Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg

Overview

The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.

Full Title of Study: “Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed – a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).”

Study Type

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

Interventions

  • Drug: Budesonide/formoterol Turbuhaler
  • Drug: Salmeterol/fluticasone Diskus

Clinical Trial Outcome Measures

Primary Measures

  • Time to first severe asthma exacerbation

Secondary Measures

  • Number of severe asthma exacerbations
  • Mild asthma exacerbations
  • FEV1
  • Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries
  • Healthcare utilization
  • Safety (adverse events)
  • – all variables assessed over the 6 months treatment period

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosed with asthma since at least 6 months prior to first visit – Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit – At least one asthma exacerbation more than one but less than twelve months prior to first visit Exclusion Criteria:

  • Respiratory infection affecting asthma within 30 days before first visit – Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit – Any significant disease or disorder that may jeopardize the safety of the patient Additional inclusion and exclusion criteria will be evaluated by the Investigator.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

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.