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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028902
Receipt No. 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

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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
Institute Kamei Internal medicine and Respiratory clinic
Institute
Department

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
URL(English) https://upload.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


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