UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019373 |
|---|---|
| Receipt number | R000022399 |
| Scientific Title | Evaluation of device operability of Genuair inhaler and Respimat inhaler in patients with chronic obstructive pulmonary disease (COPD) |
| Date of disclosure of the study information | 2015/10/22 |
| Last modified on | 2016/07/27 18:44:05 |
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Basic information
Public title
Evaluation of device operability of Genuair inhaler and Respimat inhaler in patients with
chronic obstructive pulmonary disease (COPD)
Acronym
Evaluation of device operability of Genuair inhaler and Respimat inhaler in patients with
chronic obstructive pulmonary disease (COPD)
Scientific Title
Evaluation of device operability of Genuair inhaler and Respimat inhaler in patients with
chronic obstructive pulmonary disease (COPD)
Scientific Title:Acronym
Evaluation of device operability of Genuair inhaler and Respimat inhaler in patients with
chronic obstructive pulmonary disease (COPD)
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the device operability including operation errors (pitfalls) in the inhalation procedure by comparing optimal operation rate (%) between Genuair inhaler and Respimat inhaler
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Optimal operation rate by investigator
Key secondary outcomes
Acquirement rate of inhalation procedure
- Number of IPGs(inhalation procedure guidances)
- Subject questionnaire using questionnaire on inhaler
- Evaluation of pitfalls evaluated by investigator.
- Dyspnea (mMRC questionnaire)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
One inhalation (400 microgram as aclidinium) is administered with Genuair inhaler twice daily for 2 weeks
Interventions/Control_2
Two inhalations (5 microgram as tiotropium) are administered with Respimat inhaler once daily for 2 weeks
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
Patients who meet all the conditions below at Week 0 will be eligible as subjects.
(1) Having provided written consent prior to participation in the study
(2) Age more than 40 years
(3) Having COPD with post-bronchodilator FEV1/FVC <70% within the past 3 months
(4) Having smoking history more than 10 pack-years
(5) No previous use of Genuair or Respimat
(6) Having sufficient maniphalanx motor function for device operation
(7) Capable of understanding the device operation sufficiently
Key exclusion criteria
Patients who meet any of the conditions below at Week 0 will not be selected as subjects.
(1) Having evidence of bronchial asthma
(2) Having serious respiratory, cardiac, digestive (hepatic, renal, or pancreatic), urinary, hematological, or renal disease or other serious concurrent medical condition that would interfere with participation in the study
(3) Having deformity or paralysis of maniphalanx which, in the opinion of the principal investigator, will preclude an optimal operation of the study device
(4) Cannot understand the inhalation procedure because of dementia, etc., in the opinion of the principal investigator
(5) Having contraindication of anticholinergic agents
(6) Having a history of adverse reactions to anticholinergic agents
(7) Having malignant tumor or a history of malignant tumor within the past 5 years
(8) Inadequate for the study, in the opinion of the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ohbayashi |
Organization
Tohno-Chuo Clinic
Division name
Clinic Director
Zip code
Address
1-14-1 Matsugase-cho, Mizunami, Gifu 509-6134, Japan
TEL
0572-67-1118
ohbayasi@nn.iij4u.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhide Mori |
Organization
Mebix, Inc.
Division name
Research promotion division
Zip code
Address
Akasaka Intercity 11F, 1-11-44
TEL
03-6229-8936
Homepage URL
eklira@mebix.co.jp
Sponsor or person
Institute
Tohno-Chuo Clinic
Institute
Department
Personal name
Funding Source
Organization
KYORIN Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit 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
東濃中央クリニック/Tohno-Chuo Clinic
Other administrative information
Date of disclosure of the study information
| 2015 | 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
| 2015 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022399
