Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Se... | NCT01521455

Studies
Therapeutic Equivalence Study of HCP0910 250/50 Mcg to Seretide 250 Diskus in Asthmatic Patients

NCT01521455

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Aug 23, 2013Estimated

Enrollment

56Actual

Phase

Phase 1

Conditions

Asthma

Interventions

HCP0910
Seretide Diskus

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jan 26, 2012

First Submission Date that Met QC Criteria

Jan 26, 2012

First Posted Date

Jan 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2013

Last Update Posted Date

Aug 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to prove that HCP0910 is therapeutically equivalent to Seretide 250 Diskus when repeatedly dosed to Asthmatic patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HCP0910	Experimental	Fluticasone /salmeterol 250/50 combination capsule	Drug: HCP0910
Seretide Diskus	Active Comparator	Seretide 250 Diskus	Drug: Seretide Diskus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HCP0910	Drug	250/50, BID for 2 weeks	HCP0910
Seretide Diskus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mean change of morning predose FEV1 from baseline		day 14

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 20 ~ 75 inclusive
Asthmatic diagnosis in more than 12 weeks from screening day
Shows more than 12 % increase, and 200mL increase in FEV1 measure on Visit 2

Exclusion Criteria:

Maintain controlled asthma for more than 4 weeks before screening
Diagnosed as a severe asthmatic patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kyung-mi Park, Ph.D	Hanmi Pharmaceutical Co.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soon Chun Hyang University Hospital Bucheon		Bucheon-si	Gyunggi -do		South Korea
Ajou University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided