UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%
Title of the study (Brief title)	Efficacy and safety of inhaled formoterol in Japanese COPD patients with %FEV1>=80%
Region	Japan

Condition
Condition	Japanese COPD patients with %FEV1>=80%
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to evaluate the efficacy and safety of formoterol in japanese COPD patients with %FEV1>=80%
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is change from baseline FEV1 to the end of tratment period in FEV1 60-min post-dose.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients receives inhaled formoterol 9 micro g twice daily via turbuhaler for 12 weeks
Interventions/Control_2
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	Male and female patients >= 40 years of age with a clinical diagnosis of COPD (post-bronchodilator FEV1 >= 80% of predicted norma, and post-bronchodilator FEV1/FVC < 70%) are eligible for inclusion. Patients are also required to have a crrent or previous smoking history of >= 10 pack-years.
Key exclusion criteria	Key exclusion criteria ware: a history or current clinical diagnosis of asthma or atopic disease such as allergic rhinitis; positive to specific IgE for environmental allergens; positive results of a methacholine inhalation challenge (<10,000 micro g/ml); use of long acting beta2-aganist, long acting muscarinic antagonist, theophylline, inhaled/oral/intravenous steroid, leukotriene receptor antagonist; sensitivity to the study drug; poor inhalation technique of the study drug; exhaled nitric oxide over 22 ppb in ex smoker or 18 ppb in current smoker (NIOX MINO); respiratory infection or respiratory tract disorder other than COPD; unstable ischemic heart disease or any other relevant cardiovascular disorder; women of childbearing potential or of breast-feeding; mental disorder or psychiatric symptom; several medical conditions prohibiting partitipation
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuo Kasahara
Organization	Kanazawa University Hospital
Division name	Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2000
Email	kasa1237@gmail.com

Public contact
Name of contact person	Johsuke Hara
Organization	Cellular Transplantation Biology, Kanazawa University Graduate School of Medicine
Division name	Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2276
Homepage URL
Email	hara0728@gmail.com

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Respiratory Medicine, Kanazawa University Hospital
Organization
Division
Category of Funding Organization	Other
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	2015 Year 09 Month 25 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 28 Day
Anticipated trial start date	2015 Year 09 Month 14 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	2015 Year 09 Month 25 Day
Last modified on	2017 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021938