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

Sponsored by:	University of Aberdeen
Information provided by:	University of Aberdeen
ClinicalTrials.gov Identifier:	NCT00628563

Purpose

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.

Condition
Asthma

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Observational
Study Design:	Retrospective
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

Further study details as provided by University of Aberdeen:

Primary Outcome Measures:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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). [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	50000
Study Start Date:	September 2007
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Asthma patients

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Patients with a physician diagnosis of asthma who have stepped-up to any option of step-3 asthma treatment (trial therapy), and;
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.

Criteria

Inclusion Criteria:

Patients with a physician diagnosis of asthma who have stepped-up to any option of step-3 asthma treatment (trial therapy), and;
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:

Patients who were not prescribed with any option of step-3 treatment (the trial therapy) during the study period.
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.
Patients treated with long-acting anticholinergic drugs, either alone or in combination with other therapy.
Patients with a physician diagnosis of COPD with or without asthma.
Patients who have resolved from asthma; i.e. patients who were previously diagnosed as having asthma, have now been undiagnosed.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628563

Contacts

Contact: Sharmina Begum

01224 550921

s.w.begum@abdn.ac.uk

Locations

United Kingdom
Medical Practices	Recruiting
UK, United Kingdom
Sub-Investigator: Sharmina Begum

Sponsors and Collaborators

University of Aberdeen

Investigators

Principal Investigator:

David Price

University of Aberdeen

More Information

Responsible Party:	University of Aberdeen ( David Price )
Study ID Numbers:	GP501RGD0685
Study First Received:	January 31, 2008
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00628563
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009