SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00238784
First received: October 12, 2005
Last updated: January 11, 2008
Last verified: January 2008
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Purpose
The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Budesonide/formoterol Turbuhaler |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Time to first severe asthma exacerbation
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 1300 |
| Study Start Date: | May 2004 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238784
Please refer to this study by its ClinicalTrials.gov identifier: NCT00238784
Locations
| Canada, British Columbia | |
| Research Site | |
| Aldergrove, British Columbia, Canada | |
| Canada, Ontario | |
| Research Site | |
| Bolton, Ontario, Canada | |
| Research Site | |
| Brampton, Ontario, Canada | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Rita Medical Science Director, MD | AstraZeneca |
More Information
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 |
| Study First Received: | October 12, 2005 |
| Last Updated: | January 11, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide, Formoterol Fumarate Drug Combination Formoterol Fumarate Budesonide Anti-Asthmatic Agents Respiratory System Agents |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs 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 |
ClinicalTrials.gov processed this record on September 26, 2016