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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
742

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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