Clinical trial NCT05152355: Clinical Equivalence of Budesonide HFA MDI Versus Budesonide Turbuhaler in Mild to Moderate Chinese Asthma Patients
Official title: Multi-center, Single Blind, Randomized, Parallel Study to Compare the Clinical Efficacy and Safety of Dusama (Budesonide) HFA MDI With Pulmicort (Budesonide) Turbuhaler in Mild to Moderate Chinese Asthma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: budesonide
MDI
DPI
China
Asthma
Lead sponsor: Intech Biopharm Ltd.
Sponsor class: INDUSTRY
Collaborators: name: GCP ClinPlus Co., Ltd.
name: Beijing Aicomer Pharmaceutical Technology Co., Ltd.
name: Key Tech
name: Healthcare Inc
name: Peking University People's Hospital
name: Beijing Friendship Hospital
name: Tianjin First Central Hospital
name: Bao Gang Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Beijing Yi Hua Hospital Management Co., Ltd
name: The Second Hospital of Hebei Medical University
name: The First Affiliated Hospital of Shanxi Medical University
name: Shaanxi Provincial People's Hospital
name: Jining Medical University
name: Qingdao Municipal Hospital
name: Daqing Oil Field Hospital
name: First Affiliated Hospital of Jinan University
name: Meizhou People's Hospital
name: Meiheko Central Hospital
First posted: 2021-12-09
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A total of 270 Chinese mild to moderate Asthma patients will be enrolled and 230 will be completed in this multi-center, randomized, single blind, parallel efficacy and safety comparison study of budesonide HFA MDI 200 mcg 2 puffs BID versus budesonide DPI (Turbuhaler) 100 mcg 4 puffs BID.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 70 years old and diagnosed as Asthma in clinics
* Diagnosed as Asthma according to the 2016 Asthma guidance of Chinese Thoracic Society, and without administer corticosteroids within three months, either new or old patients
* FEV1 predicted ≧ 60%
* Patients is willing to participate the study and signed the Informed Consent Form

Exclusion Criteria:

* Allergy to budesonide or salbutamol
* Infections of Respiratory tract, nasal-sinus and ear within 4 weeks before enrollment
* Severe nasal allergy and need the treatment of corticostreoids and histamines.
* Severe cardiovascular disease history
* Has used leukotriene receptor antagonist (Montelukast, Pranlukast, Zafirlukast etc.) within 2 weeks before enrollment
* Severe cognition or mental disorder and can not cooperation with the treatment
* Significant liver dysfunction, AST, ALT \> 3 X normal upper limits, CR \> 1.5 X normal upper limits
* Patients with uncontrolled diabetes or fasting blood glucose \> 10 mmol/L
* Patients currently receiving beta-antagonists or beta-agonists treatment (including eye drops)
* Patients who has contraindications to beta2-agonists
* Patients who has participated others drug's clinical study within three months
* Female patients who are pregnant or lactation or prepare to pregnant
* Any conditions which the investigators considered not suitable to enrolled

Primary outcomes:
measure: Change from base line of FEV1
timeFrame: Week 0, 2 and 4
Secondary outcomes:
measure: Mean change from base line of morning and evening PEF
timeFrame: Week 0 and 4
measure: Change from base line of FVC
timeFrame: Week 0 and 4
measure: Change from base line of FEV1/FVC ratio
timeFrame: Week 0 and 4
measure: Change from base line of FEF25%
timeFrame: Week 0 and 4
measure: Change from base line of FEF50%
timeFrame: Week 0 and 4
measure: Change from base line of FEF75%
timeFrame: Week 0 and 4
measure: Change from base line of ACT
timeFrame: Week 0, 2 and 4
measure: Daily PEF variability
timeFrame: during week 0 to 4
measure: Weekly PEF variability
timeFrame: during week 0 to 4
measure: Changes of day time and night time symptom
timeFrame: during week 0 to 4
measure: Subjects number with acute exacerbation
timeFrame: during week 0 to 4
measure: Total amount of rescue medication, Ventolin 100 mcg inhaler, used
timeFrame: during week 0 to 4
measure: Percentage of days without symptom
timeFrame: during week 0 to 4
measure: Percentage of days without using rescue medicine
timeFrame: during week 0 to 4
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Meizhou
country: China
facility: Meizhou People's Hospital
state: Guangdong
city: Shijia Zhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: He Bei Sheng
city: Daqing
country: China
facility: Daqing Oil Field Hospital
state: Heilongjiang
city: Baotou
country: China
facility: Bao Gang Hospital
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Tonghua
country: China
facility: Meiheko Central Hospital
state: Jilin
city: Taiyuan
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
state: Shan XI Sheng
city: Taiyuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shan XI Sheng
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandon
city: Qingdao
country: China
facility: QingDao Municipal Hospital
state: Shandon
city: Tianjin
country: China
facility: Tianjin First Central Hospital
Study officials:
affiliation: Intech Biopharm
name: Wei Hsiu Wu, MBA
role: STUDY_CHAIR
References: