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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009619
Receipt No. R000011286
Scientific Title Treatment effect of switching from salmeterol/fluticasone to formoterol/budesonide combinations in patients with asthma
Date of disclosure of the study information 2012/12/25
Last modified on 2013/06/25

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Basic information
Public title Treatment effect of switching from salmeterol/fluticasone to formoterol/budesonide combinations in patients with asthma
Acronym Comparison of salmeterol/fluticasone with formoterol/budesonide
Scientific Title Treatment effect of switching from salmeterol/fluticasone to formoterol/budesonide combinations in patients with asthma
Scientific Title:Acronym Comparison of salmeterol/fluticasone with formoterol/budesonide
Region
Japan

Condition
Condition Asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the effectiveness of formoterol/budesonide
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes CaNO at week 0 and week 12
Key secondary outcomes J'awNO at week 0 and week 12
FeNO at week 0 and week 12
FEF75 at week 0 and week 12
FEF50 at week 0 and week 12
FVC at week 0 and week 12
Adverse events at week 0 and week 12
Mean rate of all exacerbations at week 0 and week 12

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Switch from salmeterol/fluticasone (Adoair) 50/250 ug one inhalation twice daily to formoterol/budesonide (Symbicort) 4.5/160 ug two inhalation twice daily for 12 weeks
Interventions/Control_2 Continue salmeterol/fluticasone (Adoair) 50/250 ug one inhalation twice daily for 12 weeks
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Salmeterol/budesonide 50/250ug one inhalation twice daily at constant dose for more 2 months
Ability and willingness to provide informed consent
Key exclusion criteria History of hypersensitivity to budesonide and formoterol
History or presence of lung, cardiac, renal and liver desease
Use of systemic corticosteroids
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu-shi,Shizuoka,431-3192 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Taisuke Akamatsu
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu-shi,Shizuoka,431-3192 Japan
TEL
Homepage URL
Email

Sponsor
Institute Hamamatsu University School of Medicine
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 浜松医科大学(静岡県)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 25 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
2012 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 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
2012 Year 12 Month 25 Day
Last modified on
2013 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011286

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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