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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01521455
First Posted: January 30, 2012
Last Update Posted: August 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
  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
Intervention Model: Crossover Assignment
Masking: None (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

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Hanyang University Hospital
Seoul, Korea, Republic of
Samsung medical center
Seoul, Korea, Republic of
Seoul National University
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Study Director: Kyung-mi Park, Ph.D Hanmi Pharmaceutical Co.
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01521455     History of Changes
Other Study ID Numbers: HM-FTOL-101
First Submitted: January 26, 2012
First Posted: January 30, 2012
Last Update Posted: August 23, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics