SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
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ClinicalTrials.gov Identifier: NCT00238784 |
Recruitment Status
:
Completed
First Posted
: October 14, 2005
Last Update Posted
: January 14, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Budesonide/formoterol Turbuhaler | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 1300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Comparison of Symbicort® Single Inhaler Therapy (Symbicort® 200 Turbuhaler® 1 Inhalation b.i.d. Plus as Needed) & Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents & Adults-a 26-Week, Randomised, Open-Label, Parallel Group, Multicentre Study |
Study Start Date : | May 2004 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

- Time to first severe asthma exacerbation
- Number of asthma exacerbations
- Mean use of as-needed medication
- Prescribed asthma medication
- Patient reported Outcomes
- Health care resource use
- Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events
- Induced sputum will be sampled from a subset of patients
- All variables assessed over the 6 months treatment period

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of asthma < 3 months
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1
Exclusion Criteria:
- Smoking history > 10 pack-years
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
- Any significant disease or disorder that my jeopardize the safety of the patient.
Additional inclusion and exclusion criteria will be evaluated by the investigator.

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): NCT00238784
Canada, British Columbia | |
Research Site | |
Aldergrove, British Columbia, Canada | |
Canada, Ontario | |
Research Site | |
Bolton, Ontario, Canada | |
Research Site | |
Brampton, Ontario, Canada |
Study Director: | AstraZeneca Rita Medical Science Director, MD | AstraZeneca |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00238784 History of Changes |
Other Study ID Numbers: |
D5890L00004 SOLO |
First Posted: | October 14, 2005 Key Record Dates |
Last Update Posted: | January 14, 2008 |
Last Verified: | January 2008 |
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 |