Symbicort Rapihaler Therapeutic Equivalence Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bronchial Asthma	Drug: Symbicort Turbuhaler Drug: Symbicort pMDI Drug: Pulmicort Turbuhaler	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Morning Peak Expiratory Flow (PEF) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: Baseline to 6 weeks ] [ Designated as safety issue: No ]
Change in the FEV1from baseline to week 6 (calculated as a mean using all available data after randomization)

Enrollment:	742
Study Start Date:	September 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536731

Show 50 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00536731 History of Changes
Other Study ID Numbers:	D5897C00003
Study First Received:	September 27, 2007
Results First Received:	April 1, 2009
Last Updated:	August 14, 2012
Health Authority:	Hungary: National Institute of Pharmacy (OGYI) Poland: Office for Registration of Medicinal Products Czech Republic: State Institute for Drug Control Bulgaria: Bulgarian Drug Agency (BDA)

Keywords provided by AstraZeneca:

Asthma
Symbicort

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Symbicort
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 16, 2013

Symbicort Rapihaler Therapeutic Equivalence Study (ESTHER)