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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019373
Receipt No. 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

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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
Email 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
Email eklira@mebix.co.jp

Sponsor
Institute Tohno-Chuo Clinic
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022399

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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