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

NCT05152355 | Completed Phase 4

• 1 other identifier: INTB011H01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 13

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.

Conditions

Asthma

Keywords

budesonide; MDI; DPI; China; Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Mean change from base line of morning and evening PEF

  Week 0 and 4

• Change from base line of FVC

  Week 0 and 4

• Change from base line of FEV1/FVC ratio

  Week 0 and 4

• Change from base line of FEF25%

  Week 0 and 4

• Change from base line of FEF50%

  Week 0 and 4

Study Arms (2)

Budesonide HFA MDI (Treatment A)

EXPERIMENTAL

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

Budesonide DPI (Turbuhaler) (Treatment B)

ACTIVE COMPARATOR

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

Interventions

Budesonide 200 microgram/Puff, HFA MDI DRUG

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.

Also known as: Duasma 200 mcg inhaler

Budesonide HFA MDI (Treatment A)

Budesonide 100 microgram/Actuation Powder for Inhalation DRUG

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.

Also known as: Pulmicort 100 mcg Turbuhaler

Budesonide DPI (Turbuhaler) (Treatment B)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (13)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, 510650, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050017, China

Location

Daqing Oil Field Hospital

Daqing, Heilongjiang, 163411, China

Location

Bao Gang Hospital

Baotou, Inner Mongolia, 014000, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010100, China

Location

Meiheko Central Hospital

Tonghua, Jilin, China

Location

Affiliated Hospital of Jining Medical University

Jining, Shandon, 272000, China

Location

QingDao Municipal Hospital

Qingdao, Shandon, 266011, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Shanxi Provincial People's Hospital

Taiyuan, Shanxi, 030012, China

Location

Tianjin First Central Hospital

Tianjin, 300393, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Nebulizers and Vaporizers; Inhalation; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Wei Hsiu Wu, MBA

  Intech Biopharm

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: December 9, 2021
• Study Start: April 22, 2019
• Primary Completion: May 9, 2021
• Study Completion: May 9, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)