UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Montelukast to prolonged cough.
Title of the study (Brief title)	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	Tohda, Yuji
Organization	Kinki University
Division name	Respiratory medicine and allergology
Address	Osakasayama-shi, Osaka
TEL
Email

Public contact
Name of contact person
Organization	Kinki University
Division name	Respiratory medicine and allergology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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