- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00628563
REALL: A Retrospective Observational Study to Compare the Effectiveness and Cost-Effectiveness Between Different Step-3 Asthma Treatment Strategies (REALL)
February 26, 2016 updated by: University of Aberdeen
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
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
50000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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UK, United Kingdom
- Medical Practices
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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1
Asthma patients
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What is the study measuring?
Primary Outcome Measures
Outcome 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
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome 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).
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Price, University of Aberdeen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 31, 2008
First Submitted That Met QC Criteria
February 26, 2008
First Posted (Estimate)
March 5, 2008
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
February 26, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GP501RGD0685
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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