Symbicort Rapihaler Therapeutic Equivalence Study (ESTHER)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Bronchial Asthma

Treatments: Drug: Pulmicort Turbuhaler; Drug: Symbicort pMDI; Drug: Symbicort Turbuhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT00536731

D5897C00003

Details and patient eligibility

About

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

Enrollment: 742 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asthma clinically diagnosed since at least 6 months.
• Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
• Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.

Exclusion criteria

• Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
• Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.
• Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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742 participants in 3 patient groups

Symbicort pMDI

Active Comparator group

Description:

Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

Treatment:

Drug: Symbicort pMDI

Symbicort Turbuhaler

Active Comparator group

Description:

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Treatment:

Drug: Symbicort Turbuhaler

Pulmicort Turbuhaler

Active Comparator group

Description:

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Treatment:

Drug: Pulmicort Turbuhaler