Symbicort Rapihaler Therapeutic Equivalence Study

Bronchial Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536731
• Other study ID #: D5897C00003
• Status: Completed
• Phase: Phase 3
• First received: September 27, 2007
• Last updated: August 14, 2012
• Start date: September 2007
• Est. completion date: April 2008

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy (OGYI)Poland: Office for Registration of Medicinal ProductsCzech Republic: State Institute for Drug ControlBulgaria: Bulgarian Drug Agency (BDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 742
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• Symbicort Turbuhaler
Symbicort Turbuhaler® 80/4.5 µg 1 Inhalation Twice Daily
• Symbicort pMDI
Symbicort®pMDI® 40/2.25 µg 2 Actuations Twice Daily
• Pulmicort Turbuhaler
Pulmicort®Turbuhaler® 100 µg 1 Inhalation Twice Daily

Locations

Country	Name	City	State
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Rousse
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Czech Republic	Research Site	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
Hungary	Research Site	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	Százhalombatta
Hungary	Research Site	Szeged
Hungary	Research Site	Törökbálint
Poland	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Hungary,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Baseline to 6 weeks	No
Secondary	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.	Baseline to 6 weeks	No
Secondary	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.	Baseline to 6 weeks	No
Secondary	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.	Baseline to 6 weeks	No
Secondary	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.	Baseline and 6 weeks	No
Secondary	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	Baseline to 6 weeks	No
Secondary	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	Baseline to 6 weeks	No
Secondary	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	Baseline to 6 weeks	No
Secondary	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.	Baseline to 6 weeks	No
Secondary	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.	Baseline to 6 weeks	No
Secondary	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.	Baseline to 6 weeks	No
Secondary	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)	Baseline to 6 weeks	No