NIS-observe Treatment Efficacy in Maintaining Symptoms Control in Moderate/Severe Asthma With Symbicort SMART

The primary objective of this non-interventional study is to evaluate efficacy of Symbicort® SMART treatment in adult patients with moderate to severe asthma using ACQ scores during 6 months period

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Key information

Conditions

Moderate/Severe Asthma Asthma Bronchial Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Diseases, Obstructive Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alba Iulia, Romania

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients eligible for entry into study are the patients diagnosed with moderate to severe asthma, that the doctors have already decided to treat with Symbicort SMART within the last month, before inclusion in this program
All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.

Exclusion criteria

All the patients who have a known hypersensitivity to Symbicort or any of its excipients will not be included in this study.
As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.

Treatment and study plan

Primary outcomes

Asthma Control Questionnaire ACQ

Time frame: 5 visits (V1-week 0, V2-week 4, V3-week 8, V4-week 16, V5-week 24)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

SMART Way of Treating Asthma. Non-interventional Study to Evaluate Clinical Efficacy of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Patients With Moderate and Severe Asthma

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 5, 2008
Registry last updated: Dec 2, 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.

Published trials that share one or more normalized conditions with this study.

Completed