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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Budesonide 200 microgram/Puff, HFA MDI
Budesonide 100 microgram/Actuation Powder for Inhalation
Sponsored by
Intech Biopharm Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring budesonide, MDI, DPI, China, Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University People's Hospital
  • The First Affiliated Hospital of Jinan University
  • Meizhou People's Hospital
  • The Second Hospital of Hebei Medical University
  • Daqing Oil Field Hospital
  • Bao Gang Hospital
  • The Affiliated Hospital of Inner Mongolia Medical University
  • Meiheko Central Hospital
  • The First Affiliated Hospital of Shanxi Medical University
  • Shanxi Provincial People's Hospital
  • Affiliated Hospital of Jining Medical University
  • QingDao Municipal Hospital
  • Tianjin First Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Budesonide HFA MDI (Treatment A)

Budesonide DPI (Turbuhaler) (Treatment B)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from base line of FEV1
The change from base line of forced expiratory volume in one second after 4 weeks treatment

Secondary Outcome Measures

Mean change from base line of morning and evening PEF
The mean change from base line of morning and evening PEF (peak expiratory flow)
Change from base line of FVC
The changes from base line of FVC after 4 weeks treatment
Change from base line of FEV1/FVC ratio
The changes from base line of FEV1/FVC ratio after 4 weeks treatment
Change from base line of FEF25%
The changes from base line of FEF25% after 4 weeks treatment
Change from base line of FEF50%
The changes from base line of FEF50% after 4 weeks treatment
Change from base line of FEF75%
The changes from base line of FEF75% after 4 weeks treatment
Change from base line of ACT
The change from base line of Asthma Control Test after 4 weeks treatment
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
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
Changes of day time and night time symptom
The changes of day time and night time symptom during the treatment period
Subjects number with acute exacerbation
The total number of subjects with acute exacerbation during treatment period
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
Percentage of days without symptom
The percentage of days without asthma symptom during the treatment period
Percentage of days without using rescue medicine
The percentage of days without using rescue medicine during the treatment period

