Clinical trial NCT00244608: A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
Official title: A Comparison of the Inflammatory Control of Asthma Provided by One Inhalation of Symbicort® Turbuhaler® 160/4.5 µg/Inhalation b.i.d. Plus As-needed Versus One Inhalation of Symbicort® Turbuhaler® 320/9 µg/Inhalation b.i.d. + One Inhalation of Pulmicort® Turbuhaler® 400 µg/Dose b.i.d. Plus Terbutaline Turbuhaler® 0.4 mg/Inhalation As-needed. A 12-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational, Phase IIIB Study in Adult Patients With Asthma, EOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma for at least 6 months
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one

Exclusion Criteria:

* Respiratory infection affecting asthma within 30 days prior to study
* Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study
* Any significant disease or disorder that may jeopardize the safety of the patient

Primary outcomes:
measure: Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
Secondary outcomes:
measure: Immunopathology and remodeling in biopsies
measure: Immunopathology and mediators in induced sputum
measure: Severe asthma exacerbations (number of and time to first)
measure: Forced expiratory volume in 1 second (FEV1)
measure: As-needed use
measure: Safety variables, including adverse events and vital signs
measure: All variables assessed over the 12-month treatment period
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Site
city: Ålborg
country: Denmark
facility: Research Site
city: Århus C
country: Denmark
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Baraclado
country: Spain
facility: Research Site
city: Barcelona No. 40
country: Spain
facility: Research Site
city: Barcelona, No. 42
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Research Site
city: Southampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References: