Symbicort Rapihaler Therapeutic Equivalence Study
ESTHER
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
1 other identifier
interventional
742
4 countries
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2007
Shorter than P25 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
September 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
August 15, 2012
CompletedAugust 15, 2012
August 1, 2012
7 months
September 27, 2007
April 1, 2009
August 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline to 6 weeks
Secondary Outcomes (12)
Evening Peak Expiratory Flow (PEF)
Baseline to 6 weeks
Asthma Symptom Score, Night
Baseline to 6 weeks
Asthma Symptom Score, Day
Baseline to 6 weeks
Asthma Symptom Score, Total
Baseline to 6 weeks
Percentage of Nights With Awakenings Due to Asthma
Baseline and 6 weeks
- +7 more secondary outcomes
Study Arms (3)
Symbicort pMDI
ACTIVE COMPARATORSymbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
Symbicort Turbuhaler
ACTIVE COMPARATORSymbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Pulmicort Turbuhaler
ACTIVE COMPARATORPulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
Interventions
Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (48)
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Benesov U Prahy, Czechia
Research Site
Hradec Králové, Czechia
Research Site
Jihlava, Czechia
Research Site
Kladno, Czechia
Research Site
Kolín, Czechia
Research Site
Kutná Hora, Czechia
Research Site
Litoměřice, Czechia
Research Site
Neratovice, Czechia
Research Site
Pardubice, Czechia
Research Site
Prague, Czechia
Research Site
Rokycany, Czechia
Research Site
Strakonice, Czechia
Research Site
Balassagyarmat, Hungary
Research Site
Budapest, Hungary
Research Site
Cegléd, Hungary
Research Site
Debrecen, Hungary
Research Site
Deszk, Hungary
Research Site
Győr, Hungary
Research Site
Gyula, Hungary
Research Site
Kaposvár, Hungary
Research Site
Nyíregyháza, Hungary
Research Site
Szarvas, Hungary
Research Site
Százhalombatta, Hungary
Research Site
Szeged, Hungary
Research Site
Törökbálint, Hungary
Research Site
Bialystok, Poland
Research Site
Bielsko-Biala, Poland
Research Site
Bydgoszcz, Poland
Research Site
Chodzież, Poland
Research Site
Chrzanów, Poland
Research Site
Karpacz, Poland
Research Site
Krakow, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Ostrów Wielkopolski, Poland
Research Site
Poznan, Poland
Research Site
Skierniewice, Poland
Research Site
Szczecin, Poland
Research Site
Tarnów, Poland
Research Site
Turek, Poland
Research Site
Wodzisław Śląski, Poland
Research Site
Wroclaw, Poland
Research Site
Łomża, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Tomas Andersson
AstraZeneca
- PRINCIPAL INVESTIGATOR
Akos Somoskovi
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2007
First Posted
September 28, 2007
Study Start
September 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
August 15, 2012
Results First Posted
August 15, 2012
Record last verified: 2012-08