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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02091986
• Date of registration: 18/03/2014
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: 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
• Scientific title: 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
• Date of first enrolment: April 2014
• Target sample size: 882
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02091986
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Mexico, Panama, Slovakia, United States

Contacts

• Name: Carin Jorup, MD
• Affiliation: AstraZeneca Mölndal, Sweden

• Name: David S Pearlman, MD
• Affiliation: Colorado Allergy Asthma Centers, PC, US

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Symbicort pMDI

Other: Budesonide pMDI

Primary Outcome(s)

Change From Baseline to Week 12 in 1h Post-dose FEV1 [Time Frame: Week 0 (baseline), Week 12]

Secondary Outcome(s)

Number of Patients With an Asthma Exacerbation During Study [Time Frame: Week 0 (baseline) up to Week 12]

Change From Baseline to Week 12 in Pre-dose FEF25-75 [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to Week 12 in Pre-dose FVC [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to End of Study Average in Total Daily Reliever Medication [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to Study Period Average in Overall PAQLQ Score [Time Frame: Week 0 (baseline), week 4, week 8, week 12]

Change From Baseline to Week 12 in 1h Post-dose PEF [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to Week 12 in Pre-dose PEF [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to Week 12 in 15 Min Post-dose FEV1 [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to Week 12 in Pre-dose FEV1 [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to End of Study Average in Total Asthma Symptoms [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to Week 12 in 1h Post-dose FVC [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms [Time Frame: Week 0 (baseline), Week 12]

Change From Baseline to Week 12 in 1h Post-dose FEF25-75 [Time Frame: Week 0 (baseline), Week 12]

Secondary ID(s)

D589GC00003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/04/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02091986