REALL: A Retrospective Observational Study to Compare the Effectiveness and Cost-Effectiveness Between Different Step-3 Asthma Treatment Strategies

REALL STUDY: A Retrospective Observational Study to Compare the Effectiveness and Cost-effectiveness Between Different Step-3 Asthma Treatment Strategies in Real Life Patients in Primary Care

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00628563

Acronym

REALL

Enrollment

50000

Registered

2008-03-05

Start date

2007-09-30

Completion date

2015-12-31

Last updated

2016-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

This is a retrospective observational study utilising anonymised individual patient clinical and prescribing information routinely collected by UK General Practitioners (GPs). This information will be observed for two years, one year pre and one year post- Index Prescription Date (IPD). The IPD is the date when a patient was first switched to any option of the step-3 asthma treatment regimen. The one year before the IPD is the baseline period and will be reviewed for risk factors and confounding factors. The one year after the IPD is the outcome period and will be observed to see the outcomes of the new treatment.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

1. Patients with a physician diagnosis of asthma who have stepped-up to any option of step-3 asthma treatment (trial therapy), and; 2. Patients with the trial therapy who have data in their records for at least one year for the baseline period and at least one year for the outcome period.

Exclusion criteria

1. Patients who were not prescribed with any option of step-3 treatment (the trial therapy) during the study period. 2. Patients treated with the trial therapy, but do not have data in their records for at least one year for the baseline period and at least one year for the outcome period. 3. Patients treated with long-acting anticholinergic drugs, either alone or in combination with other therapy. 4. Patients with a physician diagnosis of COPD with or without asthma. 5. Patients who have resolved from asthma; i.e. patients who were previously diagnosed as having asthma, have now been undiagnosed.

Design outcomes

Primary

Measure	Time frame
The achievement of asthma control. This will be assessed by evaluating the patient data for one year in the outcome period. On this basis patients will be divided into two groups	1 year

Secondary

Measure	Time frame
The asthma control will be monitored, directly from patients' point of view, by Royal College of Physician (RCP) 3 questions at least after 6 months of IPD (British Thoracic Society (BTS) July, 2007).	1 year

Countries

United Kingdom

Outcome results