UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004383
Receipt number R000005240
Scientific Title Efficacy and safety of a four-week treatment with budesonide/formoterol in patients with cough variant asthma: Open-label, randomized and parallel-group study compared with budesonide.
Date of disclosure of the study information 2010/10/14
Last modified on 2013/04/08 23:47:50

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Basic information

Public title

Efficacy and safety of a four-week treatment with budesonide/formoterol in patients with cough variant asthma: Open-label, randomized and parallel-group study compared with budesonide.

Acronym

Controlled study to compare the effect of budesonide/formoterol and budesonide in cough variant asthma.

Scientific Title

Efficacy and safety of a four-week treatment with budesonide/formoterol in patients with cough variant asthma: Open-label, randomized and parallel-group study compared with budesonide.

Scientific Title:Acronym

Controlled study to compare the effect of budesonide/formoterol and budesonide 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 budesonide/formoterol and budesonide in patients with newly diagnosed cough variant asthma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Leicester Cough Questionnaire (LCQ) score

Key secondary outcomes

1. Exhaled nitric oxide concentrations
2. Indices of pulmonary function
3. Biomarkers of blood
4. Visual analogue scale score of cough
5. clinical symptoms


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

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

budesonide/formoterol combination 160/4.5 mcg, two inhalation, twice a day

Interventions/Control_2

budesonide 200 mcg, two inhalation, twice a day

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Cough variant asthma patients
2. Patients who have cough symptom
3. Patients who gave consent to the study

Key exclusion criteria

1. Patients with hypersensitivity to Budesonide/formoterol.
2. Patients with other respiratory diseases.
3. Patients who take inhaled corticosteroids in the last 4 weeks
4. Patients who take long acting beta agonists in the last 5 days
5. Patients who take antiallergy agents and inhaled anticholinergic in the last 2 weeks
6. Patients who are given systemic corticosteroids in the last 30 days
7. Current smoker or ex-smoker of > 10 pack-years
8. Pregnancy or lactation
9. Patients who are considered inappropriate by physicians in charge

Target sample size

80


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 Kawahara-cho, Shogoin, Sakyo- ku, Kyoto

TEL

075-751-3830

Email



Public contact

Name of contact person

1st name
Middle name
Last name Toshiyuki Iwata

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

1. Kitano Hospital
2. Osaka Saiseikai Nakatsu Hospital
3. Kobe City Medical Center General Hospital
4. Shinko Hospital

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

2010 Year 10 Month 14 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

Completed

Date of protocol fixation

2010 Year 08 Month 31 Day

Date of IRB


Anticipated trial start date

2011 Year 02 Month 01 Day

Last follow-up date

2013 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 10 Month 14 Day

Last modified on

2013 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name