Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma

Study Overview
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Brief Summary
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The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Official Title
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A 4-week, Open-label, Randomized, Multi-centre, Parallel-group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer
* Drug: Budesonide/formoterol pMDI 40/2.25 ug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children 6-11 years, diagnosed asthma treated 6 months, PEF 50% of predicted normal value pre-bronchodilator Exclusion Criteria: current systemic glucocorticosteroids usage current respiratory infection any significant disease or disorder as judged by investigator

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With Spacer<br>Budesonide/formoterol pMDI 40/2.25ug + spacer | Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer<br> <br> |
| Experimental: Without Spacer<br>Budesonide/formoterol pMDI 40/2.25 ug | Drug: Budesonide/formoterol pMDI 40/2.25 ug<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Free Cortisol (UFC) | Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment | At baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in 1 Second (FEV1) | Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate. | At baseline, at 2 weeks and 4 weeks | 
| Morning Peak Expiratory Flow (mPEF) | Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation. | Daily during run-in and daily during treatment period of 6 weeks | 
| Evening Peak Expiratory Flow (ePEF) | Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation. | Daily during run-in and daily during treatment period of 6 weeks | 
| Asthma Symptoms at Night | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms. | Daily during run-in and daily during treatment period of 6 weeks | 
| Asthma Symptoms at Day | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms. | Daily during run-in and daily during treatment period of 6 weeks | 
| Percentage of Nights With Awakenings Due to Asthma | Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. | Daily during run-in and daily during treatment period of 6 weeks | 
| Use of Rescue Medication at Night | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. | Daily during run-in and daily during treatment period of 6 weeks | 
| Use of Rescue Medication at Day | Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. | Daily during run-in and daily during treatment period of 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symbicort pMDI, spacer, children