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Local Phase 4 Pan-European SMART Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00463866
Recruitment Status : Completed
First Posted : April 20, 2007
Results First Posted : March 22, 2010
Last Update Posted : March 22, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/formoterol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Number of Severe Asthma Exacerbations Per Participant. [ Time Frame: 6 months ]
    Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.


Secondary Outcome Measures :
  1. Fraction of Participants With Severe Asthma Exacerbation [ Time Frame: 6 months. ]
    The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

  2. Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. [ Time Frame: 6 months. ]
    A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant

  3. Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation [ Time Frame: 6 months. ]
    Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

  4. Mean Daily Number of Inhalations of As-needed Medication. [ Time Frame: 4 weeks ]
    The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.

  5. Percent of Participants With a Well Controlled Asthma Week. [ Time Frame: 6 months. ]
    The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.

  6. Mean Overall Asthma Control Questionnaire (ACQ) Score [ Time Frame: 6 months. ]
    The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.

  7. The Mean Total Daily Dose of Steroids From Symbicort. [ Time Frame: 4 weeks ]
    The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.

  8. Mean Cost Per Participant Per Country [ Time Frame: 6 months ]
    Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at out-patient clinics
  • >18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Exclusion Criteria:

  • Asthma exacerbation within the last 14 days prior to study start
  • subject aged >40 years with a smoking history of >10pack-years
  • subjects with chronic obstructive lung disease or other significant respiratory disease
Contacts and Locations
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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): NCT00463866


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Michel Aubier, Prof FRANCE
Study Chair: Juliette Ostinelli, MD AstraZeneca, MC France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00463866    
Other Study ID Numbers: D5890L00022
EUROSMART
EudraCTNo. 2006-006512-30
First Posted: April 20, 2007    Key Record Dates
Results First Posted: March 22, 2010
Last Update Posted: March 22, 2010
Last Verified: March 2010
Keywords provided by AstraZeneca:
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action