Symbicort Rapihaler Therapeutic Equivalence Study (ESTHER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00536731
First received: September 27, 2007
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Bronchial Asthma
Drug: Symbicort Turbuhaler
Drug: Symbicort pMDI
Drug: Pulmicort Turbuhaler
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Morning Peak Expiratory Flow (PEF) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Evening Peak Expiratory Flow (PEF) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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

  • Asthma Symptom Score, Night [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Asthma Symptom Score, Day [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Asthma Symptom Score, Total [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Nights With Awakenings Due to Asthma [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Use of Rescue Medication, Night [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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

  • Use of Rescue Medication, Day [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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

  • Use of Rescue Medication, Total [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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

  • Percentage of Symptom-free Days [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Asthma Control Days [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Percentage of Rescue Free Days [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
    Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)


Enrollment: 742
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Symbicort pMDI
Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Drug: Symbicort pMDI
Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Active Comparator: Symbicort Turbuhaler
Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Drug: Symbicort Turbuhaler
Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Active Comparator: Pulmicort Turbuhaler
Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
Drug: Pulmicort Turbuhaler
Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536731

  Show 50 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tomas Andersson AstraZeneca
Principal Investigator: Akos Somoskovi AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00536731     History of Changes
Other Study ID Numbers: D5897C00003
Study First Received: September 27, 2007
Results First Received: April 1, 2009
Last Updated: August 14, 2012
Health Authority: Hungary: National Institute of Pharmacy (OGYI)
Poland: Office for Registration of Medicinal Products
Czech Republic: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency (BDA)

Keywords provided by AstraZeneca:
Asthma
Symbicort

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Symbicort
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014