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

This study has been terminated.
Information provided by:
AstraZeneca Identifier:
First received: October 6, 2006
Last updated: November 30, 2010
Last verified: November 2010
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).

Condition Intervention Phase
Asthma, Bronchial
Drug: Symbicort (budesonide/formoterol) Turbuhaler
Drug: Conventional treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to First Severe Asthma Exacerbation [ Time Frame: 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:
  • Total Number of Severe Exacerbations [ Time Frame: 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 [ Time Frame: Baseline up to 6 months ]
    Mean use of as needed medication during the treatment period

  • Use of Inhaled Steroids [ Time Frame: Baseline up to 6 months ]
    Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)

  • Change in the Asthma Control Questionnaire(ACQ) Score [ Time Frame: 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) [ Time Frame: 6 months (end of the study) ]
    Peak expiratory flow (PEF)

Enrollment: 654
Study Start Date: September 2006
Study Completion Date: October 2008

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00385593

  Show 52 Study Locations
Sponsors and Collaborators
Study Director: Carlos Barcina, MD AstraZeneca
  More Information Identifier: NCT00385593     History of Changes
Other Study ID Numbers: D5890L00010
Study First Received: October 6, 2006
Results First Received: October 14, 2009
Last Updated: November 30, 2010

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 23, 2017