Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byBrian Lipworth, PhD, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AstraZeneca
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.
Eligibility Criteria
Inclusion Criteria
Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 > 60 %
Methacholine PC20 < 4 mg/mL
ICS taking ≤ 1000 μg BDP per day, or equivalent
Treatment Details
Interventions
- Budesonide CFC (Corticosteroid)
- Budesonide HFA (Corticosteroid)
Participant Groups
4Treatment groups
Active Control
Group I: Budesonide Hydrofluoroalkane (HFA) 100Active Control1 Intervention
Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
Group II: Budesonide CFC 400Active Control1 Intervention
Budesonide CFC 400 mcg twice daily for 2 weeks
Group III: Budesonide Chlorofluorocarbon (CFC) 100Active Control1 Intervention
Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
Group IV: Budesonide HFA 400Active Control1 Intervention
Budesonide HFA 400 mcg twice daily for 2 weeks
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SiteKing of Prussia, PA
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor