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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000627
Receipt No. R000000759
Scientific Title Open-label, single-center, randomized and parallel-group study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in patients with cough variant asthma.
Date of disclosure of the study information 2007/03/01
Last modified on 2008/09/04

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Basic information
Public title Open-label, single-center, randomized and parallel-group study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in patients with cough variant asthma.
Acronym Controlled study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in cough variant asthma
Scientific Title Open-label, single-center, randomized and parallel-group study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in patients with cough variant asthma.
Scientific Title:Acronym Controlled study to compare the effect of inhaled corticosteroids and leukotriene receptor antagonists in cough variant asthma
Region
Japan

Condition
Condition Cough variant asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of short course treatment with high dose budesonide (BUD), low dose BUD and montelukast in patients with newly diagnosed cough variant asthma, in terms of symptoms, bronchial responsiveness, cough sensitivity, airway inflammation assessed by sputum and prognosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Coughing symptom
Key secondary outcomes 1 Symptom
2 Capsaicin cough sensitivity
3 Methacholine airway responsiveness
4 Pulmonary function test
5 Inflammatory biomarker of induced sputum and peripheral blood
6 Safety
7 Progression to classical asthma

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 NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 High dose budesonide
600mcg bid
3 months
Interventions/Control_2 Low dose budesonide
200mcg bid
3 months
Interventions/Control_3 Montelukast
10mg once a day
3 months
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

Not applicable
Gender Male and Female
Key inclusion criteria 1 Chronic cough persisting for longer than 8 weeks without wheezing or dyspnea
2 No other concomitant respiratory disease within 8 weeks
3 Presence of airway hyperrespon- siveness
4 Symptomatic response of coughing to bronchodilators
5 Normal chest radiograph
Key exclusion criteria 1 Current smoker
2 Past treatment with inhaled corticosteroids or leukotriene receptor antagonists
3 Receiving oral corticosteroids in the previous 2 months
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Niimi
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo- ku, Kyoto
TEL 075-751-3830
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Yamaguchi
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo- ku, Kyoto
TEL 075-751-3830
Homepage URL
Email

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

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

Other administrative information
Date of disclosure of the study information
2007 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2006 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 01 Day
Last modified on
2008 Year 09 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000759

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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