UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009990 |
|---|---|
| Receipt number | R000011695 |
| Scientific Title | Comparison of Clinical Effects of Salmeterol/Fluticasone Propionate Combination Products Delivered via Metered-Dose Inhaler with Dry Powder Inhaler in Patients with Moderate Asthma |
| Date of disclosure of the study information | 2013/02/08 |
| Last modified on | 2014/08/13 19:57:06 |
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Basic information
Public title
Comparison of Clinical Effects of Salmeterol/Fluticasone Propionate Combination Products Delivered via Metered-Dose Inhaler with Dry Powder Inhaler in Patients with Moderate Asthma
Acronym
SFC Diskus vs aerosol inhaler
Scientific Title
Comparison of Clinical Effects of Salmeterol/Fluticasone Propionate Combination Products Delivered via Metered-Dose Inhaler with Dry Powder Inhaler in Patients with Moderate Asthma
Scientific Title:Acronym
SFC Diskus vs aerosol inhaler
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the clinical effects of SFC dry powder products (Diskus) and those of aerosol products in the viewpoint of peripheral airway inflammation in adult asthmatic patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Respiratory resistance and reactance measured by Forced Oscillation Technique (Most Graph)
Key secondary outcomes
FeNO
Asthma Control Test score
Side effect
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SFC Diskus; wash out; SFC aerosol
Interventions/Control_2
SFC aerosol; wash out; SFC Diskus
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The moderate persistent adult asthmatics who had received ICS or ICS/LABA combination inhaler of fluticasone 500 micro-g equivalent daily or less and under well-control status have been recruited.
Key exclusion criteria
Current smokers, those who had pulmonary diseases with non reversible airflow obstruction such as COPD or pulmonary fibrosis were excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Hojo |
Organization
National Center for Global Health and Medicine
Division name
Devision of Respiratory Medicine
Zip code
Address
Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
TEL
03-3202-7181
mhojo@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nahoko Sato |
Organization
National Center for Global Health and Medicine
Division name
Devision of Respiratory Medicine
Zip code
Address
Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
TEL
03-3202-7181
Homepage URL
nahoko.t.k.d@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 08 | 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
| 2013 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 27 | Day |
Date trial data considered complete
| 2013 | Year | 07 | Month | 27 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 07 | Day |
Last modified on
| 2014 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011695
