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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00536913
First received: September 26, 2007
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Asthma
Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer
Drug: Budesonide/formoterol pMDI 40/2.25 ug
Phase 3

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Urinary Free Cortisol (UFC) [ Time Frame: At baseline and 4 weeks ] [ Designated as safety issue: No ]
    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:
  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: At baseline, at 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Daily during run-in and daily during treatment period of 6 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Daily during run-in and daily during treatment period of 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and daily during treatment period of 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and daily during treatment period of 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and daily during treatment period of 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and daily during treatment period of 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily during run-in and daily during treatment period of 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 107
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536913

Locations
Hungary
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Kaposvar, Hungary
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, Poland
Russian Federation
Research Site
Moscow, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tomas Anderson, MD PhD AstraZeneca
Principal Investigator: Piotr Kuna, MD PhD Uniwersytecki Spital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00536913     History of Changes
Other Study ID Numbers: D5897C00004
Study First Received: September 26, 2007
Results First Received: February 16, 2009
Last Updated: April 5, 2012
Health Authority: Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Russia: Ministry of Health and Social Welfare

Keywords provided by AstraZeneca:
Symbicort pMDI
spacer
children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014