UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028902
Receipt number R000033074
Scientific Title clinical benefits of twice daily medication of Budesonide and formoterol compared with twice daily medication of budesonide in patients with cough visiting primary care clinic
Date of disclosure of the study information 2017/09/01
Last modified on 2017/08/30 13:02:35

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Basic information

Public title

clinical benefits of twice daily medication of Budesonide and formoterol compared with twice daily medication of budesonide in patients with cough visiting primary care clinic

Acronym

clinical benefits of twice daily medication of Budesonide and formoterol compared with twice daily medication of budesonide in patients with cough visiting primary care clinic

Scientific Title

clinical benefits of twice daily medication of Budesonide and formoterol compared with twice daily medication of budesonide in patients with cough visiting primary care clinic

Scientific Title:Acronym

clinical benefits of twice daily medication of Budesonide and formoterol compared with twice daily medication of budesonide in patients with cough visiting primary care clinic

Region

Japan


Condition

Condition

Cough patients visiting primary clinic

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

clinical benefits of twice daily medication of Budesonide and formoterol compared with twice daily medication of budesonide in patients with cough visiting primary care clinic

Basic objectives2

Others

Basic objectives -Others

Finding indicators in predicting corticosteroid_responsive cough
cough score(cough dairy)
cough intensity(VAS)/LCQ /pulmonary functions/FeNO

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Cough score (4grades by cough diary)

Key secondary outcomes

Cough intensity(VAS)
LCQ
Pulmonary functions(FEV1.0/FVC/%FEV1)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

twice daily medication of Budesonide/formoterol

Interventions/Control_2

twice daily medication of Budesonide

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

dry cough patients continuing beyond 2weeks
Patients without abnormality in the chest X-ray
patients without elevations of CRP or WBC
non-smoker(included ex-smoker)

Key exclusion criteria

atients with clearly suspicions of respiratory or other organs infections
fever experienced within 10days
patients with abnormality in the chest X-ray
patients with elevations of CRP or WBC
patients diagnosed as bronchial asthma or aware of wheezes
patients with abnormal findings in auscultation
patients with purulent sputum
patients with severe nasal symptoms
patients with typical GERD symptoms or diagnosed GERD by upper gastrointestinal endoscopy
current-smoker
patients with chronic pulmonary disease
patients with suspicion of drug induced cough patients prescribed corticosteroids by oral or intravenous or inhalation within 4weeks before entry

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadashi Kamei

Organization

Kamei Internal medicine and Respiratory clinic

Division name

Respiratory

Zip code


Address

3007-4 Ohtashimomati,Takamatsu-city Kagawa Prefecture,Japan

TEL

087-866-5001

Email

t-kamei@mail.netwave.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tadashi Kamei

Organization

Kamei Internal medicine and Respiratory clinic

Division name

Respiratory

Zip code


Address

3007-4 Ohtashimomati,Takamatsu-city Kagawa Prefecture,Japan

TEL

087-866-5001

Homepage URL


Email

t-kamei@mail.netwave.or.jp


Sponsor or person

Institute

Kamei Internal medicine and Respiratory clinic

Institute

Department

Personal name



Funding Source

Organization

None

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

2017 Year 09 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

Completed

Date of protocol fixation

2010 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2012 Year 03 Month 31 Day

Date of closure to data entry

2012 Year 03 Month 31 Day

Date trial data considered complete

2012 Year 04 Month 30 Day

Date analysis concluded

2017 Year 08 Month 30 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 30 Day

Last modified on

2017 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033074


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name