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

NCT01141465 COMPLETED

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.

Details

Lead sponsor	Research in Real-Life Ltd
Status	COMPLETED
Enrolment	815377
Start date	2001-01
Completion	2010-02

Conditions

• Asthma

Interventions

• Fluticasone / formoterol metered dose inhaler
• Fluticasone / salmeterol dry powder inhaler
• Budesonide / formoterol dry powder inhaler
• Fluticasone / salmeterol dry powder inhaler
• Fluticasone / salmeterol metred dose inhaler
• BUD/FOR dry powder inhaler

Primary outcomes

• Composite proxy for asthma control — One-year outcome period
  * No recorded hospital attendance for asthma, including admission, Accident \& Emergency (A\&E) attendance, out-of-hours attendance, or Out-Patient Department (OPD) attendance, AND * No prescriptions for oral steroids, AND * No GP consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
• Exacerbations (total and rate ratio) — One-year outcome period
  * Unscheduled hospital admissions / A\&E attendance for asthma, AND/OR * Use of oral steroids.
• GOAL Total Control (proxy measure to replicate total control as measured in the GOAL RCT in a real world patient population — 6 months (sensitivity analysis at 8 weeks)
  * No day-time symptoms; * No night-time symptoms; * No exacerbations; * No treatment-related adverse events * PEF ≥80% predicted = "normal" * No SABA use
• GOAL exacerbations — One year
  Absence of: * Documented episodes of hospitalisations AND/OR * Exacerbation treatment - oral steroids or antibiotics for asthma over one year

Countries

United Kingdom