Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

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.
    

Intervention name(s): Extra-fine hydrofluoroalkane beclomethasone MDI; Chlorofluorocarbon beclomethasone metered dose inhaler; Fluticasone propionate metred dose inhaler; Fluticasone propionate metred dose inhaler; Hydrofluoroalkane beclomethasone metred dose inhaler; Chlorofluorocarbon beclomethasone dipropionate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Step-up in baseline BDP-equivalent ICS dose; Step-up in baseline BDP-equivalent ICS dose; Step-up in baseline BDP-equivalent ICS dose; Initiation of ICS therapy; Initiation of ICS therapy; Initiation of ICS therapy
Other intervention name(s): Qvar®; Qvar®
Intervention MeSH terms: Fluticasone; Xhance; Beclomethasone
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care COPD patients who at an index prescription date either initiated ICS therapy
        as extrafine HFA-BDP, CFC-BDP or FP via MDI or had an increase in baseline BDP-equivalent
        ICS dose the index data as extrafine HFA-BDP, CFC-BDP or FP via MDI
      
Keywords: chronic obstructive pulmonary disease; inhaled corticosteroid; increase; initiate; exacerbations; treatment success