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

Chronic Obstructive Pulmonary Disease Clinical Trial

— QvarCOPD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141452
• Other study ID #: BA5
• Status: Completed
• Phase: N/A
• First received: June 9, 2010
• Last updated: March 7, 2011
• Start date: January 2001
• Est. completion date: July 2007

Study information

• Verified date: March 2011
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815377
• Est. completion date: July 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Extra-fine hydrofluoroalkane beclomethasone MDI
Step-up in baseline BDP-equivalent ICS dose
• Chlorofluorocarbon beclomethasone metered dose inhaler
Step-up in baseline BDP-equivalent ICS dose
• Fluticasone propionate metred dose inhaler
Step-up in baseline BDP-equivalent ICS dose
• Fluticasone propionate metred dose inhaler
Initiation of ICS therapy
• Hydrofluoroalkane beclomethasone metred dose inhaler
Initiation of ICS therapy
• Chlorofluorocarbon beclomethasone dipropionate
Initiation of ICS therapy

Locations

Country	Name	City	State
United Kingdom	General Practice Research Database	London

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Teva Pharmaceutical Industries

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. Review. — View Citation

Herland K, Akselsen JP, Skjønsberg 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. — View 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. — View 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. Epub 2006 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of exacerbations; exacerbation rate ratio; time to first after IPD	Where exacerbations are defined as: Unscheduled hospital admissions / A&E attendances:*; For COPD (definite code) and; Lower respiratory tract infections (LRTI) treated with antibiotics; Acute use of oral steroids; Antibiotics use with a lower respiratory read code within a ±5-day window	Two-year outcome period	No
Primary	COPD treatment success	No recorded hospital attendance for COPD or respiratory related events (i.e. with a lower respiratory read code), including: Admission; A&E attendance; Out of hours attendance; No exacerbations of COPD ("definite" plus "possible" prescriptions as defined above); No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.	Two-year outcome period	No
Secondary	COPD treatment success factoring in change in therapy	Defined as absence of: Exacerbations; and/or; Increase in dose of inhaled steroid; and/or; Change in delivery device, and/or; Change in ICS; Use of additional therapy not received in baseline year, split by: LABA; Theophylline; LTRAs.	Two-year outcome period	No
Secondary	COPD treatment success factoring in change in therapy unrelated to cost savings	Defined as absence of: Exacerbations; and/or; Increase in dose of inhaled steroid; and/or; Use of additional therapy not received in baseline year, split by: LABA; Theophylline; LTRAs.	Two-year outcome period	No
Secondary	Change in ICS dosing	Proportion of patients who: Remained on the same ICS (and/or combination therapy) throughout the outcome period; Remained on the same ICS dose throughout the outcome period, but had another therapy added; Received an ICS dose increase and / or therapy added to their ICS during the outcome period.	Two-year outcome period	No
Secondary	Rate of hospitalisations	Where hospitalisations are defined as; Admissions and A&E coded as: lower respiratory-related, or; for COPD; Admissions and A&E coded as: lower respiratory-related, or; for COPD; admission attendance occurring within a ±7 day window of an LRTI treated with antibiotics.	Two-year outcomes	Yes
Secondary	SABA usage	Average SABA daily dose, categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg.	Two-year outcome	No
Secondary	Mortality	Respiratory mortality; All-cause mortality	Two-years	Yes
Secondary	Incidence of pneumonia	Unconfirmed (i.e. all unique patients with codes for pneumonia) AND; Confirmed: chest X-ray within a month of a pneumonia diagnosis, or; hospitalisation within a month of a pneumonia diagnosis	Two-year outcome	Yes
Secondary	Incremental cost effectiveness ratio	Difference in costs (HFA-BDP the comparator) over difference in effectiveness (using primary outcome of exacerbations)	Two-year outcome	No
Secondary	Cost of total healthcare treatment	Costs for each intervention: including ICS costs; excluding ICS costs	Two-year outcome	No
Secondary	Costs for COPD treatment	Costs of COPD treatment: including ICS costs; excluding ICS costs	Two-year outcome	No

External Links

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