UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008394
Receipt number R000009868
Scientific Title Effects of adding budesonide/formoterol in patients with COPD
Date of disclosure of the study information 2012/07/10
Last modified on 2013/02/09 15:28:42

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Basic information

Public title

Effects of adding budesonide/formoterol in patients with COPD

Acronym

Effects of budesonide/formoterol

Scientific Title

Effects of adding budesonide/formoterol in patients with COPD

Scientific Title:Acronym

Effects of budesonide/formoterol

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease (COPD)

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To estimate changes of pulmonary function adding budesonide/formoterol in COPD patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Pulmonary function test

Key secondary outcomes

Imaging
St. George's Respiratory Questionnaire (SGRQ)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Inhaled budesonide/formoterol for 12 weeks

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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with chronic obstructive pulmonary disease (COPD)
Patients can use the inhaled therapy
Patients gave written informed consent

Key exclusion criteria

History of hyper-sensitivity to budesonide/formoterol
Patients with bronchial asthma
Patients during acute exacerbation
Presence of infectious disease, pneumothorax, and severe heart failure

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kingo Chida

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal medicine

Zip code


Address

1-20-1, Handayama, Hamamatsu, Shizuoka, 431-3192, Japan

TEL

053-435-2263

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hideki Yasui

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal medicine

Zip code


Address


TEL

053-435-2263

Homepage URL


Email



Sponsor or person

Institute

Hamamatsu University School of Medicine

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


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



Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.sciencedirect.com/science/article/pii/S1094553913000515

Number of participants that the trial has enrolled


Results

MDCT demonstrated budesonide/formoterol induced bronchodilation in the non-small airway. CT imaging can evaluate drug therapeutic effect and may provide additional insights into pharmacotherapy for COPD.

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 12 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 12 Month 01 Day

Last follow-up date

2013 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete

2012 Year 08 Month 20 Day

Date analysis concluded

2012 Year 12 Month 20 Day


Other

Other related information



Management information

Registered date

2012 Year 07 Month 09 Day

Last modified on

2013 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009868


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name