UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009599 |
|---|---|
| Receipt number | R000011259 |
| Scientific Title | Effect of adjusting the combination of budesonide/formoterol on asthma management for 24 weeks |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2018/06/26 11:22:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of adjusting the combination of budesonide/formoterol on asthma management for 24 weeks
Acronym
Effect of ICS/LABA on asthma management
Scientific Title
Effect of adjusting the combination of budesonide/formoterol on asthma management for 24 weeks
Scientific Title:Acronym
Effect of ICS/LABA on asthma management
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We analyzed the relationship between asthma symptoms, including peak expiratory flow rate (PEFR) and adjustment of the dose by the patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
asthmatic symptpms and peak expiratory flow rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Patients with asthma who are stable at least last 4 weeks.
Key exclusion criteria
Patients who need the corticosteroid excepting the inhale corticosteroid.
Patients with other respiratory diseases, malignant diseases, pregnancy and/or lactation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Fukuda |
Organization
Dokkyo Medical University
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL
0282-86-1111
t-fukuda@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | syomuka |
Organization
Dokkyo Medical University
Division name
The ethics committee
Zip code
Address
880 Kita-kobayashi, Mibu, Tochigi, 321-0293, Japan
TEL
0282-86-1111
Homepage URL
syomuka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
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
| 2012 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://asthmarp.biomedcentral.com/articles/10.1186/s40733-018-0043-8
Number of participants that the trial has enrolled
Results
Background
The combination of budesonide + formoterol (BFC) offers the advantages of dose adjustment in a single inhaler according to asthma symptoms. We analyzed the relationship between asthma symptoms in terms of peak expiratory flow (PEF) and dose adjustment by the patient.
Methods
Twenty-eight patients with asthma who used BFC for alleviation of their symptoms (12 men, 16 women; 60 years old) were instructed that the inhaled BFC dose could be increased to a maximum of 8 inhalations per day according to symptom severity. Patients measured and recorded PEF every morning and evening in their asthma diary along with their symptoms and the dose of drugs taken.
Results
Sixteen of the 28 patients increased their dose for asthma symptoms. The time to recovery from the asthma symptoms was significantly shorter when cough was the only symptom present compared with dyspnea or wheeze (1.4 vs. 5.3 or 6.6 days, p？<？0.05) and when they had only one symptom compared with two or three symptoms (1.3 vs. 5.7 or 10.5, p？<？0.01). The relationship between PEF (% of personal best) when the dose was increased (Y) and the days for the increased dose to achieve a PEF greater than PEF in the symptom-free state (X) was determined to be Y？=？-0.591X？+？89.2 (r2？=？0.299, p？<？0.001).
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
| 2011 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
As a guide for increasing the BFC dose when patients with mild asthma have asthma symptoms, the dose should be increased when cough is present or PEF is decreased to 88.9% (i.e., X？=？0.5).
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011259