Full Information

First Posted
July 30, 2020
Last Updated
November 28, 2021
Sponsor
Intech Biopharm Ltd.
Collaborators
GCP ClinPlus Co., Ltd., Beijing Aicomer Pharmaceutical Technology Co., Ltd., Key Tech, Healthcare Inc, Peking University People's Hospital, Beijing Friendship Hospital, Tianjin First Central Hospital, Bao Gang Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Beijing Yi Hua Hospital Management Co., Ltd, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Shanxi Medical University, Shaanxi Provincial People's Hospital, Jining Medical University, Qingdao Municipal Hospital, Daqing Oil Field Hospital, First Affiliated Hospital of Jinan University, Meizhou People's Hospital, Meiheko Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05152355
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
May 9, 2021 (Actual)
Study Completion Date
May 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intech Biopharm Ltd.
Collaborators
GCP ClinPlus Co., Ltd., Beijing Aicomer Pharmaceutical Technology Co., Ltd., Key Tech, Healthcare Inc, Peking University People's Hospital, Beijing Friendship Hospital, Tianjin First Central Hospital, Bao Gang Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Beijing Yi Hua Hospital Management Co., Ltd, The Second Hospital of Hebei Medical University, The First Affiliated Hospital of Shanxi Medical University, Shaanxi Provincial People's Hospital, Jining Medical University, Qingdao Municipal Hospital, Daqing Oil Field Hospital, First Affiliated Hospital of Jinan University, Meizhou People's Hospital, Meiheko Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
budesonide, MDI, DPI, China, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Single blind
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Budesonide HFA MDI (Treatment A)
Arm Type
Experimental
Arm Description
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
Arm Title
Budesonide DPI (Turbuhaler) (Treatment B)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Budesonide 200 microgram/Puff, HFA MDI
Other Intervention Name(s)
Duasma 200 mcg inhaler
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Budesonide 100 microgram/Actuation Powder for Inhalation
Other Intervention Name(s)
Pulmicort 100 mcg Turbuhaler
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from base line of FEV1
Description
The change from base line of forced expiratory volume in one second after 4 weeks treatment
Time Frame
Week 0, 2 and 4
Secondary Outcome Measure Information:
Title
Mean change from base line of morning and evening PEF
Description
The mean change from base line of morning and evening PEF (peak expiratory flow)
Time Frame
Week 0 and 4
Title
Change from base line of FVC
Description
The changes from base line of FVC after 4 weeks treatment
Time Frame
Week 0 and 4
Title
Change from base line of FEV1/FVC ratio
Description
The changes from base line of FEV1/FVC ratio after 4 weeks treatment
Time Frame
Week 0 and 4
Title
Change from base line of FEF25%
Description
The changes from base line of FEF25% after 4 weeks treatment
Time Frame
Week 0 and 4
Title
Change from base line of FEF50%
Description
The changes from base line of FEF50% after 4 weeks treatment
Time Frame
Week 0 and 4
Title
Change from base line of FEF75%
Description
The changes from base line of FEF75% after 4 weeks treatment
Time Frame
Week 0 and 4
Title
Change from base line of ACT
Description
The change from base line of Asthma Control Test after 4 weeks treatment
Time Frame
Week 0, 2 and 4
Title
Daily PEF variability
Description
The Daily PEF variability (= (daily highest PEF-daily lowest PEF)X2/((daily highest PEF+daily lowest PEF) X 100% during the whole treatment period
Time Frame
during week 0 to 4
Title
Weekly PEF variability
Description
The Weekly PEF variability (= (biweely highest PEF-biweekly lowest PEF)X2/((biweekly highest PEF+biweekly lowest PEF) X 100% during the whole treatment period
Time Frame
during week 0 to 4
Title
Changes of day time and night time symptom
Description
The changes of day time and night time symptom during the treatment period
Time Frame
during week 0 to 4
Title
Subjects number with acute exacerbation
Description
The total number of subjects with acute exacerbation during treatment period
Time Frame
during week 0 to 4
Title
Total amount of rescue medication, Ventolin 100 mcg inhaler, used
Description
The total amount of doses of rescue medication, Ventolin 100 mcg inhaler, used during the treatment period
Time Frame
during week 0 to 4
Title
Percentage of days without symptom
Description
The percentage of days without asthma symptom during the treatment period
Time Frame
during week 0 to 4
Title
Percentage of days without using rescue medicine
Description
The percentage of days without using rescue medicine during the treatment period
Time Frame
during week 0 to 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Hsiu Wu, MBA
Organizational Affiliation
Intech Biopharm
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
The First Affiliated Hospital of Jinan University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510650
Country
China
Facility Name
Meizhou People's Hospital
City
Meizhou
State/Province
Guangdong
ZIP/Postal Code
514031
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijia Zhuang
State/Province
He Bei Sheng
ZIP/Postal Code
050017
Country
China
Facility Name
Daqing Oil Field Hospital
City
Daqing
State/Province
Heilongjiang
ZIP/Postal Code
163411
Country
China
Facility Name
Bao Gang Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014000
Country
China
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010100
Country
China
Facility Name
Meiheko Central Hospital
City
Tonghua
State/Province
Jilin
Country
China
Facility Name
The First Affiliated Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shan XI Sheng
ZIP/Postal Code
030001
Country
China
Facility Name
Shanxi Provincial People's Hospital
City
Taiyuan
State/Province
Shan XI Sheng
ZIP/Postal Code
030012
Country
China
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining
State/Province
Shandon
ZIP/Postal Code
272000
Country
China
Facility Name
QingDao Municipal Hospital
City
Qingdao
State/Province
Shandon
ZIP/Postal Code
266011
Country
China
Facility Name
Tianjin First Central Hospital
City
Tianjin
ZIP/Postal Code
300393
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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