Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients

Summary

The primary objective of this study is to compare the efficacy and safety of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID in Chinese mild to moderate Asthma patients.

Conditions

• Asthma

Interventions

DRUG

Budesonide 200 microgram/Puff, HFA MDI

Participants will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.

DRUG

Budesonide 100 microgram/Actuation Powder for Inhalation

Participants will inhaled 4 puffs of budesonide 100 mcg DPI bid (am 08:00 and pm 16:00) for 4 weeks, if necessary rescue Ventolin (Salbutamol Sulfate) 100 mcg 2 puffs could be used with maximum daily dose of 8 puffs.

Sponsors & Collaborators

• GCP ClinPlus Co., Ltd.

  collaborator UNKNOWN

• Beijing Aicomer Pharmaceutical Technology Co., Ltd.

  collaborator UNKNOWN

• Key Tech

  collaborator UNKNOWN

• Healthcare Inc

  collaborator UNKNOWN

• Peking University People's Hospital

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• Tianjin First Central Hospital

  collaborator OTHER

• Bao Gang Hospital

  collaborator UNKNOWN

• The Affiliated Hospital of Inner Mongolia Medical University

  collaborator OTHER

• Beijing Yi Hua Hospital Management Co., Ltd

  collaborator UNKNOWN

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• The First Affiliated Hospital of Shanxi Medical University

  collaborator OTHER

• Shaanxi Provincial People's Hospital

  collaborator OTHER

• Jining Medical University

  collaborator OTHER

• Qingdao Municipal Hospital

  collaborator OTHER

• Daqing Oil Field Hospital

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• Meiheko Central Hospital

  collaborator UNKNOWN

• Intech Biopharm Ltd.

  lead INDUSTRY

Principal Investigators

• Wei Hsiu Wu, MBA · Intech Biopharm

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-22

Primary Completion

2021-05-09

Completion

2021-05-09

Countries

• China

Study Locations