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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
Sponsor:
Information provided by:
AstraZeneca

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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources




Primary Outcome Measures :
  1. Time to first severe asthma exacerbation

Secondary Outcome Measures :
  1. Number of asthma exacerbations
  2. Mean use of as-needed medication
  3. Prescribed asthma medication
  4. Patient reported Outcomes
  5. Health care resource use
  6. Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events
  7. Induced sputum will be sampled from a subset of patients
  8. All variables assessed over the 6 months treatment period


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

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


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

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