Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide CFC; Drug: Budesonide HFA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667992

D5252C00008

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
• Currently a smoker or who has ceased smoking within 6 months of Visit 1.
• Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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99 participants in 4 patient groups

Budesonide Hydrofluoroalkane (HFA) 100

Active Comparator group

Description:

Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks

Treatment:

Drug: Budesonide HFA

Budesonide HFA 400

Active Comparator group

Description:

Budesonide HFA 400 mcg twice daily for 2 weeks

Treatment:

Drug: Budesonide HFA

Budesonide Chlorofluorocarbon (CFC) 100

Active Comparator group

Description:

Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks

Treatment:

Drug: Budesonide CFC

Budesonide CFC 400

Active Comparator group

Description:

Budesonide CFC 400 mcg twice daily for 2 weeks

Treatment:

Drug: Budesonide CFC