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

Phase 3

Completed

Conditions: Asthma

Interventions: Drug: Symbicort pMDI
Other: Budesonide pMDI

Registration Number: NCT02091986

Lead Sponsor: AstraZeneca

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 882

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symbicort pMDI 80/2.25 µg	Symbicort pMDI	Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
Symbicort pMDI 80/4.5µg	Symbicort pMDI	Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
Budesonide pMDI	Budesonide pMDI	Budesonide pMDI 80µg, 2 acuations twice daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in 1h Post-dose FEV1	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 Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in 1h Post-dose FVC	Week 0 (baseline), Week 12	1h post-dose FVC 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).
Change From Baseline to Week 12 in Pre-dose PEF	Week 0 (baseline), Week 12	Pre-dose PEF is defined as the pre-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).
Change From Baseline to Week 12 in 1h Post-dose PEF	Week 0 (baseline), Week 12	1h post-dose PEF 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).
Change From Baseline to Week 12 in 1h Post-dose FEF25-75	Week 0 (baseline), Week 12	1h post-dose FEF25-75 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).
Change From Baseline to Week 12 in Pre-dose FEV1	Week 0 (baseline), Week 12	Pre-dose FEV1 is defined as the pre-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).
Change From Baseline to Week 12 in Pre-dose FEF25-75	Week 0 (baseline), Week 12	Pre-dose FEF25-75 is defined as the pre-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).
Change From Baseline to Week 12 in Pre-dose FVC	Week 0 (baseline), Week 12	Pre-dose FVC is defined as the pre-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).
Change From Baseline to Week 12 in 15 Min Post-dose FEV1	Week 0 (baseline), Week 12	15 min Post-dose FEV1 is defined as the 15 min 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).
Change From Baseline to End of Study Average in Total Asthma Symptoms	Week 0 (baseline), Week 12	End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). Patient to record his/her asthma symptom score twice daily. The following rating scales are to be used: 0 = None; no symptoms of asthma 1. = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated 2. = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep 3. = Severe symptoms; incapacitating asthma symptoms and/or signs, with inability to perform daily activities or to sleep Total asthma symptom score is derived as the sum of the daytime score plus the score from the previous nighttime, ie possible range (0 to 6).
Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms	Week 0 (baseline), Week 12	End of study average is defined as the percentage of nighttime awakenings due to asthma symptoms from 6 days before up to and additionally including the morning of withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Change From Baseline to End of Study Average in Total Daily Reliever Medication	Week 0 (baseline), Week 12	End of study average is defined as the average of available records from 7 days before up to and including the day prior to withdrawal from study or Week 12, minus the baseline measurement at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued).
Change From Baseline to Study Period Average in Overall PAQLQ Score	Week 0 (baseline), week 4, week 8, week 12	Study period average is defined as the average of the post-baseline values during the study taken after first dose of investigational product up to and including withdrawal from study or Week 12, minus the baseline assessment at randomization, for patients who remain in the study (irrespective of whether IP has been discontinued). The PAQLQ(S) is a 23-item patient-reported questionnaire, each one reported on a 7-point scale (e.g. 1 = extremely bothered/all of the time; 7 = not bothered/none of the time). The PAQLQ(S) generates an overall score, as well as 3 domain scores: activity limitations (5 items), symptoms (10 items) and emotional function (8 items). The overall score will be calculated as the mean of the responses to each of the 23 questions (ie the range of 1-7, where higher scores indicate better quality of life). If any of the domain scores are missing, no total score will be calculated.
Number of Patients With an Asthma Exacerbation During Study	Week 0 (baseline) up to Week 12	Number of patients that experienced an asthma exacerbation that required either emergency room treatment, hospitalization, systemic steroids, or an increase in, or additional asthma maintenance medication, during the study.