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

Asthma Clinical Trial

— Spacer  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536913
• Other study ID #: D5897C00004
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2007
• Last updated: April 5, 2012
• Start date: September 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of PharmacyPoland: Ministry of HealthRussia: Ministry of Health and Social Welfare
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/formoterol pMDI 40/2.25ug + spacer

• Budesonide/formoterol pMDI 40/2.25 ug

Locations

Country	Name	City	State
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Kaposvar
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Bytom
Poland	Research Site	Karpacz
Poland	Research Site	Krakow
Poland	Research Site	Lodz
Poland	Research Site	Warszawa
Russian Federation	Research Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Hungary,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No