European Cost of Asthma Treatment

Asthma Clinical Trial

— EU-COAST  

Official title:

EU-COAST STUDY: European Cost of Asthma Treatment Economic Impact of Asthma Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376219
• Other study ID #: 113553
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: August 11, 2014
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: August 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Espanola de Medicamentos y Productos SanitariosFrance: GSK observational study
• Study type: Observational

Clinical Trial 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.

Description:

A European observational retrospective bottom-up cost of illness study will be designed based upon a sample of patients with asthma. Investigators will be general practitioners.

They will have to enrol a sample of patients with asthma.

The level of asthma control will be evaluated with 2 methods:

• Firstly by using the auto-test Asthma Control Test (TM - QualityMetric Incorporated) which allows to assess the level of control on a 4-week period by distinguishing controlled and uncontrolled patients ;

• Secondly by using the GINA's asthma control criteria to measure the level of control in the last 3 months. The GINA classification will allow ranging patients in 3 groups (controlled, partly controlled and uncontrolled patients) and comprises a measure of lung function using a peak expiratory flow measurement (PEF) or a spirometric examination.

The study design will necessitate only one visit per patient with a retrospective data collection over a three-month period. This period is the maximum possible retrospective duration to avoid memory biases.

A questionnaire will be filled-up by the general practitioner. Data collected during the visit will be demographic data, medical history of patients, physician and paramedic's visits, treatment, diagnosis and lab tests, hospitalizations, rehabilitation, and absence from work during the last three months. A PEF or a spirometric result will be also requested. Patients will have to complete the Asthma Control test (TM - QualityMetric Incorporated) questionnaire. To assess the quality of life, patients will also have to complete the EQ-5D questionnaire.

As the time horizon of the asthma control concept is one month or shorter, the cost analysis will be first done taking into account this duration (the cost will be compared with the Asthma Control Test (TM - QualityMetric Incorporated) score), and secondly, on the three months period (the cost will be compared to the GINA's criteria).

To take into account seasonality, the overall population of patients will be enrolled in four quarterly waves. The data collection will therefore require one full year.

All the data collected will be centralized, captured and analyzed. Costing will be done using both societal and payer perspectives without any discounting. Results will be provided by period and by asthma control level and according to the patient profile (age, sex, etc.).

The number of patients needed to be enrolled was calculated taking into account the precision of the average cost estimate in the lower size group (i.e patients with optimal control) for each period in each country. In each country, at least 380 patients will be enrolled per wave to obtain a total population of 152 patients with optimal control. Overall, 3,040 will be enrolled all over the study year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2752
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• asthma control test
results of asthma control testing collected

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health care costs related to asthma according to the patients' asthma control level		1 year	No
Secondary	Direct costs and indirect costs of consumed resources		1 year	No
Secondary	Costs directly associated with asthma care and costs associated with asthma complications (exacerbations);		1 year	No
Secondary	Healthcare costs related to asthma (by control) and concomitant diseases		1 year	No