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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01521455
First received: January 26, 2012
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Asthma
Drug: HCP0910
Drug: Seretide Diskus
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Open, Multi-center, Cross Over Study to Evaluate the Therapeutic Equivalence of Repeated Dose of HCP0910 250/50 μg to SeretideTM 250 DiskusTM in Asthmatic Patients

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • mean change of morning predose FEV1 from baseline [ Time Frame: day 14 ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCP0910
Fluticasone /salmeterol 250/50 combination capsule
Drug: HCP0910
250/50, BID for 2 weeks
Active Comparator: Seretide Diskus
Seretide 250 Diskus
Drug: Seretide Diskus
250/50, BID for 2 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01521455

Locations
Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
Bucheon, Gyunggi -do, Korea, Republic of
Ajou University Hospital
Suwon, Gyunggi -do, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Seoul National University
Seoul, Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Hanyang University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Study Director: Kyung-mi Park, Ph.D Hanmi Pharmaceutical Co.
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01521455     History of Changes
Other Study ID Numbers: HM-FTOL-101
Study First Received: January 26, 2012
Last Updated: August 22, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on October 01, 2014