AsthmaEU-COASTNCT01376219
European Cost of Asthma Treatment
An observational study of Asthma, run by GlaxoSmithKline at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 2,752 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients diagnosed with asthma for at least 12 months and at least one antiasthmatic treatment during the last 12 months
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EU-COAST STUDY: European Cost of Asthma Treatment Economic Impact of Asthma Control
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.
Read more
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.
Read the detailed 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.
- Conditions
- Asthma
- Being tested
- asthma control test
- Keywords
- GINA, direct / indirect costs, exacerbations, European, asthma control, Asthma Control Test (TM - QualityMetric Incorporated)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthma control testOther
results of asthma control testing collected
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients entered in the study Receives: Other: asthma control test |
What is being measured
The primary outcome is the main question the study is designed to answer.
health care costs related to asthma according to the patients' asthma control level
Measured: 1 year
Secondary outcomes (3)
Direct costs and indirect costs of consumed resources
Measured: 1 year
Costs directly associated with asthma care and costs associated with asthma complications (exacerbations);
Measured: 1 year
Healthcare costs related to asthma (by control) and concomitant diseases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,752 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376219
- Sponsor's protocol ID
- 113553
- Acronym
- EU-COAST
- Status last verified
- Aug 2014
- First submitted
- 16 Jun 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EU-COAST STUDY: European Cost of Asthma Treatment Economic Impact of Asthma Control
- ClinicalTrials.gov ID
- NCT01376219
- Acronym / sponsor ID
- EU-COAST / 113553
- Conditions
- Asthma
- Keywords
- GINA, direct / indirect costs, exacerbations, European, asthma control, Asthma Control Test (TM - QualityMetric Incorporated)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,752 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: asthma control testAll patients entered in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with asthma for at least 12 months and at least one antiasthmatic treatment during the last 12 months
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| asthma control testresults of asthma control testing collected | Other | All patients |
Primary outcome
health care costs related to asthma according to the patients' asthma control level
Time frame: 1 year
3 secondary outcomes
Direct costs and indirect costs of consumed resources
Time frame: 1 year
Costs directly associated with asthma care and costs associated with asthma complications (exacerbations);
Time frame: 1 year
Healthcare costs related to asthma (by control) and concomitant diseases
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
health care costs related to asthma according to the patients' asthma control level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2014.