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Completed

NCT Number: NCT00463866

Local Phase 4 Pan-European SMART Study

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

budesonide/formoterol

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2007
Study completion
2008
First posted
Apr 20, 2007
Registry last updated
Mar 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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