UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005204 |
|---|---|
| Receipt number | R000006182 |
| Scientific Title | A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators |
| Date of disclosure of the study information | 2011/03/06 |
| Last modified on | 2011/03/06 21:46:22 |
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Basic information
Public title
A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators
Acronym
A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators
Scientific Title
A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators
Scientific Title:Acronym
A randomized, comparative study of Budesonide/formoterol versus Fluticasone/Salmeterol in COPD with asthma patients to improve oxidative stress and inflammatory mediators
Region
| Japan |
Condition
Condition
COPD with asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
COPD wit asthma patiens develop inflammatory chnages mainly at the distal airways, and it is suggested that the inflammation causes the elevations of the systemic inflammatory markers and the oxidative stress. The inhalable particle size of Budesonide/formoterol (BUD/FM) is smaller compared with Fluticasone/Salmeterol(FP/SM), so it is assumed that the inhaled particles of BUD/FM can reach the distal airways more effectively and interact with the inflammatory lesions to alleviate it. This randomized, comparative study compares the BUD/FM and FP/SM in COPD with asthma patients to find out which medication can improve the systemic oxidative stress and inflammatory mediators more effectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
improvement in the urine samples of 8-OhdG/Cr and in the blood serum of TNF-a, hs-CRP amounts.
Key secondary outcomes
frequency of asthma attacks, ACT score, improvement in the respiratory functions(FEV1.0 etc), frequency of getting upper tract infections
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
At first, COPD with asthma patients are assinged with FP/SM( Adair) 50ug/250ug 2 BLY per day for 4 weeks as a standard. Then, half patients are assigned randomly to BUD/FM 160/4.5ug 4 puffs per day and the therapy continues for 12 weeks to measure the oxidtive stress and inflammatory markers.
Interventions/Control_2
At first, COPD with asthma patients are assinged with FP/SM( Adair) 50ug/250ug 2 BLY per day for 4 weeks as a standard. Then, half patients are assigned randomly to BUD/FM 160/4.5ug 4 puffs per day and the therapy continues for 12 weeks to measure the oxidtive stress and inflammatory markers.
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. patients who fit the criteria [1] and [2] are defined as COPD with asthma. Criteria [3] and [4] are for reference.
[1] FEV1.0% less than 70% (measurements are done after inhaling 2 puffs of short acting beta-stimulants).
[2] the history of sudden breathing difficulties (especially sudden wheeze or coughing at night or in the morning) that are not caused by labor or infections
[3] history of asthma diagnosis by physicians
[4] elevations of eosinophil in blood serum
Key exclusion criteria
1.patients with other respiratory illness(IPF, ABPA, Chug-Strass syndrome, lung cancer, tuberculosis, bronchiectasis etc)
2.patients with circulatory illness( heart failure etc)
3.past allergic history to ICS
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Hashimoto |
Organization
Jikei University Hospital
Division name
respiratory medicine
Zip code
Address
3-19-18 Nishishinbashi, Minato-ku
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jikei University Hospital
Division name
respiratory medicine
Zip code
Address
3-19-18 Nishishinbashi, Minato-ku
TEL
Homepage URL
Sponsor or person
Institute
Jikei University Hospital
Institute
Department
Personal name
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
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
Jikei Univerisity Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 06 | Day |
Last modified on
| 2011 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006182
