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

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 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


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

Value
https://center6.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