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Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
This study has been completed.
First Received: October 6, 2006   Last Updated: October 14, 2009   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00385593
  Purpose

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 GCS treatment or who require and are already on treatment with a combination of inhaled GCS and LABA.


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

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 mg, 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to First Severe Asthma Exacerbation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total Number of Severe Exacerbations [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean Use of as Needed Medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Use of Inhaled Steroids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in the Asthma Control Questionnaire(ACQ) Score [ Time Frame: Daily 14 days prior to each of visit 2-4 ] [ Designated as safety issue: No ]
  • Peak Expiratory Flow (PEF) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 791
Study Start Date: September 2006
Study Completion Date: October 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 long-acting b2-agonist(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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385593

  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carlos Barcina, MD AstraZeneca
  More Information

No publications provided

Study ID Numbers: D5890L00010, 2005-005974-64, SPAIN
Study First Received: October 6, 2006
Results First Received: October 14, 2009
Last Updated: October 14, 2009
ClinicalTrials.gov Identifier: NCT00385593     History of Changes
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Symbicort
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010