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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005204
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Jikei University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006182

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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