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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Aberdeen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT00628563
First received: January 31, 2008
Last updated: February 26, 2008
Last verified: February 2008
  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

Resource links provided by NLM:


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 ]

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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

ClinicalTrials.gov processed this record on September 18, 2014