Symbicort Rapihaler Therapeutic Equivalence Study

Condition(s) targeted: Bronchial Asthma

Intervention: Symbicort Turbuhaler (Drug); Symbicort pMDI (Drug); Pulmicort Turbuhaler (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tomas Andersson, Study Director, Affiliation: AstraZeneca
Akos Somoskovi, Principal Investigator, Affiliation: AstraZeneca

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.

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The primary objective is to show that Symbicort pMDI 40/2.25 μg two actuations b.i.d is more efficacious than Pulmicort Turbuhaler 100 μg one inhalation b.i.d. over a 6-week treatment period.

Secondary outcome: Secondary objectives are to compare the efficacy of Symbicort pMDI 40/2.25 μg two actuations b.i.d with that of Symbicort Turbuhaler 80/4.5 μg one inhalation b.i.d and to investigate the safety profile of Symbicort pMDI 40/2.25 μg two actuations b.i.d,

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Research Site, PLEVEN, Bulgaria

Research Site, PLOVDIV, Bulgaria

Research Site, RUSE, Bulgaria

Research Site, RUSSE, Bulgaria

Research Site, SOFIA, Bulgaria

Research Site, VARNA, Bulgaria

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 4, 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, BALASSAGYARMAT, Hungary

Research Site, BUDAPEST, Hungary

Research Site, CEGL�D, Hungary

Research Site, DEBRECEN, Hungary

Research Site, DESZK, Hungary

Research Site, GY?R, Hungary

Research Site, GYULA, Hungary

Research Site, KAPOSV�R, Hungary

Research Site, NY�REGYH�ZA, Hungary

Research Site, SZARVAS, Hungary

Research Site, SZ�ZHALOMBATTA, Hungary

Research Site, SZEGED, Hungary

Research Site, T�R�KB�LINT, Hungary

Research Site, BIA?YSTOK, Poland

Research Site, BIELSKO-BIA?A, Poland

Research Site, BYDGOSZCZ, Poland

Research Site, CHODZIE?, Poland

Research Site, CHRZAN�W, Poland

Research Site, KARPACZ, Poland

Research Site, KRAK�W, Poland

Research Site, LUBLIN, Poland

Research Site, ?�D?, Poland

Research Site, ?OM?A, Poland

Research Site, OSTR�W WIELKOPOLSKI, Poland

Research Site, POZNA?, Poland

Research Site, SKIERNIEWICE, Poland

Research Site, SZCZECIN, Poland

Research Site, TARN�W, Poland

Research Site, TUREK, Poland

Research Site, WODZIS?AW ?L?SKI, Poland

Research Site, WROC?AW, Poland

Starting date: September 2007
Last updated: April 15, 2008