Clinical trial NCT00536731: Symbicort Rapihaler Therapeutic Equivalence Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchial Asthma
Keywords: Asthma
Symbicort
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-28
Enrollment: 742
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Morning Peak Expiratory Flow (PEF)
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Evening Peak Expiratory Flow (PEF)
timeFrame: Baseline to 6 weeks
measure: Asthma Symptom Score, Night
timeFrame: Baseline to 6 weeks
measure: Asthma Symptom Score, Day
timeFrame: Baseline to 6 weeks
measure: Asthma Symptom Score, Total
timeFrame: Baseline to 6 weeks
measure: Percentage of Nights With Awakenings Due to Asthma
timeFrame: Baseline and 6 weeks
measure: Use of Rescue Medication, Night
timeFrame: Baseline to 6 weeks
measure: Use of Rescue Medication, Day
timeFrame: Baseline to 6 weeks
measure: Use of Rescue Medication, Total
timeFrame: Baseline to 6 weeks
measure: Percentage of Symptom-free Days
timeFrame: Baseline to 6 weeks
measure: Percentage of Asthma Control Days
timeFrame: Baseline to 6 weeks
measure: Percentage of Rescue Free Days
timeFrame: Baseline to 6 weeks
measure: Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Rousse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Benesov U Prahy
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Jihlava
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Kolin
country: Czech Republic
facility: Research Site
city: Kutna Hora
country: Czech Republic
facility: Research Site
city: Litomerice
country: Czech Republic
facility: Research Site
city: Neratovice
country: Czech Republic
facility: Research Site
city: Pardubice
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Praha 5
country: Czech Republic
facility: Research Site
city: Praha 8
country: Czech Republic
facility: Research Site
city: Rokycany
country: Czech Republic
facility: Research Site
city: Strakonice
country: Czech Republic
facility: Research Site
city: Balassagyarmat
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Cegléd
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Kaposvar
country: Hungary
facility: Research Site
city: Nyíregyháza
country: Hungary
facility: Research Site
city: Szarvas
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Százhalombatta
country: Hungary
facility: Research Site
city: Törökbálint
country: Hungary
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bielsko-biala
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chodziez
country: Poland
facility: Research Site
city: Chrzanow
country: Poland
facility: Research Site
city: Karpacz
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lomza
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostrow Wielkopolski
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Tarnow
country: Poland
facility: Research Site
city: Turek
country: Poland
facility: Research Site
city: Wodzislaw Slaski
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tomas Andersson
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Akos Somoskovi
role: PRINCIPAL_INVESTIGATOR
References: