Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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
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.
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.
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Observational Model: Cohort, Time Perspective: Retrospective
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