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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000015602
Receipt No. R000018129
Scientific Title Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Date of disclosure of the study information 2014/11/04
Last modified on 2015/11/21

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Basic information
Public title Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Acronym Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Scientific Title Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Scientific Title:Acronym Evaluation of the clinical efficacy and safety of fluticasone propionate/ formoterol fumarate combination (FFC) for the treatment of bronchial asthma-with and without use of an inhalation device
Region
Japan

Condition
Condition Bronchial Asthma
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of FFC with and without use AeroChamber Plus on lung function
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FEV1
Key secondary outcomes Lung function Score
Asthma Control Questionnaire
FeNO
Impulse Oscillation System

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Inhalation of FFC without AeroChamber Plus--> With AeroChamber Plus
Interventions/Control_2 Inhalation of FFC with AeroChamber Plus--> Without AeroChamber Plus
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 1) Outpatient >=20 years old
2) Patients who were diagnosed with asthma and need ICS and LABA by the investigator.
3) Patients with %FEV1 more than 60% at visit1
4) Documented agreement with full explanation of the study to the participant.
Key exclusion criteria 1) Patients with any serious cardiac, hepatic, renal, hematological disorder, or any other serious complication
2) Patients who have coexisting malignant tumor or a history of malignant tumor
3) Patients who have history of smoking within the past 1 year
4) Patients who are pregnant, lactating, possibly pregnant, or those who desire to become pregnant during their participation in the study
5) Others deemed unsuitable by the investigator
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuji Tohda
Organization Kinki University
Division name Department of respiratory medicine and allergology
Zip code
Address 377, Ohnohigashi Osakasayama-city,Osaka, Japan
TEL 072-366-0221
Email tohda@med.kindai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yuji Tohda
Organization Kinki University
Division name Department of respiratory medicine and allergology
Zip code
Address 377, Ohnohigashi Osakasayama-city,Osaka, Japan
TEL 072-366-0221
Homepage URL
Email tohda@med.kindai.ac.jp

Sponsor
Institute Kinki university Department of respiratory medicine and allergology
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
2014 Year 11 Month 04 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 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
2014 Year 11 Month 04 Day
Last modified on
2015 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018129

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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