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

NCT ID: NCT00628563

Last Updated: 2016-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Asthma patients

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Price

Role: PRINCIPAL_INVESTIGATOR

University of Aberdeen

Locations

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Medical Practices

UK, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GP501RGD0685

Identifier Type: -

Identifier Source: org_study_id

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