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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 12, 2005
Last updated: January 11, 2008
Last verified: January 2008
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
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

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)

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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.

  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 identifier: NCT00238784

Canada, British Columbia
Research Site
Aldergrove, British Columbia, Canada
Canada, Ontario
Research Site
Bolton, Ontario, Canada
Research Site
Brampton, Ontario, Canada
Sponsors and Collaborators
Study Director: AstraZeneca Rita Medical Science Director, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): 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:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases processed this record on May 26, 2016