CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 815,377 enrolled
Drug / intervention
Extra-fine hydrofluoroalkane-beclometasone dipropionate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01697722
NCT01697722N/ACompleted

A Retrospective Evaluation of Effectiveness and Cost-effectiveness of Extrafine HFA-BDP Compared With Combination ICS/LABA Therapy in the Management of Asthma in a Representative Population of UK Primary Care Patients

Research in Real-Life Ltd·observational·Posted Oct 2, 2012·Updated Oct 4, 2012

In Brief

An observational study evaluating Extra-fine hydrofluoroalkane-beclometasone dipropionate and ICS / LABA via separate pMDI and / or BAI inhalers for Asthma. Completed, enrolled 815,377 participants across 1 site.

Detailed Summary

This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of asthma management in patients with evidence of persistent asthma following an increase in asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS) using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone propionate / salmeterol \[FP/SAL\] or budesonide / formoterol \[BUD/FOR\]) or separate pMDIs and BAIs.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2, 2012
Enrollment StartJan 1, 1991
Primary CompletionJun 1, 2007
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 16.4 yearsPosted 13.8 years ago

Interventions

Extra-fine hydrofluoroalkane-beclometasone dipropionatedrug

Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI

ICS / LABA via separate pMDI and / or BAI inhalersdrug

A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose