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

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ClinicalTrials.gov Identifier: NCT00385593
Recruitment Status : Terminated
First Posted : October 9, 2006
Results First Posted : November 17, 2009
Last Update Posted : December 16, 2010
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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).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 654 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2006
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Mean Use of as Needed Medication [ Time Frame: Baseline up to 6 months ]
    Mean use of as needed medication during the treatment period

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

  4. 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)

  5. Peak Expiratory Flow (PEF) [ Time Frame: 6 months (end of the study) ]
    Peak expiratory flow (PEF)

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385593

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Research Site
A Coruna, Spain
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Alagon, Spain
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Alicante, Spain
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Almoradi, Spain
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Barcelona, Spain
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Burgos, Spain
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Cadiz, Spain
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Caravaca, Spain
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Cartagena, Spain
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Cordoba, Spain
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Coslada, Spain
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Dos Hermanas, Spain
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Elche, Spain
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Fuencarral, Spain
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Fuenlabrada, Spain
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Galdacano, Spain
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Gallur, Spain
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Gandia, Spain
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Getafe, Spain
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Gijon, Spain
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Granada, Spain
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Huelva, Spain
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Huesca, Spain
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Idiazabal, Spain
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Jaen, Spain
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Lugo, Spain
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Madrid, Spain
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Malaga, Spain
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Mataro, Spain
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Oviedo, Spain
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Pamplona, Spain
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Pinto, Spain
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Pozuelo de Alarcon, Spain
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Sagunto, Spain
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Salamanca, Spain
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San Juan, Spain
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San Sebastian, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Santiago, Spain
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Sevilla, Spain
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Terrassa, Spain
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Valdemoro, Spain
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Valencia, Spain
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Valladolid, Spain
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Vigo, Spain
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Viladecans, Spain
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Vilanova, Spain
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Villabona, Spain
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Villanueva de la Canada, Spain
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Vitoria, Spain
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Zaragoza, Spain
Sponsors and Collaborators
Study Director: Carlos Barcina, MD AstraZeneca

ClinicalTrials.gov Identifier: NCT00385593     History of Changes
Other Study ID Numbers: D5890L00010
First Posted: October 9, 2006    Key Record Dates
Results First Posted: November 17, 2009
Last Update Posted: December 16, 2010
Last Verified: November 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
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists