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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Budesonide/Formoterol Turbuhaler
  • Drug: Budesonide Turbuhaler (Pulmicort)
  • Drug: Terbutaline Turbuhaler

Clinical Trial Outcome Measures

Primary Measures

  • Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)

Secondary Measures

  • Immunopathology and remodeling in biopsies
  • Immunopathology and mediators in induced sputum
  • Severe asthma exacerbations (number of and time to first)
  • Forced expiratory volume in 1 second (FEV1)
  • As-needed use
  • Safety variables, including adverse events and vital signs
  • All variables assessed over the 12-month treatment period

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Overall Official(s)
    • AstraZeneca Symbicort Medical Science Director, MD, Study Director, AstraZeneca

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.