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Budesonide HFA

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Nov 7, 2012

Budesonide HFA development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Apr 2008

Budesonide HFA target and mechanism

Molecular targetNR3C1
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment99

FDA Designations

No designations recorded

Budesonide HFA clinical trials

Budesonide HFA · 1 trial · 1 indication

Phase 3 1
NCT00667992Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate AsthmaAsthma
COMPLETED99 Analytics
PHASE3COMPLETED
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)
Baseline and week 2

Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%. The ratio of Methacholine concentration measured at 2 weeks to that at Baseline.

Secondary Endpoints

Peak Exploratory Flow (PEF)
Baseline to week 2 recorded daily
FEV1 (Forced Expiratory Volume in 1 Second)
Baseline to week 2
FEF 25-75 (Forced Expiratory Flow 25-75)
Baseline and week 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Budesonide Hydrofluoroalkane (HFA) 100ACTIVE_COMPARATORBudesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
Budesonide HFA 400ACTIVE_COMPARATORBudesonide HFA 400 mcg twice daily for 2 weeks
Budesonide Chlorofluorocarbon (CFC) 100ACTIVE_COMPARATORBudesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
Budesonide CFC 400ACTIVE_COMPARATORBudesonide CFC 400 mcg twice daily for 2 weeks

Interventions

NameTypeDescription
Budesonide HFADRUGstandard daily inhaled dose
Budesonide CFCDRUGstandard daily inhaled dose
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 % * ICS taking ≤ 1000 μg BDP per day, or equivalent * Methacholine PC20 \< 4 mg/mL Exclusion Criteria: * Known or suspecte...

Countries:United StatesUnited Kingdom
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Frequently asked questions about Budesonide HFA

What is Budesonide HFA used for?

Budesonide HFA is an inhaled corticosteroid formulation developed for the treatment of asthma. It is delivered as a hydrofluoroalkane (HFA) pressurized metered dose inhaler, studied in adults with mild to moderate asthma. The HFA propellant replaces the older chlorofluorocarbon propellant in the inhaler device.

What does Budesonide HFA target?

Budesonide HFA targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. Binding and activating NR3C1 produces the anti-inflammatory effects expected from an inhaled corticosteroid in the airways of asthma patients.

Who makes Budesonide HFA?

Budesonide HFA is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the clinical development program for this inhaled asthma product.

What phase is Budesonide HFA in?

Budesonide HFA has been studied in Phase 3 clinical development. It is an investigational product and is not described as approved. The Phase 3 trial in the program has completed, and no active trials are currently listed for this asset.

What clinical trials is Budesonide HFA in?

Budesonide HFA was evaluated in the Phase 3 trial NCT00667992, titled a study comparing budesonide hydrofluoroalkane (HFA) versus chlorofluorocarbon (CFC) pressurized metered dose inhalers in patients with mild to moderate asthma. The trial enrolled 99 adults, was randomized and active controlled, and was conducted in the United States and the United Kingdom.