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Symbicort Rapihaler Therapeutic Equivalence Study (ESTHER)

Primary Purpose

Bronchial Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Symbicort Turbuhaler
Symbicort pMDI
Pulmicort Turbuhaler
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchial Asthma focused on measuring Asthma, Symbicort

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Symbicort pMDI

Symbicort Turbuhaler

Pulmicort Turbuhaler

Arm Description

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

Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
September 27, 2007
Last Updated
August 14, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00536731
Brief Title
Symbicort Rapihaler Therapeutic Equivalence Study
Acronym
ESTHER
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma
Keywords
Asthma, Symbicort

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
742 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symbicort pMDI
Arm Type
Active Comparator
Arm Description
Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Arm Title
Symbicort Turbuhaler
Arm Type
Active Comparator
Arm Description
Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Arm Title
Pulmicort Turbuhaler
Arm Type
Active Comparator
Arm Description
Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
Intervention Type
Drug
Intervention Name(s)
Symbicort Turbuhaler
Intervention Description
Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Intervention Type
Drug
Intervention Name(s)
Symbicort pMDI
Intervention Description
Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Intervention Type
Drug
Intervention Name(s)
Pulmicort Turbuhaler
Intervention Description
Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
Primary Outcome Measure Information:
Title
Morning Peak Expiratory Flow (PEF)
Description
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
Time Frame
Baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Evening Peak Expiratory Flow (PEF)
Description
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
Time Frame
Baseline to 6 weeks
Title
Asthma Symptom Score, Night
Description
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.
Time Frame
Baseline to 6 weeks
Title
Asthma Symptom Score, Day
Description
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.
Time Frame
Baseline to 6 weeks
Title
Asthma Symptom Score, Total
Description
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.
Time Frame
Baseline to 6 weeks
Title
Percentage of Nights With Awakenings Due to Asthma
Description
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.
Time Frame
Baseline and 6 weeks
Title
Use of Rescue Medication, Night
Description
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
Time Frame
Baseline to 6 weeks
Title
Use of Rescue Medication, Day
Description
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
Time Frame
Baseline to 6 weeks
Title
Use of Rescue Medication, Total
Description
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
Time Frame
Baseline to 6 weeks
Title
Percentage of Symptom-free Days
Description
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.
Time Frame
Baseline to 6 weeks
Title
Percentage of Asthma Control Days
Description
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.
Time Frame
Baseline to 6 weeks
Title
Percentage of Rescue Free Days
Description
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.
Time Frame
Baseline to 6 weeks
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Andersson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Akos Somoskovi
Organizational Affiliation
AstraZeneca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Rousse
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Varna
Country
Bulgaria
Facility Name
Research Site
City
Benesov U Prahy
Country
Czech Republic
Facility Name
Research Site
City
Hradec Kralove
Country
Czech Republic
Facility Name
Research Site
City
Jihlava
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Kolin
Country
Czech Republic
Facility Name
Research Site
City
Kutna Hora
Country
Czech Republic
Facility Name
Research Site
City
Litomerice
Country
Czech Republic
Facility Name
Research Site
City
Neratovice
Country
Czech Republic
Facility Name
Research Site
City
Pardubice
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
Country
Czech Republic
Facility Name
Research Site
City
Praha 5
Country
Czech Republic
Facility Name
Research Site
City
Praha 8
Country
Czech Republic
Facility Name
Research Site
City
Rokycany
Country
Czech Republic
Facility Name
Research Site
City
Strakonice
Country
Czech Republic
Facility Name
Research Site
City
Balassagyarmat
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Cegléd
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Deszk
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Gyula
Country
Hungary
Facility Name
Research Site
City
Kaposvar
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
Country
Hungary
Facility Name
Research Site
City
Szarvas
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Százhalombatta
Country
Hungary
Facility Name
Research Site
City
Törökbálint
Country
Hungary
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Bielsko-biala
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
Country
Poland
Facility Name
Research Site
City
Chodziez
Country
Poland
Facility Name
Research Site
City
Chrzanow
Country
Poland
Facility Name
Research Site
City
Karpacz
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Lomza
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Ostrow Wielkopolski
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Skierniewice
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Tarnow
Country
Poland
Facility Name
Research Site
City
Turek
Country
Poland
Facility Name
Research Site
City
Wodzislaw Slaski
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

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Symbicort Rapihaler Therapeutic Equivalence Study

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