UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000627
Receipt number 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 17:04:42

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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 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



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

Value
https://center6.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