Qvar vs FP in Pediatrics

NCT01877954 | Completed DMC

• 1 other identifier: R02511
• Study Type: observational
• Target: 2,654
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

hydrofluoroalkane beclomethasone; fluticasone; paediatrics; real-life; observational; primary care

Outcome Measures

Primary Outcomes (2)

• Proxy risk domain asthma control

  Defined as the absence of the following during the one-year outcome period: 1. Asthma-related: * Hospital attendance or admission, OR * A\&E attendance, OR * Out of hours attendance, OR * Out-patient department attendance 2. GP consultations for lower respiratory tract infection 3. Prescriptions for acute courses of oral steroids .

  One year outcome period

• Asthma exacerbation rate ratio

  Where exacerbations are defined as an occurrence of: Defined as an occurrence of: 1. Asthma related: * Hospital admission, OR * A\&E attendance, OR 2. Use of acute oral steroids.

  One year outcome period

Secondary Outcomes (5)

• Overall asthma control

  One year outcome period

• Hospitalisation rates

  One year outcome period

• Treatment success

  One year outcome period

• Adherence to ICS therapy

  One year outcome period

• Use of short-acting beta2-agonist ("reliever") therapy

  One year outcome period

Study Arms (2)

IPDI Qvar

ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate

Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate

IPDI FP

ICS initiation as fluticasone propionate

Drug: Fluticasone propionate

Interventions

Extra-fine hydrofluoroalkane beclometasone dipropionate DRUG

Also known as: Qvar®

IPDI Qvar

Fluticasone propionate DRUG

IPDI FP

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Asthma patients who initiate ICS therapy as one of: HFA-BDP pMDI FP pMDI

You may qualify if:

• Aged: 5-11 years
• Evidence of asthma (diagnostic code and/or current asthma therapy);
• 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).

You may not qualify if:

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

Sponsors & Collaborators

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

Related Publications (8)

• 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.

  PMID: 16379614 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

• 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.

  PMID: 11866004 BACKGROUND

• 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.

  PMID: 1750017 BACKGROUND

• 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.

  PMID: 6440305 BACKGROUND

• 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.

  PMID: 19513494 BACKGROUND

• 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.

  PMID: 17140424 BACKGROUND

• 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.

  PMID: 20692026 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• David Price

  Research in real life

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 14, 2013
• Study Start: February 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 14, 2013

Record last verified: 2013-06