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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002390
Receipt No. 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

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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
Email 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
Email tomookot@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002936

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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