UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003174
Receipt number R000003419
Scientific Title The effects of inhaled procaterol on COPD patients.
Date of disclosure of the study information 2010/02/12
Last modified on 2011/08/17 11:12:22

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Basic information

Public title

The effects of inhaled procaterol on COPD patients.

Acronym

The effects of inhaled procaterol on COPD patients.

Scientific Title

The effects of inhaled procaterol on COPD patients.

Scientific Title:Acronym

The effects of inhaled procaterol on COPD patients.

Region

Japan


Condition

Condition

Chronic obstructive pulmonary disease (COPD)

Classification by specialty

Medicine in general Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To find the clinical parameters which associtate with the effectiveness of inhaled procaterol in COPD patitents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The collerations between clinical and functional parameters and the effects procaterol inhalation on lung function, dyapnea and exercise performance (6MW) in patients with COPD .

Key secondary outcomes

Adverse event


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Inhalation of procaterol

Interventions/Control_2

Inhalation of placebo.

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

30 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Able and willing to read, understand, and provide written Informed Consent;
2.Age range of 30-80 years;
FEV1%<70% after bronchodilator inhalation
Diagnosed as COPD
%FEV1<80%
MRC dyspnea grade >=1
Chest CT within 6 months

Key exclusion criteria

History of exacerbation in the previous 8 weeks
Co-morbid conditions (heart diseases or neuromuscular diseases) limiting exercise.
The other significant conditions that seem to limit study protocol.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masamichi Mineshita

Organization

St.Marianna University School of Medicine

Division name

Respiratory and Infectious Diseases

Zip code


Address

2-16-1Sugao, Miyamae-ku, Kawasaki-City, Kanagawa

TEL

044-977-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masamichi Mineshita

Organization

St.Marianna University School of Medicine

Division name

Respiratory and Infectious Diseases

Zip code


Address

2-16-1Sugao, Miyamae-ku, Kawasaki-City, Kanagawa

TEL


Homepage URL


Email



Sponsor or person

Institute

St.Marianna University School of Medicine
Respiratory and Infectious Diseases

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

2010 Year 02 Month 12 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

Completed

Date of protocol fixation

2010 Year 01 Month 12 Day

Date of IRB


Anticipated trial start date

2010 Year 02 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

2010 Year 02 Month 12 Day

Last modified on

2011 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003419


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name