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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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 |
Actual Study Completion Date : | October 2008 |

- 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.
- 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)

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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.

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

Study Director: | Carlos Barcina, MD | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00385593 History of Changes |
Other Study ID Numbers: |
D5890L00010 2005-005974-64 SPAIN |
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:
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 |