NCT01141452

Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD

Retrospective, Real-life Evaluation of the Effectiveness, Cost-effectiveness and Direct Healthcare Costs of Qvar Pressurised Metered-dose Inhaler (pMDI) Compared With Beclometasone Dipropionate pMDI and Fluticasone pMDI in the Management of Chronic Obstructive Pulmonary Disease (COPD) in a Representative UK Primary Care Patient Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 815,377 (actual)
• Sponsor: Research in Real-Life Ltd · Network
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing chronic obstructive pulmonary disease (COPD) in primary care patients with evidence of COPD who either initiate inhaled corticosteroid (ICS) therapy, or have an increase in their ICS dose, as hydrofluoroalkane (HFA) beclometasone dipropionate (BDP) (hereafter Qvar®), CFC-BDP (hereafter BDP) and fluticasone propionate (FP) via pressurised metered-dose inhalers.

Detailed description

Current asthma guidelines in the UK are underpinned by evidence derived from randomised controlled trials (RCTs). Although RCT data are considered the gold standard, patients recruited to asthma RCTs are estimated to represent less than 10% of the UK's asthma population. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is, therefore, a need for more representative RCTs and real-life observational studies to inform existing guidelines and help optimise asthma outcomes. Short randomised trials have shown that Qvar is at least as effective as FP pMDI and as BDP pMDI at half the prescribed dose in patients with asthma. There is also evidence to suggest that, in adults, HFA formulation as used by Qvar (featuring BDP in solution rather than suspension) may achieve 10-fold higher deposition compared with CFC-BDP.4 Furthermore, deposition in the peripheral regions is higher compared with CFC-BDP and the fine-particle formulation also offers greater tolerance of poor co-ordination of breathing and inhaler actuation, resulting in lower oro-pharyngeal deposition compared with CFC-BDP. Evidence of the efficacy of ICS monotherapy in COPD remains mixed at this time. While Qvar and ICS monotherapy use in the treatment of COPD is currently off-label, it occurs in clinical practice in two common scenarios: 1. before a diagnosis of COPD is made 2. unlicensed use as monotherapy, or in combination with long-acting bronchodilators The study hypothesis, therefore, is that Qvar treatment in COPD may be associated with improved disease management and control (as assessed by effectiveness, cost-effectiveness and direct healthcare costs of managing COPD) compared with other commonly used ICS therapies, namely BPD and FP, by virtue of its improved deposition throughout the lungs and the small airways.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Extra-fine hydrofluoroalkane beclomethasone MDI	Step-up in baseline BDP-equivalent ICS dose
DRUG	Chlorofluorocarbon beclomethasone metered dose inhaler	Step-up in baseline BDP-equivalent ICS dose
DRUG	Fluticasone propionate metred dose inhaler	Step-up in baseline BDP-equivalent ICS dose
DRUG	Fluticasone propionate metred dose inhaler	Initiation of ICS therapy
DRUG	Hydrofluoroalkane beclomethasone metred dose inhaler	Initiation of ICS therapy
DRUG	Chlorofluorocarbon beclomethasone dipropionate	Initiation of ICS therapy

Timeline

• Start date: 2001-01-01
• Primary completion: 2007-06-01
• Completion: 2007-07-01
• First posted: 2010-06-10
• Last updated: 2011-03-08

Locations

1 site across 1 country: United Kingdom