SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Budesonide/formoterol Turbuhaler (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Rita Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best
Conventional Practice in patients with persistent asthma
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Time to first severe asthma exacerbation
Secondary outcome: Number of asthma exacerbationsMean 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
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Research Site, Aldergrove, British Columbia, Canada
Research Site, Bolton, Ontario, Canada
Research Site, Brampton, Ontario, Canada
Additional Information
Starting date: May 2004
Ending date: October 2005
Last updated: January 11, 2008
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