A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244608
• Other study ID #: D5890C00003
• Secondary ID: EudraCT no. 2004
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2005
• Last updated: January 21, 2011
• Start date: May 2005
• Est. completion date: March 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/Formoterol Turbuhaler

• Budesonide Turbuhaler (Pulmicort)

• Terbutaline Turbuhaler

Locations

Country	Name	City	State
Denmark	Research Site	Ålborg
Denmark	Research Site	Århus C
Denmark	Research Site	Copenhagen
France	Research Site	Montpellier
France	Research Site	Pessac
Germany	Research Site	Hannover
Germany	Research Site	Mainz
Germany	Research Site	Marburg
Spain	Research Site	Baraclado
Spain	Research Site	Barcelona No. 40
Spain	Research Site	Barcelona, No. 42
Sweden	Research Site	Göteborg
Sweden	Research Site	Lund
Sweden	Research Site	Stockholm
Sweden	Research Site	Umeå
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Newcastle-Upon-Tyne
United Kingdom	Research Site	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
Secondary	Immunopathology and remodeling in biopsies
Secondary	Immunopathology and mediators in induced sputum
Secondary	Severe asthma exacerbations (number of and time to first)
Secondary	Forced expiratory volume in 1 second (FEV1)
Secondary	As-needed use
Secondary	Safety variables, including adverse events and vital signs
Secondary	All variables assessed over the 12-month treatment period