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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide 200 microgram/Puff, HFA MDI; Drug: Budesonide 100 microgram/Actuation Powder for Inhalation

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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Tianjin, China, 300393
    • Tianjin First Central Hospital
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510650
      • The First Affiliated Hospital of Jinan University
    • Meizhou, Guangdong, China, 514031
      • Meizhou People's hospital
  • He Bei Sheng
    • Shijia Zhuang, He Bei Sheng, China, 050017
      • The Second Hospital of Hebei Medical University
  • Heilongjiang
    • Daqing, Heilongjiang, China, 163411
      • Daqing Oil Field Hospital
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014000
      • Bao Gang Hospital
    • Hohhot, Inner Mongolia, China, 010100
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jilin
    • Tonghua, Jilin, China
      • Meiheko Central Hospital
  • Shan XI Sheng
    • Taiyuan, Shan XI Sheng, China, 030001
      • The First Affiliated Hospital of Shanxi Medical University
    • Taiyuan, Shan XI Sheng, China, 030012
      • Shanxi Provincial People's Hospital
  • Shandon
    • Jining, Shandon, China, 272000
      • Affiliated Hospital of Jining Medical University
    • Qingdao, Shandon, China, 266011
      • Qingdao Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Budesonide HFA MDI (Treatment A); Participants assigned to Experimental arm will inhaled 2 puffs of budesonide 200 mcg HFA MDI bid (am 08:00 and pm 16:00) for 4 weeks	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.; Other Names: Duasma 200 mcg inhaler
Active Comparator: Budesonide DPI (Turbuhaler) (Treatment B); Participants assigned to Active Comparator arm will inhaled 4 puffs of budesonide 100 mcg powder for inhalation bid (am 08:00 and pm 16:00) for 4 weeks	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.; Other Names: Pulmicort 100 mcg Turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from base line of FEV1	The change from base line of forced expiratory volume in one second after 4 weeks treatment	Week 0, 2 and 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change from base line of morning and evening PEF	The mean change from base line of morning and evening PEF (peak expiratory flow)	Week 0 and 4
Change from base line of FVC	The changes from base line of FVC after 4 weeks treatment	Week 0 and 4
Change from base line of FEV1/FVC ratio	The changes from base line of FEV1/FVC ratio after 4 weeks treatment	Week 0 and 4
Change from base line of FEF25%	The changes from base line of FEF25% after 4 weeks treatment	Week 0 and 4
Change from base line of FEF50%	The changes from base line of FEF50% after 4 weeks treatment	Week 0 and 4
Change from base line of FEF75%	The changes from base line of FEF75% after 4 weeks treatment	Week 0 and 4
Change from base line of ACT	The change from base line of Asthma Control Test after 4 weeks treatment	Week 0, 2 and 4
Daily PEF variability	The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period	during week 0 to 4
Weekly PEF variability	The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period	during week 0 to 4
Changes of day time and night time symptom	The changes of day time and night time symptom during the treatment period	during week 0 to 4
Subjects number with acute exacerbation	The total number of subjects with acute exacerbation during treatment period	during week 0 to 4
Total amount of rescue medication, Ventolin 100 mcg inhaler, used	The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period	during week 0 to 4
Percentage of days without symptom	The percentage of days without asthma symptom during the treatment period	during week 0 to 4
Percentage of days without using rescue medicine	The percentage of days without using rescue medicine during the treatment period	during week 0 to 4

Collaborators and Investigators

• Sponsor: Intech Biopharm Ltd.
• Collaborators: Peking University People's Hospital; Beijing Friendship Hospital; The Second Hospital of Hebei Medical University; Qingdao Municipal Hospital; Shaanxi Provincial People's Hospital; First Affiliated Hospital of Jinan University; Tianjin First Central Hospital; The First Affiliated Hospital of Shanxi Medical University; The Affiliated Hospital of Inner Mongolia Medical University; Jining Medical University; Meizhou People's Hospital; Daqing Oil Field Hospital; GCP ClinPlus Co., Ltd.; Beijing Aicomer Pharmaceutical Technology Co., Ltd.; Key Tech; Healthcare Inc; Bao Gang Hospital; Beijing Yi Hua Hospital Management Co., Ltd; Meiheko Central Hospital
• Investigators: Study Chair: Wei Hsiu Wu, MBA, Intech Biopharm

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): May 9, 2021
• Study Completion (Actual): May 9, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: November 28, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: China; Asthma; budesonide; MDI; DPI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: INTB011H01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No