A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: beta-II-agonist, inhale steroid; Drug: Symbicort TBH - Turbuhaler

• Registration Number: NCT00628758
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-03-05
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2009-09-18
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-06
• Last Update Submitted: 2012-07-06
• Results First Posted: 2012-08-14
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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 glucocorticosteroid (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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional BP	beta-II-agonist, inhale steroid	Conventional Best Practice for Treatment of Asthma
Symbicort	Symbicort TBH - Turbuhaler	Symbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)

Primary Outcome Measures

Name	Time	Method
Time to First Severe Asthma Exacerbation	26 weeks	Time to severe exacerbation among patients

Secondary Outcome Measures

Name	Time	Method
Number of Severe Asthma Exacerbations	26 weeks	Total number of severe asthma exacerbations per treatment group
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score	Baseline and 26 weeks	Quality-of-Life assessment; grouped in four domains;activity limitation, symptoms, emotional function and exposure to environmental stimuli, using with a scale from 1 to 7 where 1 represents the greatest possible impairment and 7 represents the least impairment.
Mean Use of As-needed Medication Per Day During Treatment Period	Daily recording during the treatment period of 26 weeks	Mean use of as-needed medication per day during treatment period

Trial Locations

Locations (1)

Research Site; 🇹🇷 Zonguldak, Turkey