UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015512
Receipt number R000017040
Scientific Title The effect of thromboxane A2 (TXA2) synthase inhibitor (Ozagrel) on difficult to treat chough variant asthma (CVA).
Date of disclosure of the study information 2014/10/23
Last modified on 2016/06/20 17:07:58

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Basic information

Public title

The effect of thromboxane A2 (TXA2) synthase inhibitor (Ozagrel) on difficult to treat chough variant asthma (CVA).

Acronym

The effect of Ozagrel on difficult to treat cough variant asthma.

Scientific Title

The effect of thromboxane A2 (TXA2) synthase inhibitor (Ozagrel) on difficult to treat chough variant asthma (CVA).

Scientific Title:Acronym

The effect of Ozagrel on difficult to treat cough variant asthma.

Region

Japan


Condition

Condition

cough variant asthma

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of thromboxane A2 (TXA2) synthase inhibitor (Ozagrel) add-on therapy to the patients persisting cough in spite of inhaled corticosteroid, long acting bronchodilator, and leukotriene receptor antagonist treatments.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

response of cough symptoms

Key secondary outcomes

1) Improvement of capsaicin cough sensitivity.
2)
Changes of Thromboxane B2 (TXB2)concentration in sputum.

Correlation between changes of TXB2 concentration and
a) Changes of scores in Leister cough questionnaire
b) Improvement of capsaicin cough sensitivity
c) Falling rate of sputum eosinophil count
d) Reduction rate of fractional exhaled nitric oxide and improvement of spirometry , Impulse Oscillation System.
e) Changes of MUC5AC concentration.


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Ozagrel

Interventions/Control_2

histamine H1 receptor antagonist

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cough variant asthma patients 16 years or older who are taking inhaled corticosteroid, long-acting bronchocilator, leukotriene receptor antagonist treatments.

Key exclusion criteria

1. Patients with suspicion of infectious disease such as pulmonary tuberculosis.
2. Current smoker, ex-smoker with smoking history within 6 months, ex-smoker with smoking history more than 5 pack-years.
3. Gastroesophageal reflux disease patients with scores of Frequency Scale for the Symptoms of GERD (FSSG) more than eight.
4. Patients with tendency to hemorrhages.
5.
Patients who takes histamine H1 receptor antagonist, anti-thromboxane agent, angiotensin converting enzyme inhibitor, or Non-Steroidal Anti-Inhlammatory Drugs.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akio Niimi

Organization

Graduate School of Medical Sciences, Nagoya City University

Division name

Respiratory Medicine, Allergy and Clinical Immunology

Zip code


Address

1, kawasumi, mizuho-cho, mizuho-ku, Nagoya-city

TEL

052-851-5511

Email

a.niimi@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takamitsu Asano

Organization

Graduate School of Medical Sciences, Nagoya City University

Division name

Respiratory Medicine, Allergy and Clinical Immunology

Zip code


Address

1, kawasumi, mizuho-cho, mizuho-ku, Nagoya-city

TEL

052-853-8077

Homepage URL


Email

t.asano@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Graduate School of Medical Sciences, Nagoya City University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

名古屋市立大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 23 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

Terminated

Date of protocol fixation

2014 Year 09 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 22 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 10 Month 23 Day

Last modified on

2016 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name