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
Overview
- Phase
- Phase 3
- Intervention
- Symbicort pMDI
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 882
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Week 12 in 1h Post-dose FEV1
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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
Investigators
Eligibility Criteria
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
Arms & Interventions
Symbicort pMDI 80/2.25 µg
Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Intervention: Symbicort pMDI
Symbicort pMDI 80/4.5µg
Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Intervention: Symbicort pMDI
Budesonide pMDI
Budesonide pMDI 80µg, 2 acuations twice daily
Intervention: Budesonide pMDI
Outcomes
Primary Outcomes
Change From Baseline to Week 12 in 1h Post-dose FEV1
Time Frame: Week 0 (baseline), Week 12
1h post-dose FEV1 is defined as the 1-hour post-dose measurement taken at Week 12 minus the pre dose measurement taken at randomization for patients who remain in the study (irrespective of whether IP has been discontinued).
Secondary Outcomes
- Change From Baseline to Week 12 in 1h Post-dose FVC(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose PEF(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in 1h Post-dose PEF(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in 1h Post-dose FEF25-75(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose FEV1(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose FEF25-75(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in Pre-dose FVC(Week 0 (baseline), Week 12)
- Change From Baseline to Week 12 in 15 Min Post-dose FEV1(Week 0 (baseline), Week 12)
- Change From Baseline to End of Study Average in Total Asthma Symptoms(Week 0 (baseline), Week 12)
- Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms(Week 0 (baseline), Week 12)
- Change From Baseline to End of Study Average in Total Daily Reliever Medication(Week 0 (baseline), Week 12)
- Change From Baseline to Study Period Average in Overall PAQLQ Score(Week 0 (baseline), week 4, week 8, week 12)
- Number of Patients With an Asthma Exacerbation During Study(Week 0 (baseline) up to Week 12)