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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: HCP0910; Drug: Seretide Diskus

• Registration Number: NCT01521455
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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 available

Study Timeline

• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-30
• Study Start: 2012-02
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HCP0910	HCP0910	Fluticasone /salmeterol 250/50 combination capsule
Seretide Diskus	Seretide Diskus	Seretide 250 Diskus

Primary Outcome Measures

Name	Time	Method
mean change of morning predose FEV1 from baseline	day 14

Trial Locations

Locations (7)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of

Ajou University Hospital; 🇰🇷 Suwon, Gyunggi -do, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Gyunggi -do, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of