Clinical trial NCT00884689: A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Symbicort SMART
Free Combination GCS/LABA treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: ClinResearch, GmbH
First posted: 2009-04-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthma treatment will not be assigned randomly, but will be administered at the discretion of the physicians according to standard medical practice. Each site should enrol 5 patients using the Symbicort® SMART® principle and 5 patients being prescribed a free combination GCS / LABA treatment.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Use of rescue medication
timeFrame: daily during 6 month
Secondary outcomes:
measure: Quality of life
timeFrame: 3 times during study
measure: Efficacy variables
timeFrame: during 6 month
measure: Safety variables
timeFrame: during 6 month
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Research Site
city: Bad Lippspringe
country: Germany
facility: Research Site
city: Bad Sassendorf
country: Germany
facility: Research Site
city: Bergkamen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Braunschweig
country: Germany
facility: Research Site
city: Buchholz
country: Germany
facility: Research Site
city: Chemnitz
country: Germany
facility: Research Site
city: Coswig
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Furth
country: Germany
facility: Research Site
city: Gelsenkirchen
country: Germany
facility: Research Site
city: Gutersloh
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Ketzin
country: Germany
facility: Research Site
city: Kothen
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Lohne
country: Germany
facility: Research Site
city: Lubeck
country: Germany
facility: Research Site
city: Ludenscheid
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Marl
country: Germany
facility: Research Site
city: Mittelbach
country: Germany
facility: Research Site
city: Muhlhausen
country: Germany
facility: Research Site
city: Mulheim
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Oschersleben
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Remscheid
country: Germany
facility: Research Site
city: Saarlouis
country: Germany
facility: Research Site
city: Schwetzingen
country: Germany
facility: Research Site
city: Steinhagen
country: Germany
facility: Research Site
city: Stockach
country: Germany
facility: Research Site
city: Wedel
country: Germany
facility: Research Site
city: Wesseling
country: Germany
facility: Research Site
city: Weyhe
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Kai Richter, MD
role: STUDY_DIRECTOR
References: