy of switching ICS to salmeterol/fluticasone combination aerosol in patients with adult bronchial asthma
Region
Japan

Condition
Condition bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the change in asthma control obtained by switching from an ICS to a salmeterol/fluticasone combination (SFC) aerosol.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the PEF measured in the outpatient department and the ACT during 12 weeks
Key secondary outcomes the information obtained from a questionnaire given to the patients and medication adherence.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients switched from their previous treatment with ICS to SFC, which contained the same amount of ICS. We evaluated the peak expiratory flow (PEF), ACT, and dose counter during a 12-week period.
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

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The inclusion criteria were (i) patients who had been using ICS and LABA separately (ii) patients who had been using only ICS and who had an Asthma Control Test (ACT) score < 20.
Key exclusion criteria severe infection, deep fungal infection, active infection, history of drug allergy to SFC, investigator judged as inappropriate for this study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kotaro Kajiwara
Organization Matsuyama Red Cross Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1 Bunkyocho, Matsuyama-shi, Ehime, Japan
TEL +81899241111
Email k-kajiwara@matsuyama.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kotaro Kajiwara
Organization Matsuyama-Red-Cross-Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1 Bunkyocho, Matsuyama-shi, Ehime, Japan
TEL +81899241111
Homepage URL
Email k-kajiwara@matsuyama.jrc.or.jp

Sponsor
Institute Matsuyama-Red-Cross-Hospital
Institute
Department

Funding Source
Organization Matsuyama-Red-Cross-Hospital
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
2015 Year 12 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

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
2014 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 16 Day
Last modified on
2015 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023356

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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