Official Title: “A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5mg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults a -26-Week, Randomized, Open-Label, Parallel-Group, Multicentre Study”

The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adult patients with persistent asthma.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

A secondary objective is to collect safety data for treatment wtih Symbicort Single inhaler Therapy in adult patients with persistent asthma.

Intervention(s) in this Clinical Trial

• Drug: Symbicort TBH
• Drug: beta-II-agonist, inhale steroid
  • Salbulin inh. 200-400 dosage 100 mcg/dosage Salbutam SR caps 4 mg/8 mg Salbutol tb 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb,syrup, IV (5mg x10amp) Ventolin inh 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
• Behavioral: (AQLQ) diary for patients
• Device: Vitalograph peak flow meter
  • Model 4300 EN 13826 Cap no: 43600

Primary Measures

• Time to first severe asthma exacerbation. Defined deterioration in asthma leading to at least one of the following:1.Hospitalisation/Emergency room (or equivalent) treatment due to asthma 2.Oral GC treatment due to asthma for at least 3 days

Secondary Measures

• Number of severe asthma exacerbations
• Change in AQLQ(S) score from randomisation (visit 1) to Visits 4
• Mean use of as-needed medication per day during treatment period
• Prescribed asthma medication during the treatment period

Inclusion Criteria:

• Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required.
• Ability to read and write in Turkish
• Female or male outpatients aged 18 years
• Minimum of 3 months history of asthma, diagnosed according to the American Thoracic
• Society (ATS) definition
• Prescribed inhaled GCS at a dose of 320mg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1
• Either: daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA) or daily treatment with inhaled GCS alone (i.e. without LABA); and a history of suboptimal asthma control the month prior to enrollment as judged by the investigator;
• and use of 3 Peak Expiratory Flow inhalations ofas needed medication for symptom relief during the last 7 days before enrollment

Exclusion Criteria:

• Previous treatment with Symbicort Single inhaler Therapy
• Use of any b-blocking agent, including eye drops
• Use of oral GCS as maintenance treatment
• Known or suspected hypersensitivity to study therapy or excipients
• A history of smoking 10 pack years
• Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
• Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Zeynep Misirligil Principal Investigator Ankara Univ. Med. Fac, Chest Disease Dept  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00628758

Study ID Number: D5890L00016

ClinicalTrials.gov Identifier: NCT00628758

Health Authority: Turkey: Ministry of Health