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

January 31, 2008
February 26, 2008
September 2007
May 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00628563 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
REALL: A Retrospective Observational Study to Compare the Effectiveness and Cost-Effectiveness Between Different Step-3 Asthma Treatment Strategies
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.

Not Provided
Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample
  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.
Asthma
Not Provided
1
Asthma patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50000
July 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact: Sharmina Begum 01224 550921 s.w.begum@abdn.ac.uk
United Kingdom
 
NCT00628563
GP501RGD0685
Yes
David Price, University of Aberdeen
University of Aberdeen
Not Provided
Principal Investigator: David Price University of Aberdeen
University of Aberdeen
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP