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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: Symbicort pMDI
* Drug: Symbicort pMDI
* Other: Budesonide pMDI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Symbicort pMDI 80/2.25 µg<br>Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily | Drug: Symbicort pMDI<br>* Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily<br>|
| Active Comparator: Symbicort pMDI 80/4.5µg<br>Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily | Drug: Symbicort pMDI<br>* Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily<br>|
| Active Comparator: Budesonide pMDI<br>Budesonide pMDI 80µg, 2 acuations twice daily | Other: Budesonide pMDI<br>* Budesonide pMDI 80µg, 2 acuations twice daily<br>* Other names: Active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in 1h Post-dose FEV1 | 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). | Week 0 (baseline), Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 12 in 1h Post-dose PEF | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Week 12 in 1h Post-dose FEF25-75 | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Week 12 in 1h Post-dose FVC | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Week 12 in Pre-dose FEV1 | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Week 12 in Pre-dose PEF | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Week 12 in Pre-dose FEF25-75 | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Week 12 in Pre-dose FVC | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Week 12 in 15 Min Post-dose FEV1 | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to End of Study Average in Total Asthma Symptoms | 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 = Mild symptoms; awareness of asthma symptoms and/or signs that are easily tolerated = Moderate symptoms, asthma symptoms with some discomfort, causing some interference with daily activities or sleep = 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to End of Study Average in % of Night Time Awakenings Due to Asthma Symptoms | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to End of Study Average in Total Daily Reliever Medication | 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). | Week 0 (baseline), Week 12 | 
| Change From Baseline to Study Period Average in Overall PAQLQ Score | 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. | Week 0 (baseline), week 4, week 8, week 12 | 
| Number of Patients With an Asthma Exacerbation During Study | 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. | Week 0 (baseline) up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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asthma, children, budesonide pMDI