Clinical trial NCT01141452: Real-life Effectiveness and Cost-effectiveness of Qvar Versus FP and BDP in the Management of COPD
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: chronic obstructive pulmonary disease
inhaled corticosteroid
increase
initiate
exacerbations
treatment success
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2010-06-10
Enrollment: 815377
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged ≥40 years at index prescription date
* COPD diagnosis:

  * diagnostic code, and
  * ≥2 prescriptions for COPD therapy in baseline year (at different points in time)

    * For the ICS increase cohort (i.e. IPDA) ≥1 of these prescriptions must be for ICS therapy.
    * Commence ICS therapy at any time (even if before COPD diagnosis is made)

Exclusion Criteria:

- A diagnostic read code for any other chronic respiratory disease (except asthma)

Primary outcomes:
measure: Total number of exacerbations; exacerbation rate ratio; time to first after IPD
timeFrame: Two-year outcome period
measure: COPD treatment success
timeFrame: Two-year outcome period
Secondary outcomes:
measure: COPD treatment success factoring in change in therapy
timeFrame: Two-year outcome period
measure: COPD treatment success factoring in change in therapy unrelated to cost savings
timeFrame: Two-year outcome period
measure: Change in ICS dosing
timeFrame: Two-year outcome period
measure: Rate of hospitalisations
timeFrame: Two-year outcomes
measure: SABA usage
timeFrame: Two-year outcome
measure: Mortality
timeFrame: Two-years
measure: Incidence of pneumonia
timeFrame: Two-year outcome
measure: Incremental cost effectiveness ratio
timeFrame: Two-year outcome
measure: Cost of total healthcare treatment
timeFrame: Two-year outcome
measure: Costs for COPD treatment
timeFrame: Two-year outcome
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: General Practice Research Database
Study officials:
affiliation: Company Director
name: David Price, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Project Director
name: Alison Chisholm, MSc
role: STUDY_DIRECTOR
References:
citation: Herland K, Akselsen JP, Skjonsberg OH, Bjermer L. How representative are clinical study patients with asthma or COPD for a larger "real life" population of patients with obstructive lung disease? Respir Med. 2005 Jan;99(1):11-9. doi: 10.1016/j.rmed.2004.03.026.
citation: Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. External validity of randomized controlled trials in COPD. Respir Med. 2007 Jun;101(6):1313-20. doi: 10.1016/j.rmed.2006.10.011. Epub 2006 Nov 17.
citation: Appleton SL, Adams RJ, Wilson DH, Taylor AW, Ruffin RE; North West Adelaide Cohort Health Study Team. Spirometric criteria for asthma: adding further evidence to the debate. J Allergy Clin Immunol. 2005 Nov;116(5):976-82. doi: 10.1016/j.jaci.2005.08.034.
citation: Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998 Dec;12(6):1346-53. doi: 10.1183/09031936.98.12061346.
citation: Barber JA, Thompson SG. Analysis and interpretation of cost data in randomised controlled trials: review of published studies. BMJ. 1998 Oct 31;317(7167):1195-200. doi: 10.1136/bmj.317.7167.1195.