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

PHASE4CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

April 22, 2019

Primary Completion Date

May 9, 2021

Study Completion Date

May 9, 2021

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.

Trial Locations (13)

100044

Peking University People's Hospital, Beijing

163411

Daqing Oil Field Hospital, Daqing

266011

QingDao Municipal Hospital, Qingdao

272000

Affiliated Hospital of Jining Medical University, Jining

300393

Tianjin First Central Hospital, Tianjin

510650

The First Affiliated Hospital of Jinan University, Guangzhou

514031

Meizhou People's Hospital, Meizhou

050017

The Second Hospital of Hebei Medical University, Shijiazhuang

014000

Bao Gang Hospital, Baotou

010100

The Affiliated Hospital of Inner Mongolia Medical University, Hohhot

Unknown

Meiheko Central Hospital, Tonghua

030001

The First Affiliated Hospital of Shanxi Medical University, Taiyuan

030012

Shanxi Provincial People's Hospital, Taiyuan

All Listed Sponsors
collaborator

GCP ClinPlus Co., Ltd.

UNKNOWN

collaborator

Beijing Aicomer Pharmaceutical Technology Co., Ltd.

UNKNOWN

collaborator

Key Tech

UNKNOWN

collaborator

Healthcare Inc

UNKNOWN

collaborator

Peking University People's Hospital

OTHER

collaborator

Beijing Friendship Hospital

OTHER

collaborator

Tianjin First Central Hospital

OTHER

collaborator

Bao Gang Hospital

UNKNOWN

collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

collaborator

Beijing Yi Hua Hospital Management Co., Ltd

UNKNOWN

collaborator

The Second Hospital of Hebei Medical University

OTHER

collaborator

The First Affiliated Hospital of Shanxi Medical University

OTHER

collaborator

Shaanxi Provincial People's Hospital

OTHER

collaborator

Jining Medical University

OTHER

collaborator

Qingdao Municipal Hospital

OTHER

collaborator

Daqing Oil Field Hospital

OTHER

collaborator

First Affiliated Hospital of Jinan University

OTHER

collaborator

Meizhou People's Hospital

OTHER

collaborator

Meiheko Central Hospital

UNKNOWN

lead

Intech Biopharm Ltd.

INDUSTRY

NCT05152355 - Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients | Biotech Hunter | Biotech Hunter