UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000860 |
|---|---|
| Receipt number | R000001035 |
| Scientific Title | An Open-Label, Randomized, Multicenter Study to Evaluate the Additive Effects of Montelukast and/or Salmeterol on Asthma Control Levels in Patients with Poorly Controlled Asthma Treated with Moderate doses of Inhaled Corticosteroid |
| Date of disclosure of the study information | 2007/10/22 |
| Last modified on | 2010/04/26 15:08:38 |
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Basic information
Public title
An Open-Label, Randomized, Multicenter Study to Evaluate the Additive Effects of Montelukast and/or Salmeterol on Asthma Control Levels in Patients with Poorly Controlled Asthma Treated with Moderate doses of Inhaled Corticosteroid
Acronym
Tokyo Respiratory Eminent Study for Clinical Unmet Effectiveness Study
(To Rescue)
Scientific Title
An Open-Label, Randomized, Multicenter Study to Evaluate the Additive Effects of Montelukast and/or Salmeterol on Asthma Control Levels in Patients with Poorly Controlled Asthma Treated with Moderate doses of Inhaled Corticosteroid
Scientific Title:Acronym
Tokyo Respiratory Eminent Study for Clinical Unmet Effectiveness Study
(To Rescue)
Region
| Japan |
Condition
Condition
Bronchial Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the additive effects of Montelukast and/or Salmeterol on asthma control levels in patients with poorly controlled asthma treated with moderate doses of inhaled corticosteroid
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asthma control levels
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
Additive and consecutive treatment of Salmeterol and Montelukast
Interventions/Control_2
Additive and consecutive treatment of Montelukast and Salmeterol
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Poorly Controlled Asthma Treated with Moderate doses of Inhaled Corticosteroid
Key exclusion criteria
Patients with COPD
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahide NAGASE |
Organization
The University of Tokyo,
Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo,
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
takahide-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo,
Graduate School of Medicine,
Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo University Hospital
Organization
Division
Category of Funding Organization
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
| 2007 | Year | 10 | Month | 22 | 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
| 2007 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 22 | Day |
Last modified on
| 2010 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001035
