European Cost of Asthma Treatment

NCT01376219 | Completed

• 1 other identifier: 113553
• Study Type: observational
• Target: 2,752
• Locations: 1 country
• Sites: 1

Brief Summary

The economic cost of asthma is considerable both in terms of direct medical costs (such as the cost of pharmaceuticals and hospital admissions) and indirect medical costs (such as time lost from work and premature death). The costs of asthma depend on the severity of disease and the extent to which exacerbations are avoided. Moreover, poor control of asthma symptoms is a major issue that can result in adverse clinical and economic outcomes. According to GINA guidelines, the goal of asthma treatment is to achieve and maintain asthma control. Such an objective can be reached in a majority of patients with a pharmacologic intervention strategy developed in partnership between the patient/family and the doctor. Validated measures for assessing asthma control score goals as continuous variables and provide numerical values to distinguish different levels of control. Among them, the Asthma Control Test (TM - QualityMetric Incorporated) is widely recognized. Few data exist on the relationship between asthma control and health care consumption. Some models for predicting asthma costs have been proposed. However, these models only attempt to assess costs associated with medications and/or asthma exacerbations. Furthermore, in such studies, asthma control was not defined accordingly to current international criteria. Considering the increasing interest of health authorities in reducing asthma associated costs and improving quality of care, it appears necessary to study the relationship between the cost and the level of control.

Conditions

Asthma

Keywords

GINA; direct / indirect costs; exacerbations; European; asthma control; Asthma Control Test (TM - QualityMetric Incorporated)

Outcome Measures

Primary Outcomes (1)

• health care costs related to asthma according to the patients' asthma control level

  1 year

Secondary Outcomes (3)

• Direct costs and indirect costs of consumed resources

  1 year

• Costs directly associated with asthma care and costs associated with asthma complications (exacerbations);

  1 year

• Healthcare costs related to asthma (by control) and concomitant diseases

  1 year

Study Arms (1)

All patients

All patients entered in the study

Other: asthma control test

Interventions

asthma control test OTHER

results of asthma control testing collected

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients diagnosed with asthma for at least 12 months and at least one antiasthmatic treatment during the last 12 months

You may qualify if:

• Adult outpatients, male or female aged ≥ 18 ;
• Patient diagnosed with asthma for at least 12 months and at least one antiasthmatic treatment in the last 12 months;
• Patient has read the information letter and the informed consent (if applicable).

You may not qualify if:

• Patient already included in this study;
• Patient who participated into a clinical trial during the last 6 months;
• Patient aged \>=45 with an history of smoking of at least 20 packs-year;
• Patient with a chronic obstructive bronchopneumopathy
• Pregnant women.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 20, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

ES (1)