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Completed

NCT Number: NCT00536731

Symbicort Rapihaler Therapeutic Equivalence Study

The purpose of the this study is to evaluate the efficacy and safety of 2 actuations Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Pleven, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Asthma clinically diagnosed since at least 6 months.
  • Lung function values measured ≥ 50% and ≤ 90% of predicted normal.
  • Patients with reversible airway obstruction Daily use of inhaled steroids (any brand) for >3 months.

Exclusion criteria

  • Use of oral, rectal or parenteral steroids within 30 days prior to start of study.
  • Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment.
  • Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.

Treatment and study plan

Symbicort Turbuhaler

Drug

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Symbicort pMDI

Drug

Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

Pulmicort Turbuhaler

Drug

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Primary outcomes

  1. Morning Peak Expiratory Flow (PEF)

    Time frame: Baseline to 6 weeks

    Change in the Morning PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed

Secondary outcomes

  1. Evening Peak Expiratory Flow (PEF)

    Time frame: Baseline to 6 weeks

    Change in the Evening PEF from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomisation). No imputation of missing data was performed

  2. Asthma Symptom Score, Night

    Time frame: Baseline to 6 weeks

    Change in the Asthma Symptom Score (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

  3. Asthma Symptom Score, Day

    Time frame: Baseline to 6 weeks

    Change in the Asthma Symptom Score (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

  4. Asthma Symptom Score, Total

    Time frame: Baseline to 6 weeks

    Change in the Asthma Symptom Score (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.

  5. Percentage of Nights With Awakenings Due to Asthma

    Time frame: Baseline and 6 weeks

    Change in the Percentage of Nights With Awakenings Due to Asthma from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. The participants answered "Yes" or "No" whether she/he woke up during the night due to asthma.

  6. Use of Rescue Medication, Night

    Time frame: Baseline to 6 weeks

    Change in the Use of Rescue Medication (Night) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed

  7. Use of Rescue Medication, Day

    Time frame: Baseline to 6 weeks

    Change in the Use of Rescue Medication (Day) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed

  8. Use of Rescue Medication, Total

    Time frame: Baseline to 6 weeks

    Change in the Use of Rescue Medication (Total) from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed

  9. Percentage of Symptom-free Days

    Time frame: Baseline to 6 weeks

    Change in the Percentage of Symptom-free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Symptom-free Day: no symptoms (asthma symptom score=0) night and day, and no awakenings due to asthma.

  10. Percentage of Asthma Control Days

    Time frame: Baseline to 6 weeks

    Change in the Percentage of Symptom Control Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Asthma Control Day: no symptoms (asthma symptom score=0) night and day, no awakenings due to asthma, no rescue medication.

  11. Percentage of Rescue Free Days

    Time frame: Baseline to 6 weeks

    Change in the Percentage of Rescue Free Days from baseline (calculated as a mean using all available data for the 10 last days of run-in period) to week 6 (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Rescue-free Day defined as day and night with no use of rescue medication.

  12. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline to 6 weeks

    Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A 6-week, Phase III, Double-blind, Randomized, Multi-centre, Parallel-group Study Evaluating the Efficacy and Safety of 2 Actuations Symbicort®pMDI® 40/2.25 μg Twice Daily Compared With 1 Inhalation Symbicort Turbuhaler® 80/4.5 μg Twice Daily and 1 Inhalation Pulmicort®Turbuhaler® 100 μg Twice Daily

Acronym: ESTHER

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 28, 2007
Registry last updated
Aug 15, 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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