Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

Phase 3

Terminated

• Conditions: Asthma, Bronchial

• Registration Number: NCT00385593
• Lead Sponsor: AstraZeneca

Brief Summary

This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-06
• Study First Submitted QC: 2006-10-06
• Study First Posted: 2006-10-09
• Study Completion: 2008-10
• Results First Submitted: 2009-10-14
• Results First Submitted QC: 2009-10-14
• Results First Posted: 2009-11-17
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 654

Inclusion Criteria

• Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
• Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)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 LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
• A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
• Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment

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Exclusion Criteria

• Previous treatment with Symbicort Single Inhaler;
• Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
• Known or suspected hypersensitivity to study therapy or excipients.
• A history of smoking ≥ 10 pack years.
• Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to First Severe Asthma Exacerbation	Baseline up to 6 months	Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.

Secondary Outcome Measures

Name	Time	Method
Total Number of Severe Exacerbations	Baseline up to 6 months	Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.
Mean Use of as Needed Medication	Baseline up to 6 months	Mean use of as needed medication during the treatment period
Use of Inhaled Steroids	Baseline up to 6 months	Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Change in the Asthma Control Questionnaire(ACQ) Score	Daily 14 days prior to each of visit 2-4	The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Peak Expiratory Flow (PEF)	6 months (end of the study)	Peak expiratory flow (PEF)

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain