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

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 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


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

Value
https://center6.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