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

NCT01141452 | Completed DMC

• 1 other identifier: BA5
• Study Type: observational
• Target: 815,377
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

chronic obstructive pulmonary disease; inhaled corticosteroid; increase; initiate; exacerbations; treatment success

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (10)

• COPD treatment success factoring in change in therapy

  Two-year outcome period

• COPD treatment success factoring in change in therapy unrelated to cost savings

  Two-year outcome period

• Change in ICS dosing

  Two-year outcome period

• Rate of hospitalisations

  Two-year outcomes

• SABA usage

  Two-year outcome

Study Arms (6)

IPDA FP MDI

Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as fluticasone via metered dose inhaler

Drug: Fluticasone propionate metred dose inhaler

IPDA HFA-BDP MDI

Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as extra-fine hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

Drug: Extra-fine hydrofluoroalkane beclomethasone MDI

IPDA CFC-BDP MDI

Patients who were on inhaled corticosteroid therapy as part of their baseline therapy (any ICS therapy) who, at an index prescription date, stepped-up ICS dose as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler

Drug: Chlorofluorocarbon beclomethasone metered dose inhaler

IPDI CFC-BDP MDI

Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as chlorofluorocarbon beclomethasone dipropionate via metered dose inhaler

Drug: Chlorofluorocarbon beclomethasone dipropionate

IPDI HFA-BDP MDI

Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

Drug: Hydrofluoroalkane beclomethasone metred dose inhaler

IPDI FP MDI

Patients who were not receiving inhaled corticosteroid therapy as part of their baseline therapy but who, at an index prescription date, initiated ICS as fluticasone propionate via metered dose inhaler

Drug: Fluticasone propionate metred dose inhaler

Interventions

Extra-fine hydrofluoroalkane beclomethasone MDI DRUG

Step-up in baseline BDP-equivalent ICS dose

Also known as: Qvar®

IPDA HFA-BDP MDI

Chlorofluorocarbon beclomethasone metered dose inhaler DRUG

Step-up in baseline BDP-equivalent ICS dose

IPDA CFC-BDP MDI

Fluticasone propionate metred dose inhaler DRUG

Step-up in baseline BDP-equivalent ICS dose

IPDA FP MDI

Hydrofluoroalkane beclomethasone metred dose inhaler DRUG

Initiation of ICS therapy

Also known as: Qvar®

IPDI HFA-BDP MDI

Chlorofluorocarbon beclomethasone dipropionate DRUG

Initiation of ICS therapy

IPDI CFC-BDP MDI

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

General Practice Research Database

London, London, SW8 5NQ, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 15672843 BACKGROUND

• 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.

  PMID: 17113277 BACKGROUND

• 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.

  PMID: 16275363 BACKGROUND

• 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.

  PMID: 9877489 BACKGROUND

• 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.

  PMID: 9794854 BACKGROUND

Related Links

• Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• David Price, Prof. MD

  Company Director

  PRINCIPAL INVESTIGATOR

• Alison Chisholm, MSc

  Research Project Director

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: January 1, 2001
• Primary Completion: June 1, 2007
• Study Completion: July 1, 2007
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

GB (1)