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CompletedNCT01114906Updated Sep 19, 2011

Estimating the Use of Resources and the Costs of Treating Patients With Asthma in the Autonomous Community of Valencia

An observational study in Asthma and Valencia Autonomous Region, sponsored by AstraZeneca. Completed at 4 sites in Spain. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2011-09-19.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
292
Ages
15 Years and older
Sex
All
01

Study summary

This study has been conceived in the context of Health Outcomes Research where the outcomes of health interventions in routine clinical practice constitute the main objective of the research process. In the case of asthma in Spain, the investigators do not clearly know the use of resources generated by the patient with asthma, its impact on the effectiveness of the current approach of asthmatic patients and the overall efficiency of health interventions on asthmatic patients. This observational, retrospective and multicenter study aims to estimate the use of health care resources in managing patients with asthma and to determine the management of the disease in the usual clinical practice in Valencia Autonomous Region. The data will be obtained at primary care level from the Electronic Health Record SIA+GAIA data base and at hospital level from allergologists and pneumologists clinical records. The investigators plan to introduce 289 ambulatory patients followed-up in Primary or Specialized Care Services, older than 15 years of age, diagnosed of asthma at least one year before the beginning of the study. The inclusion period will be of 3 months and the retrospective data of 12 previous months of follow-up will be collected.

The direct and indirect use of resources will be collected in order to estimate the management and use of health care resources in managing patients with asthma in the Autonomous region of Valencia as primary endpoint and also to estimate the mean cost of asthmatic patient healthcare; to determine the global effectiveness and the efficiency of the actual asthmatic patient healthcare and to model the health budget according to different objectives of effectiveness for the next five years.

02

Conditions studied

  • Asthma
  • Valencia Autonomous Region

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Keywords

  • Asthma
  • Resource use
03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 292 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Ambulatory patients followed-up in Primary or Specialized Care Services (hospital)

Inclusion criteria

  • Ambulatory patients (Primary and Specialized Care)
  • Patients with a diagnose of asthma in the Outpatients' Electronic Health Record [Historia Clínica Ambulatoria electrónica (SIA + GAIA) database

Exclusion criteria

Exclusion Criteria:

  • Patients who have participated in a clinical trial in the last 12 months.
05

Study design

Time perspective
Retrospective
Enrollment
292 participants (actual)
06

What researchers measure

Primary outcomes

  1. Direct and indirect Resource Use of Asthma patients in 12 months

    Time frame: Once the patient has been included data refered to the previous 12 month following-up period will be recorded. Thus, all data will be recorded at that time-period. Only one data recording will be done.

07

Study locations

4 sites
  • Research Site
    Alcoy, Alicante, Spain
  • Research Site
    Vila-real, Castellón, Spain
  • Research Site
    Xativa, Valencia, Spain
  • Research Site
    Valencia, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01114906
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 3, 2010
Start date
Sep 2010
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Sep 19, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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