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

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

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 Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer; Drug: Budesonide/formoterol pMDI 40/2.25 ug

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 3

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary
    • Research Site
  • Debrecen, Hungary
    • Research Site
  • Kaposvar, Hungary
    • Research Site
• Poland
  • 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, Poland
    • Research Site
• Russian Federation
  • Moscow, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With Spacer; Budesonide/formoterol pMDI 40/2.25ug + spacer	Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer
Experimental: Without Spacer; Budesonide/formoterol pMDI 40/2.25 ug	Drug: Budesonide/formoterol pMDI 40/2.25 ug

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Tomas Anderson, MD PhD, AstraZeneca; Principal Investigator: Piotr Kuna, MD PhD, Uniwersytecki Spital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: September 26, 2007
• First Submitted That Met QC Criteria: September 27, 2007
• First Posted (Estimate): September 28, 2007

Study Record Updates

• Last Update Posted (Estimate): April 6, 2012
• Last Update Submitted That Met QC Criteria: April 5, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: children; spacer; Symbicort pMDI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D5897C00004