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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015512
Receipt No. 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

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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
Institute Graduate School of Medical Sciences, Nagoya City University
Institute
Department

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
URL(English) https://upload.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


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