臨床研究等提出・公開システム

Date of registration	Mar. 25, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222805

Scientific Title	A randomized, double-blind, placebo-controlled, parallel group study to explore the efficacy of PTR-36 in adult patients with bronchial asthma (Phase 2)
Public Title	A study to explore the efficacy of PTR-36 in adult patients with asthma

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Teijin Pharma Limited
	Address	clintrials@teijin.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Teijin Pharma Limited
	Address	clintrials@teijin.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		150
Study Type		Interventional
Study Design	Study Design	Randomized, double-blind, placebo-controlled, multi-center, parallel-group
Study Design	Objective
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	- Asthma patients receiving a moderate-dose ICS or a moderate-dose ICS/long-acting beta2-agonist(LABA)combination therapy for more than 4 weeks - FEV1 >=60% and =<90% of the predicted normal value at randomization
	Exclusion Criteria	- BMI >= 30 - smoking history > 10 pack year - diagnosed with COPD
	Minimum Age	20age old over
	Maximum Age	75age old under
	Gender	Both
Health Condition or Problem Studied		asthma
Intervention(s)		investigational material(s) Generic name etc : PTR-36 INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and Administration for Investigational material : oral administration control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : oral administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Changes in mPEF from time of randomization to final evaluation
Secondary Outcome		Changes in pre-bronchodilator FEV1, ACQ7, and FeNO

Primary Sponsor	TEIJIN PHARMA LIMITED
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-152857
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	July. 25, 2016	Detail	Changes
3	July. 25, 2016	Detail	Changes
2	Mar. 25, 2015	Detail	Changes
1	Mar. 25, 2015	Detail

List of change history