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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Kaposvár, Hungary
Research Site
Bialystok, Poland
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
Time frame: At baseline and 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily during run-in and daily during treatment period of 6 weeks
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Research Site
Bydgoszcz, Poland
Research Site
Bytom, Poland
Research Site
Karpacz, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Warsaw, Poland
...and 1 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Daily during run-in and daily during treatment period of 6 weeks