UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.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

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