Symbicort Rapihaler Therapeutic Equivalence Study (ESTHER)

August 14, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

742

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Rousse, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Czech Republic
      • Benesov U Prahy, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Jihlava, Czech Republic
        • Research Site
      • Kladno, Czech Republic
        • Research Site
      • Kolin, Czech Republic
        • Research Site
      • Kutna Hora, Czech Republic
        • Research Site
      • Litomerice, Czech Republic
        • Research Site
      • Neratovice, Czech Republic
        • Research Site
      • Pardubice, Czech Republic
        • Research Site
      • Praha 4, Czech Republic
        • Research Site
      • Praha 5, Czech Republic
        • Research Site
      • Praha 8, Czech Republic
        • Research Site
      • Rokycany, Czech Republic
        • Research Site
      • Strakonice, Czech Republic
        • Research Site
  • Hungary
      • Balassagyarmat, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Cegléd, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Deszk, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Kaposvar, Hungary
        • Research Site
      • Nyíregyháza, Hungary
        • Research Site
      • Szarvas, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Százhalombatta, Hungary
        • Research Site
      • Törökbálint, Hungary
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Bielsko-biala, Poland
        • Research Site
      • Bydgoszcz, Poland
        • Research Site
      • Chodziez, Poland
        • Research Site
      • Chrzanow, Poland
        • Research Site
      • Karpacz, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lomza, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • Ostrow Wielkopolski, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Skierniewice, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Tarnow, Poland
        • Research Site
      • Turek, Poland
        • Research Site
      • Wodzislaw Slaski, Poland
        • Research Site
      • Wroclaw, Poland
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline and 6 weeks
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
Baseline to 6 weeks
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
Baseline to 6 weeks
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
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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.
Baseline to 6 weeks
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)
Baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Tomas Andersson, AstraZeneca
  • Principal Investigator: Akos Somoskovi, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 27, 2007

First Posted (Estimate)

September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5897C00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchial Asthma

Clinical Trials on Symbicort pMDI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe