UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002390 |
|---|---|
| Receipt number | R000002936 |
| Scientific Title | Study to examine the effects of Salmeterol/fluticasone propionate combination(SFC) in patients with cough variant asthma(CVA) |
| Date of disclosure of the study information | 2009/08/26 |
| Last modified on | 2014/03/31 03:54:02 |
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Basic information
Public title
Study to examine the effects of Salmeterol/fluticasone propionate combination(SFC) in patients with cough variant asthma(CVA)
Acronym
Study to examine the effects of SFC in CVA
Scientific Title
Study to examine the effects of Salmeterol/fluticasone propionate combination(SFC) in patients with cough variant asthma(CVA)
Scientific Title:Acronym
Study to examine the effects of SFC in CVA
Region
| Japan |
Condition
Condition
Cough variant asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine clinical effects of Salmeterol/fluticasone propionate combination in cough variant asthma patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Visual analogue scale score of cough
Key secondary outcomes
1)Parameters of impulse oscillometry
2)Indices of pulmonary function
3)Indices of Capsicine cough sensitivity
4)Exhaled nitric oxide concentrations
5)Biomarker levels of induced sputum
6)Biomarker levels of serum and urine
7)Scores of questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inhale Salmeterol/fluticasone propionate combination 250 mcg twice daily
Interventions/Control_2
Inhale Fluticasone propionate 200 mcg twice daily, and take Montelukast 10 mg once daily
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
1)Couth variant asthma patients
2)Patients who are still poorly controlled despite monotherapy with inhaled corticosteroids
3)Patients who gave consent to the study
Key exclusion criteria
1)Patients without cough symptom in the last 1 week before enrollment
2)Patients with other respiratory diseases
3)Patients taking Long acting be-ta 2 agonist(LABA) or Leukotriene receptor antagonist(LTRA)
4)Patients who are given systemic corticosteroid in the last 4 weeks
5)Patients who suffered from upper respiratory infection in the last 4 weeks
6)Patients who had smoked in the last 6 months, or who had smoked more than 10 pack year in the past
7)Patients who are considered inappropriate by physicians in charge
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisako Matsumoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
hmatsumo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoko Tajiri |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
Homepage URL
tomookot@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 04 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 26 | Day |
Last modified on
| 2014 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002936
