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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05152355
• Other study ID #: INTB011H01
• Status: Completed
• Phase: Phase 4
• Start date: April 22, 2019
• Est. completion date: May 9, 2021

Study information

• Verified date: August 2021
• Source: Intech Biopharm Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 9, 2021
• Est. primary completion date: May 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Bao Gang Hospital	Baotou	Inner Mongolia
China	Peking University People's Hospital	Beijing	Beijing
China	Daqing Oil Field Hospital	Daqing	Heilongjiang
China	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Affiliated Hospital of Jining Medical University	Jining	Shandon
China	Meizhou People's Hospital	Meizhou	Guangdong
China	QingDao Municipal Hospital	Qingdao	Shandon
China	The Second Hospital of Hebei Medical University	Shijia Zhuang	He Bei Sheng
China	Shanxi Provincial People's Hospital	Taiyuan	Shan XI Sheng
China	The First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shan XI Sheng
China	Tianjin First Central Hospital	Tianjin
China	Meiheko Central Hospital	Tonghua	Jilin

Sponsors (20)

Lead Sponsor

Collaborator

Intech Biopharm Ltd.

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change from base line of FVC	The changes from base line of FVC after 4 weeks treatment	Week 0 and 4
Secondary	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
Secondary	Change from base line of FEF25%	The changes from base line of FEF25% after 4 weeks treatment	Week 0 and 4
Secondary	Change from base line of FEF50%	The changes from base line of FEF50% after 4 weeks treatment	Week 0 and 4
Secondary	Change from base line of FEF75%	The changes from base line of FEF75% after 4 weeks treatment	Week 0 and 4
Secondary	Change from base line of ACT	The change from base line of Asthma Control Test after 4 weeks treatment	Week 0, 2 and 4
Secondary	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
Secondary	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
Secondary	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
Secondary	Subjects number with acute exacerbation	The total number of subjects with acute exacerbation during treatment period	during week 0 to 4
Secondary	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
Secondary	Percentage of days without symptom	The percentage of days without asthma symptom during the treatment period	during week 0 to 4
Secondary	Percentage of days without using rescue medicine	The percentage of days without using rescue medicine during the treatment period	during week 0 to 4