Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
This study has been terminated.
Sponsor:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00385593
First Posted: October 9, 2006
Last Update Posted: December 16, 2010
Information provided by:
AstraZeneca
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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 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: 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 |
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 |
Eligibility
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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 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
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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Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Carlos Barcina, MD | AstraZeneca |
More Information
| ClinicalTrials.gov Identifier: | NCT00385593 History of Changes |
| Other Study ID Numbers: |
D5890L00010 2005-005974-64 SPAIN |
| First Submitted: | October 6, 2006 |
| First Posted: | October 9, 2006 |
| Results First Submitted: | October 14, 2009 |
| Results First Posted: | November 17, 2009 |
| Last Update Posted: | December 16, 2010 |
| Last Verified: | November 2010 |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Formoterol Fumarate Budesonide 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 Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |