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

Asthma Clinical Trial

— REALL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00628563
• Other study ID #: GP501RGD0685
• Status: Completed
• Phase: N/A
• First received: January 31, 2008
• Last updated: February 26, 2016
• Start date: September 2007
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50000
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	Medical Practices	UK

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No