A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg (CHASE 3)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Other: Budesonide pMDI; Drug: Symbicort pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT02091986

D589GC00003

Details and patient eligibility

About

The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma during 12 weeks.

Full description

A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma

Enrollment: 882 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has a documented clinical diagnosis of asthma defined by the ATS for at least 6 months prior to Visit 2
• Have a morning pre-bronchodilator clinic FEV1 measured at least 6 hours after the last dose of inhaled SABA and at least 48 hours after last dose of inhaled LABA of 60% to 100% of predicted normal
• Demonstrated reversibility of clinic FEV1 of ≥12% from pre -albuterol/salbutamol level within 15 to 30 minutes after administration of a standard dose of albuterol/salbutamol.

Exclusion criteria

• Have been hospitalized at least once or required emergency treatment more than once for an asthma-related condition during the 6 months prior to Visit 1
• Have required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 6 weeks prior to Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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882 participants in 3 patient groups

Symbicort pMDI 80/2.25 µg

Active Comparator group

Description:

Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily

Treatment:

Drug: Symbicort pMDI

Drug: Symbicort pMDI

Symbicort pMDI 80/4.5µg

Active Comparator group

Description:

Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily

Treatment:

Drug: Symbicort pMDI

Drug: Symbicort pMDI

Budesonide pMDI

Active Comparator group

Description:

Budesonide pMDI 80µg, 2 acuations twice daily

Treatment:

Other: Budesonide pMDI