Overview

Real-world Effectiveness of Combination Therapy in Asthma

Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Research in Real-Life Ltd
Collaborator:
Mundipharma Research Limited
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Fluticasone-Salmeterol Drug Combination
Formoterol Fumarate
Salmeterol Xinafoate
Xhance
Criteria
Inclusion Criteria:

- Aged: 4-80 years: Paediatric cohort (aged 4-11 years); Adult cohort (aged 12-69
years); Elderly cohort (aged 70-80 years.

- Evidence of asthma: i.e. a diagnostic code of asthma or ≥2 prescriptions for asthma at
different points in time during the prior year, including one ICS prescription.

- Be on current asthma therapy: i.e. ≥1 asthma prescriptions in the prior year, and at
least 1 other asthma prescription during the same period.

- Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at
least one year of UTS outcome data (following the IPD).

Exclusion Criteria:

- Diagnostic read code for chronic respiratory disease (including COPD) at any time

- On maintenance oral steroid therapy at baseline

- Any patients receiving a combination inhaler in addition to their separate ICS inhaler
in the baseline year.