UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002360
Receipt No. R000002898
Scientific Title Efficacy of Montelukast to prolonged cough.
Date of disclosure of the study information 2009/08/21
Last modified on 2017/08/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy of Montelukast to prolonged cough.
Acronym Efficacy of Montelukast to prolonged cough.
Scientific Title Efficacy of Montelukast to prolonged cough.
Scientific Title:Acronym Efficacy of Montelukast to prolonged cough.
Region
Japan

Condition
Condition prolonged cough
Classification by specialty
Medicine in general Gastroenterology Pneumology
Clinical immunology Psychosomatic Internal Medicine Infectious disease
Geriatrics Chest surgery Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy of anti-inflammatory drugs (Fluticason propionate or Montelukast)to patients of prolonged cough at early phase use.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change rate of cough score.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Fluticason propionate is administrated.
Interventions/Control_2 Montelukast is administrated.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1, Sex and age : No object.
2, Hospitalization or out patients : No object.
3, Non-smoking patient (By prohibition of smoking and past history of cigarette smoking include a smoking patient within 10pack-year more than three months).
4, Prolonged and/or chronic cough was continuing more than three weeks.
5, The patient who was able to acquire an agreement by the document.
Key exclusion criteria 1, Patients with the shadow by chest X-rays.
2, Patients who heard fine crackle.
3, Patients that consultation two weeks later is impossible.
4, Patients who give a clear asthma attack.
5, Patients who merges heart failure.
6, Patients who is running a fever.
7, Patients who is infected with serious respiratory illnesses such as activity-related tuberculosis or lung cancer.
8, ACE inhibitor taking patients.
9, Side effect that is serious for an ingredient of the study medicine or a patient with the anamnesis of the erythrism.
10,Patients whom it was judged a doctor not to be suitable as an object of the studies.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohda, Yuji
Organization Kinki University
Division name Respiratory medicine and allergology
Zip code
Address Osakasayama-shi, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kinki University
Division name Respiratory medicine and allergology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Kansai Asthma Research Network(KARN)
Institute
Department

Funding Source
Organization Japan Allergy Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2009 Year 08 Month 21 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
2009 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 21 Day
Last modified on
2017 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.