Qvar vs FP in Pediatrics

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877954
• Other study ID #: R02511
• Status: Completed
• Phase: N/A
• First received: June 12, 2013
• Last updated: June 13, 2013
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2654
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 11 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Extra-fine hydrofluoroalkane beclometasone dipropionate

• Fluticasone propionate

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

References & Publications (8)

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. Review. — View 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. — 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

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. — View Citation

Newman SP, Millar AB, Lennard-Jones TR, Morén F, Clarke SW. Improvement of pressurised aerosol deposition with Nebuhaler spacer device. Thorax. 1984 Dec;39(12):935-41. — View 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. — View 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 st — View Citation

Price D, Thomas M. Breaking new ground: challenging existing asthma guidelines. BMC Pulm Med. 2006 Nov 30;6 Suppl 1:S6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proxy risk domain asthma control	Defined as the absence of the following during the one-year outcome period: Asthma-related: Hospital attendance or admission, OR; A&E attendance, OR; Out of hours attendance, OR; Out-patient department attendance; GP consultations for lower respiratory tract infection; Prescriptions for acute courses of oral steroids .	One year outcome period	No
Primary	Asthma exacerbation rate ratio	Where exacerbations are defined as an occurrence of: Defined as an occurrence of: Asthma related: Hospital admission, OR; A&E attendance, OR; Use of acute oral steroids.	One year outcome period	No
Secondary	Overall asthma control	Risk domain asthma control as defined above, plus; (a)Average prescribed daily dose of albuterol or terbutaline of =200mg	One year outcome period	No
Secondary	Hospitalisation rates	Asthma-related hospitalisations; Definite: Hospitalisations coded with an asthma read code; Definite and probable: Hospitalisations with an asthma read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code; Respiratory hospitalisations; Definite: Hospitalisations coded with a lower respiratory code; Definite and probable: Hospitalisations with a lower respiratory read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code	One year outcome period	No
Secondary	Treatment success	Asthma control and no change in therapy	One year outcome period	No
Secondary	Adherence to ICS therapy	Categorised as: <50%, 50-<70%, 70-<100%, =100%.	One year outcome period	No
Secondary	Use of short-acting beta2-agonist ("reliever") therapy		One year outcome period	No

External Links

•   Link