UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013081
Receipt number R000015261
Scientific Title Plasma connective tissue growth factor (CTGF) as a surrogate biomarker in asthma.
Date of disclosure of the study information 2014/02/05
Last modified on 2014/02/05 15:53:32

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Basic information

Public title

Plasma connective tissue growth factor (CTGF) as a surrogate biomarker in asthma.

Acronym

Plasma CTGF in asthma.

Scientific Title

Plasma connective tissue growth factor (CTGF) as a surrogate biomarker in asthma.

Scientific Title:Acronym

Plasma CTGF in asthma.

Region

Japan


Condition

Condition

asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of the present study is to investigate the utility of plasma CTGF level as a surrogate biomarker in asthma.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlations between plasma CTGF levels and airway obstruction in patients with asthma.

Key secondary outcomes

Correlations between plasma CTGF levels and other clinical parameters in patients with asthma.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Classified as "controlled" under adequate treatment according to the GINA criteria of asthma control

2. Free from asthma symptoms, limitations of activities, exacerbation, and had no more than two rescue treatments a week even when required.

3. Received ICS, the mainstay of anti-inflammatory therapy in asthma, or ICS plus other antiasthmatic drugs for 1 year or more, with no change in dose within the previous 8 weeks.

Key exclusion criteria

1) treatment with oral or intravenous corticosteroids in the previous 4 weeks,

2) having a smoking history more than 10 pack-years,

3) having other pulmonary diseases including chronic obstructive pulmonary disease.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takafumi Suda

Organization

Hamamatsu University School of Medicine

Division name

Second division, Department of Internal Medicine

Zip code


Address

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

TEL

053-435-2261

Email

suda@hama-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoyuki Fujisawa

Organization

Hamamatsu University School of Medicine

Division name

Second division, Department of Internal Medicine

Zip code


Address

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

TEL

053-435-2261

Homepage URL


Email

fujisawa@hama-med.ac.jp


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

2014 Year 02 Month 05 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

Plasma CTGF levels were higher in patients with asthma than healthy volunteers. Plasma CTGF levels showed significantly negative correlations with forced expiratory volume in 1 second (FEV1), FEV1 percentage of the predicted value (%pred), forced expiratory flow at 50% of the forced vital capacity (FEF50), FEF50 %pred, FEF75, and FEF75 %pred, parameters reflecting the degree of airway obstruction, in patients with asthma.

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

2009 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 03 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

Plasma CTGF levels negatively correlated with the Asthma Control Test scores, patient-based index of clinical control of asthma.


Management information

Registered date

2014 Year 02 Month 05 Day

Last modified on

2014 Year 02 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015261


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name