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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer; Drug: Budesonide/formoterol pMDI 40/2.25 ug

• Registration Number: NCT00536913
• Lead Sponsor: AstraZeneca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-09-28
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-02-16
• Results First Submitted QC: 2012-01-23
• Results First Posted: 2012-02-27
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• children 6-11 years, diagnosed asthma treated
• 6 months, PEF
• 50% of predicted normal value pre-bronchodilator

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Exclusion Criteria

• current systemic glucocorticosteroids usage
• current respiratory infection
• any significant disease or disorder as judged by investigator

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Spacer	Budesonide/formoterol pMDI 40/2.25ug + spacer	Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer	Budesonide/formoterol pMDI 40/2.25 ug	Budesonide/formoterol pMDI 40/2.25 ug

Primary Outcome Measures

Name	Time	Method
Urinary Free Cortisol (UFC)	At baseline and 4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 Second (FEV1)	At baseline, at 2 weeks and 4 weeks	Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.
Morning Peak Expiratory Flow (mPEF)	Daily during run-in and daily during treatment period of 6 weeks	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.
Evening Peak Expiratory Flow (ePEF)	Daily during run-in and daily during treatment period of 6 weeks	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.
Asthma Symptoms at Night	Daily during run-in and daily during treatment period of 6 weeks	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.
Asthma Symptoms at Day	Daily during run-in and daily during treatment period of 6 weeks	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.
Percentage of Nights With Awakenings Due to Asthma	Daily during run-in and daily during treatment period of 6 weeks	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.
Use of Rescue Medication at Night	Daily during run-in and daily during treatment period of 6 weeks	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.
Use of Rescue Medication at Day	Daily during run-in and daily during treatment period of 6 weeks	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.

Trial Locations

Locations (1)

Research Site; 🇷🇺 Moscow, Russian Federation