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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004383
Receipt No. 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

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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
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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