UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022040 |
|---|---|
| Receipt number | R000023905 |
| Scientific Title | A multicenter randomized controlled crossover trial comparing the efficacy of LABA or LAMA in patient with COPD |
| Date of disclosure of the study information | 2016/04/24 |
| Last modified on | 2021/04/28 17:14:38 |
* 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
A multicenter randomized controlled crossover trial comparing the efficacy of LABA or LAMA in patient with COPD
Acronym
Investigation of treatment response in patient with COPD
Scientific Title
A multicenter randomized controlled crossover trial comparing the efficacy of LABA or LAMA in patient with COPD
Scientific Title:Acronym
Investigation of treatment response in patient with COPD
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the background factors of the patients who showed different treatment responses in being administered tiotropium and indacaterol. The patients were in the second or third stage of COPD. The medicine was administered in order, not simultaneously.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the background factors of the patients who showed significant differences through a pulmonary function test four weeks after the intervention.
Key secondary outcomes
To investigate the background factors of the patients who showed significant differences through CAT, TDI and IPAQ four weeks after the intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
We evaluate the result after the patients inhaled tiotropium for four weeks. Then, we switch from tiotropium to indicaterol, observe the progress for four weeks, and evaluate the result.
Interventions/Control_2
We evaluate the result after the patients inhaled indicaterol for four weeks. Then, we switch from indicaterol to tiotropium, observe the progress for four weeks, and evaluate the result.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)A Patient who is visiting our outpatient clinic, is over 40 years of age, and has smoking history
2)A patient who is classified into the second or third stage of COPD in pulmonary function test.
3)A patient who smoke 1 pack per day for 10 years or more
4)A patient who agreed to participate in the study with the written informed consent
Key exclusion criteria
1)A patient who cannot be performed a respiratory function test appropriately
2)A Patients with asthma.
3)A patients who have has experienced an acute COPD exacerbation or respiratory tract infection within the past 4 weeks prior to the informed consent
4)A patients with advanced malignant tumor
5)A patients who are is pregnant
6)A patients who are is allergic to tiotropium or ipratropium
7)A patients receiving oxygen inhalation for more than 15 hours/day
8) A patient whom the doctor in charge judged unsuitable as subjected is excluded.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Sagara |
Organization
Showa University School of Medicine
Division name
Division of Allergology and Respiratory Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
TEL
03-3784-8704
sagarah@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kuniaki |
| Middle name | |
| Last name | Hirai |
Organization
Showa University School of Medicine
Division name
Division of Allergology and Respiratory Medicine
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
TEL
03-3784-8000
Homepage URL
medi123@infoseek.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, JAPAN
Tel
03-3784-8000
ctsc.admin@ofc.showa-u.ac.jp
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
| 2016 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f3.cgi
Number of participants that the trial has enrolled
40
Results
The examination was finished without a clear harmful phenomenon.
The final analysis had not been finished, but LAMA accepted the patient who was easy to be effective.
The objective effect did not accord with the impression of the patient for the drug.
The analysis was over and was announced at the Respiratory Society of 2018.
Results date posted
| 2019 | Year | 11 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The clinical characteristics of participating patients were not significantly different from those of previous studies.
Participant flow
After two types of bronchodilators were crossed over and inhaled, an objective evaluation and a subjective evaluation were performed.
Adverse events
There were no adverse events in the patient.
Outcome measures
We did not find any characteristic results in objective evaluation items such as respiratory function, CAT, and mMRC and subjective evaluation items.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 26 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 26 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 26 | Day |
Other
Other related information
We excluded Yamanashi red cross hospital.
We are going to concluding our study when about 60 patients are included.
It is because, more than patients will not participate in our study.
So, we are going to analyze about 60 people now.
Management information
Registered date
| 2016 | Year | 04 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023905
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
