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Completed

NCT Number: NCT01521455

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, Gyunggi -do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HCP0910

Drug

250/50, BID for 2 weeks

SERETIDE Diskus

Drug

250/50, BID for 2 weeks

Primary outcomes

  1. mean change of morning predose FEV1 from baseline

    Time frame: day 14

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 30, 2012
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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