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
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
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
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
