New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day (BAI)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Symbicort; Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360021

D589OC00003

Details and patient eligibility

About

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

Enrollment: 214 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female 12 years and above
• Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
• Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
• Patients with reversible airway obstruction
• Documented daily use of inhaled corticosteroids for ≥ 3 months

Exclusion criteria

• History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
• Hospitalized during previous 6 months for asthma
• Required emergency treatment more than once during previous 6 months for an asthma-related condition
• Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
• Respiratory infection affecting the asthma within 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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214 participants in 3 patient groups

1 Symbicort/inhaler

Active Comparator group

Description:

Symbicort BA MDI 2x160/4.5 μg twice daily

Treatment:

Drug: Symbicort

Drug: Symbicort

Symbicort/inhaler

Active Comparator group

Description:

Symbicort AC pDMI 2x160/4.5 μg twice daily

Treatment:

Drug: Symbicort

Drug: Symbicort

Budesonide/inhaler

Active Comparator group

Description:

Budesonide AC pMDI 2x160 μg twice daily

Treatment:

Drug: Budesonide