Device Mixing in Asthma, a General Practice Research Database Study

NCT01313585 | Completed DMC

• 1 other identifier: 003/10
• Study Type: observational
• Target: 815,377
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the absolute and relative effectiveness of asthma management in patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) - beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever medication (short-acting beta2-agonist \[SABA\] therapy) via either a BAI (i.e. Easi-breathe® \[EB\] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI salbutamol).

Conditions

Asthma

Keywords

Primary care; asthma management; inhaler device; maintenance therapy; reliever therapy; Easibreathe salbutamol

Outcome Measures

Primary Outcomes (2)

• Proxy asthma control

  Control defined as: * No recorded hospital attendance for asthma, including admission, Accident \& Emergency (A\&E) attendance, out-of-hours attendance, or Out-Patient Department (OPD) attendance, AND * No prescriptions for oral steroids, AND * No GP consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.

  One-year outcome period

• Total number of asthma exacerbations and exacerbation rate ratio

  Where exacerbation is defined as an occurrence of: * Unscheduled hospital admissions / A\&E attendance for asthma, OR * Use of oral steroids

  One-year outcome period

Secondary Outcomes (3)

• Treatment success 1

  One-year outcome period

• Treatment success 2 (independent of possible cost savings)

  One-year outcome period

• Respiratory-related hospitalisations and referrals.

  One-year outcome period

Study Arms (4)

IPDA salbutamol MDI

receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI

Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI

IPDA salbutamol EB

receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe

Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device

IPDI salbutamol EB

initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe

Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device

IPDI salbutamol MDI

initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI

Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device

Interventions

Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device DRUG

IPDI salbutamol EB

Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device DRUG

IPDI salbutamol MDI

Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device DRUG

IPDA salbutamol EB

Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI DRUG

IPDA salbutamol MDI

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthma patients on SABA therapy (any available) monotherapy who, at the index date, either: (i) IPDI: initiate ICS therapy as BDP EB at the index date and also receive reliever therapy as either\*: * Salbutamol EB, or * Salbutamol MDI, OR, who (ii) IPDA: receive a recorded increase in ICS therapy as BDP EB at the index date and also receive reliever therapy as either\*: * Salbutamol EB, or * Salbutamol MDI.

You may qualify if:

• Aged: 4-80 years:
• Paediatric cohort (aged 4-11 years), and
• Adult cohort (aged 12-80 years )
• Evidence of asthma:
• a diagnostic code for asthma, and / or
• ≥2 prescriptions for asthma at different points in time during the prior year and/ or
• ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS prescription (in addition to that received at IPD) - IPDI cohort only
• Be on current asthma therapy (for the IPDA cohort only):
• ≥1 ICS prescription in the prior year, and
• ≥1 other asthma prescription during the baseline year.
• Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the IPD).

You may not qualify if:

• had a COPD read code at any time; and/or
• received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or
• received a long-acting beta2-agonsist (LABA) in addition to a separate ICS inhaler in the baseline year
• received ICS therapy during baseline year via DPI (in IPDA cohort only).

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, United Kingdom

Location

Related Publications (11)

• 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

• Crompton GK, Barnes PJ, Broeders M, Corrigan C, Corbetta L, Dekhuijzen R, Dubus JC, Magnan A, Massone F, Sanchis J, Viejo JL, Voshaar T; Aerosol Drug Management Improvement Team. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med. 2006 Sep;100(9):1479-94. doi: 10.1016/j.rmed.2006.01.008. Epub 2006 Feb 21.

  PMID: 16495040 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

• 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

• Lenney J, Innes JA, Crompton GK. Inappropriate inhaler use: assessment of use and patient preference of seven inhalation devices. EDICI. Respir Med. 2000 May;94(5):496-500. doi: 10.1053/rmed.1999.0767.

  PMID: 10868714 BACKGROUND

• Molimard M, Raherison C, Lignot S, Depont F, Abouelfath A, Moore N. Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003 Fall;16(3):249-54. doi: 10.1089/089426803769017613.

  PMID: 14572322 BACKGROUND

• Brocklebank D, Ram F, Wright J, Barry P, Cates C, Davies L, Douglas G, Muers M, Smith D, White J. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. Health Technol Assess. 2001;5(26):1-149. doi: 10.3310/hta5260.

  PMID: 11701099 BACKGROUND

• Brocklebank D, Wright J, Cates C. Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering corticosteroids in asthma. BMJ. 2001 Oct 20;323(7318):896-900. doi: 10.1136/bmj.323.7318.896.

  PMID: 11668133 BACKGROUND

• Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.

  PMID: 15654001 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

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: March 10, 2011
• First Posted: March 14, 2011
• Study Start: January 1, 1991
• Primary Completion: June 1, 2007
• Study Completion: March 1, 2010
• Last Updated: March 14, 2011

Record last verified: 2011-03

Locations

GB (1)