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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Seretide Diskus; Drug: HCP0910

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521455

HM-FTOL-101

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

HCP0910

Experimental group

Description:

Fluticasone /salmeterol 250/50 combination capsule

Treatment:

Drug: HCP0910

Seretide Diskus

Active Comparator group

Description:

Seretide 250 Diskus

Treatment:

Drug: Seretide Diskus