UMIN-CTR Clinical Trial

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

COPD with asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Jikei University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Jikei Univerisity Hospital

Date of disclosure of the study information

2011

Year

03

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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