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Completed

NCT Number: NCT00884689

A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®

The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.

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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

Observational

Primary location

Research Site, Aschaffenburg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1.
  • Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
  • A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit 1.
  • A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:
  • Oral/systemic GCS treatment due to asthma for at least 3 days
  • Unscheduled health-care visit due to asthmaHospitalization or emergency room visit because of asthma requiring treatment with oral/systemic GCS

Exclusion criteria

  • Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
  • Use of ß-blocking agents
  • Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.

Treatment and study plan

Primary outcomes

  1. Use of rescue medication

    Time frame: daily during 6 month

Secondary outcomes

  1. Quality of life

    Time frame: 3 times during study

  2. Efficacy variables

    Time frame: during 6 month

  3. Safety variables

    Time frame: during 6 month

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • ClinResearch, GmbH

Registry information

Official study title

A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART® 1-2 Inhalations b.i.d. as Maintenance Therapy Plus Additional Inhalations As-needed, Compared to Patients Treated With a Free Combination of an Inhaled Glucocorticosteroid and an Inhaled Long Acting ß2-agonist Plus as Needed Inhalations of a Short Acting ß2 Agonist.

Important dates

Study start
2009
Study completion
2010
First posted
Apr 21, 2009
Registry last updated
Mar 31, 2011

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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