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SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00238784
Enrollment
1300
Registered
2005-10-14
Start date
2004-05-31
Completion date
2005-10-31
Last updated
2008-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma

Interventions

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Time to first severe asthma exacerbation

Secondary

MeasureTime frame
Mean use of as-needed medication
Prescribed asthma medication
Patient reported Outcomes
Number of asthma exacerbations
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
Health care resource use

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026