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CompletedNCT00628563REALLUpdated Feb 29, 2016

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

An observational study in Asthma, sponsored by University of Aberdeen. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2016-02-29.

Sponsored by University of Aberdeen · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
50,000
Sex
All
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Study summary

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.

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Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 50,000 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

University of Aberdeen is the lead sponsor of 170 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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.

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

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.
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Study design

Time perspective
Retrospective
Enrollment
50,000 participants (actual)

Groups and cohorts

  • 1

    Asthma patients

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

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Study locations

1 site
  • Medical Practices
    UK, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00628563
Lead sponsor
University of Aberdeen
Responsible party
Sponsor
First posted
Mar 5, 2008
Start date
Sep 2007
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 29, 2016

Study contacts

David Price
principal investigator · University of Aberdeen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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