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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 26, 2007
First Posted Date  ICMJE September 28, 2007
Results First Submitted Date  ICMJE February 16, 2009
Results First Posted Date  ICMJE February 27, 2012
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
The primary outcome variable will be 24-hour urinary free cortisol (UFC) excretion at the end of the treatment period
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2007)
Efficacy variables will be spirometry measurements at clinic visits, morning & evening Peak Expiratory Flow (PEF), asthma symptoms, night-time awakenings due to asthma & use of reliever medication recorded in daily diary.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer
  • Drug: Budesonide/formoterol pMDI 40/2.25 ug
Study Arms  ICMJE
  • Experimental: With Spacer
    Budesonide/formoterol pMDI 40/2.25ug + spacer
    Intervention: Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer
  • Experimental: Without Spacer
    Budesonide/formoterol pMDI 40/2.25 ug
    Intervention: Drug: Budesonide/formoterol pMDI 40/2.25 ug
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2012)
107
Original Estimated Enrollment  ICMJE
 (submitted: September 27, 2007)
100
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Poland,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00536913
Other Study ID Numbers  ICMJE D5897C00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tomas Anderson, MD PhD AstraZeneca
Principal Investigator: Piotr Kuna, MD PhD Uniwersytecki Spital
PRS Account AstraZeneca
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP