UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy evaluation of Tiotropium Respimat with AeroChamber Plus
Title of the study (Brief title)	Inhalation therapy using Tiotropium Respimat with AeroChamber Plus
Region	Japan

Condition
Condition	COPD
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficay of Tiotropium Respimat with AeroChamber Plus on lung function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of forced expiratory volume in 1 second (FEV1) after inhalation therapy
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Maneuver
Interventions/Control_1	Inhalation of Tiotropium Respimat with AeroChamber Plus
Interventions/Control_2	Inhalation of Tiotropium Respimat without AeroChamber Plus
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients >= 20 years of age with a diagnosis of stage 1 - 3 COPD. 2. Patients continuing use of tiotropium respimat. 3. Patients planning to start tiotropium respimat. 4. Patients who are not using long acting be-ta 2-agonist (LABA) or inhaled corticosteroid (ICS)/LABA combination.
Key exclusion criteria	1. Known severe allergy to any drugs. 2. Patients with benign prostatic hypertrophy or glaucoma. 3. Patients who cannot parchase AeroChamber Plus. 4. Patients who cannot use tiotropium respimat with inhalation assistance.
Target sample size	20

Research contact person
Name of lead principal investigator	Takashi Ogasawara
Organization	Hamamatsu Medical Center
Division name	The department of respiratory medicine
Address	328 Tomitsuka, Hamamatsu, Shizuoka
TEL	053-453-7111
Email	shikatarawasagao@gmail.com

Public contact
Name of contact person	Takashi Ogasawara
Organization	Hamamatsu Medical Center
Division name	Department of respiratory medicine
Address	328 Tomitsuka, Hamamatsu, Shizuoka
TEL	053-453-7111
Homepage URL
Email	shikatarawasagao@gmail.com

Sponsor
Institute	Hamamatsu medical center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 05 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 10 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 17 Day
Last modified on	2016 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016289