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

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ClinicalTrials.gov Identifier: NCT00536913
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : February 27, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Urinary Free Cortisol (UFC) [ Time Frame: 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 :
  1. Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: 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.

  2. Morning Peak Expiratory Flow (mPEF) [ Time Frame: 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.

  3. Evening Peak Expiratory Flow (ePEF) [ Time Frame: 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.

  4. Asthma Symptoms at Night [ Time Frame: 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.

  5. Asthma Symptoms at Day [ Time Frame: 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.

  6. Percentage of Nights With Awakenings Due to Asthma [ Time Frame: 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.

  7. Use of Rescue Medication at Night [ Time Frame: 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.

  8. Use of Rescue Medication at Day [ Time Frame: 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.



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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00536913     History of Changes
Other Study ID Numbers: D5897C00004
First Posted: September 28, 2007    Key Record Dates
Results First Posted: February 27, 2012
Last Update Posted: April 6, 2012
Last Verified: April 2012

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
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists