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

Hanmi Pharmaceutical Company Limited56 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

HCP0910DRUG

250/50, BID for 2 weeks

Seretide DiskusDRUG

250/50, BID for 2 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (7)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyunggi -do, South Korea

Ajou University Hospital

Suwon, Gyunggi -do, South Korea

Asan Medical Center

Seoul, South Korea

Ewha Womans University Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

mean change of morning predose FEV1 from baseline

Time frame: day 14

Data from ClinicalTrials.gov

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