CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 815,377 enrolled
Drug / intervention
Fluticasone / formoterol metered dose inhaler +5 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/NCT01141465
NCT01141465N/ACompleted

A Retrospective Evaluation of the Effectiveness of Fixed-dose Combination Inhaled Corticosteroid /. Long-acting Beta Agonist (ICS/LABA) Therapy in the Management of Asthma in a Representative UK Primary Care Population

Research in Real-Life Ltd·observational·Posted Jun 10, 2010·Updated Jun 10, 2010

In Brief

An observational study evaluating Fluticasone / formoterol metered dose inhaler, Fluticasone / salmeterol dry powder inhaler, and 3 other interventions for Asthma. Completed, enrolled 815,377 participants across 1 site.

Detailed Summary

This study will evaluate and compare the effectiveness of asthma management in patients with evidence of persistent asthma following a switch in asthma therapy to combination inhaled glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either: fixed-combination fluticasone propionate / salmeterol (FP/SAL; Seretide®) via pressurised metered-dose inhaler (pMDI) or dry-powder inhaler (DPI) plus as-needed (prn) reliever therapy (salbutamol as DPI, BAI or pMDI), or fixed-combination budesonide / formoterol (BUD/FOR; Symbicort®) via DPI plus prn reliever therapy (salbutamol as DPI, BAI or pMDI or bricanyl as DPI). The final analysis plan will define exact comparators and age groups to be studied after reviewing baseline data.

Study Details

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

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 10, 2010
Enrollment StartJan 1, 2001
Primary CompletionJun 1, 2007
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 16.1 years ago

Interventions

Fluticasone / formoterol metered dose inhalerdrug

Prescribed at the same BDP-equivalent dose as baseline ICS

Fluticasone / salmeterol dry powder inhalerdrug

Prescribed at the same BDP-equivalent dose as baseline ICS

Budesonide / formoterol dry powder inhalerdrug

Prescribed at the same BDP-equivalent dose as baseline ICS

Fluticasone / salmeterol dry powder inhalerdrug

Prescribed at ≥twice BDP-equivalent dose as baseline ICS

Fluticasone / salmeterol metred dose inhalerdrug

Prescribed at ≥twice BDP-equivalent dose as baseline ICS

BUD/FOR dry powder inhalerdrug

Prescribed at ≥twice BDP-equivalent dose as baseline ICS