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MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00242411
First received: October 18, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes

October 18, 2005
January 21, 2011
September 2004
October 2006   (final data collection date for primary outcome measure)
Time to first severe asthma exacerbation
Same as current
Complete list of historical versions of study NCT00242411 on ClinicalTrials.gov Archive Site
  • Number of asthma exacerbations
  • Mean use of as-needed medication
  • Prescribed asthma medication
  • Asthma Control Questionnaire
  • Safety: serious adverse events and discontinuations due to adverse events
  • All variables assessed over the 6 month treatment period
  • Number of asthma exacerbations
  • Mean use of as-needed medication
  • Prescribed asthma medication
  • Asthma Control Questionnaire
  • Safety: Serious Adverse Events and discontinuations due to adverse events
  • All variables assessed over the 6 months treatment period
Not Provided
Not Provided
 
MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults
A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults. A Randomized, Open, Parallel-group, Multicentre 26-weeks Study

The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Budesonide/Formoterol Turbuhaler
  • Drug: Conventional Best Asthma Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1900
October 2006
October 2006   (final data collection date for primary outcome measure)

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 may jeopardize the safety of the patient.

Additional inclusion and exclusion criteria will be evaluated by the investigator.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Norway
 
NCT00242411
D5890L00008
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Symbicort Medical Science Director, MD AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP