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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00628563
First Posted: March 5, 2008
Last Update Posted: February 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aberdeen
  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

Study Type: Observational
Study Design: Time Perspective: 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 ]

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 ]

Enrollment: 50000
Study Start Date: September 2007
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Asthma patients

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  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.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00628563


Locations
United Kingdom
Medical Practices
UK, United Kingdom
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: David Price University of Aberdeen
  More Information

Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT00628563     History of Changes
Other Study ID Numbers: GP501RGD0685
First Submitted: January 31, 2008
First Posted: March 5, 2008
Last Update Posted: February 29, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases