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Completed

NCT Number: NCT00536913

Evaluation of Safety and Efficacy of Symbicort® pMDI, With or 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).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide/formoterol pMDI 40/2.25ug + spacer

Drug

Budesonide/formoterol pMDI 40/2.25 ug

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: Spacer

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 28, 2007
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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