Clinical trial NCT01877954: Qvar vs FP in Pediatrics
Official title: Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: hydrofluoroalkane beclomethasone
fluticasone
paediatrics
real-life
observational
primary care
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2013-06-14
Enrollment: 2654
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthma patients who initiate ICS therapy as one of:

HFA-BDP pMDI FP pMDI

Brief summary: The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.

Detailed description: Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:

1. Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
2. Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.

Eligibility criteria: Inclusion Criteria:

1. Aged: 5-11 years
2. Evidence of asthma (diagnostic code and/or current asthma therapy);
3. Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).

Exclusion Criteria:

1. Had any chronic respiratory disease, except asthma, at any time; and/or
2. Patients on maintenance oral steroids during baseline year

Primary outcomes:
measure: Proxy risk domain asthma control
timeFrame: One year outcome period
measure: Asthma exacerbation rate ratio
timeFrame: One year outcome period
Secondary outcomes:
measure: Overall asthma control
timeFrame: One year outcome period
measure: Hospitalisation rates
timeFrame: One year outcome period
measure: Treatment success
timeFrame: One year outcome period
measure: Adherence to ICS therapy
timeFrame: One year outcome period
measure: Use of short-acting beta2-agonist ("reliever") therapy
timeFrame: One year outcome period
Other outcomes:
Locations:
Study officials:
affiliation: Research in real life
name: David Price
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leach CL, Davidson PJ, Hasselquist BE, Boudreau RJ. Influence of particle size and patient dosing technique on lung deposition of HFA-beclomethasone from a metered dose inhaler. J Aerosol Med. 2005 Winter;18(4):379-85. doi: 10.1089/jam.2005.18.379.
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: Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002 Feb;19(2):246-51. doi: 10.1183/09031936.02.00218402.
citation: Newman SP, Weisz AW, Talaee N, Clarke SW. Improvement of drug delivery with a breath actuated pressurised aerosol for patients with poor inhaler technique. Thorax. 1991 Oct;46(10):712-6. doi: 10.1136/thx.46.10.712.
citation: Newman SP, Millar AB, Lennard-Jones TR, Moren F, Clarke SW. Improvement of pressurised aerosol deposition with Nebuhaler spacer device. Thorax. 1984 Dec;39(12):935-41. doi: 10.1136/thx.39.12.935.
citation: Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Respir J. 2009 Dec;18(4):243-9. doi: 10.4104/pcrj.2009.00029.
citation: Price D, Thomas M. Breaking new ground: challenging existing asthma guidelines. BMC Pulm Med. 2006 Nov 30;6 Suppl 1(Suppl 1):S6. doi: 10.1186/1471-2466-6-S1-S6.
citation: Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.