UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002360 |
|---|---|
| Receipt number | 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 00:18:19 |
* 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
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
Sponsor or person
Institute
Kansai Asthma Research Network(KARN)
Institute
Department
Personal name
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
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
Value
https://center6.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 |
