Device Mixing in Asthma, a General Practice Research Database Study

Asthma Clinical Trial

— EBsalbutamol  

Official title:

Retrospective, Real-life Observational Evaluation of the Effectiveness of Mixed Maintenance and Reliever Inhaler Types in Patients in the Management of Asthma in a Representative UK Primary Care Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313585
• Other study ID #: 003/10
• Status: Completed
• Phase: N/A
• First received: March 10, 2011
• Last updated: March 11, 2011
• Start date: January 1991
• Est. completion date: March 2010

Study information

• Verified date: March 2011
• 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

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).

Description:

Current asthma guidelines in the UK are underpinned by evidence derived from randomised controlled trials (RCTs). Although RCT data are considered the gold standard, patients recruited to asthma RCTs are estimated to represent less than 10% of the UK's asthma population. The poor representation of the asthma population is due to a number of factors, such as tightly-controlled inclusion criteria for RCTs. There is, therefore, a need for more representative RCTs and real-life observational studies to inform existing guidelines and help optimise asthma outcomes.

Inhalation therapy is the cornerstone of asthma treatment, used for the delivery of 'reliever' bronchodilator therapy (e.g. salbutamol) as well as anti-inflammatory corticosteroid 'maintenance' or 'controller' therapy. Currently available inhaler devices include MDIs, breath-actuated MDIs (BAIs), and dry powder inhalers (DPIs). Both BAIs and DPIs are actuated by the patient's inhalation manoeuvre, while MDIs are actuated by the patient's pressing of a button, which must thus be coordinated with inhalation. The clinical effectiveness of inhalation therapy derives from delivery of drug to the target sites in the lungs, and evidence is mounting that suboptimal use of inhaler devices is a common problem contributing to compromised asthma control for many patients. Indeed, decreased asthma control has been linked to the number of mistakes when using MDIs for delivering inhaled corticosteroids (ICS).

There is also evidence that the ability of patients to use the different inhaler device types is variable. Nonetheless, recent reviews of RCTs, while recognising the importance of inhaler technique, have concluded that inhaler devices do not differ significantly in efficacy and that the cheapest inhaler device should be used. However, as results are based on RCTs they should be applied with care in light of the aforementioned issues around external validity of RCTs and the ability to extrapolate their findings across a broad patient population. Moreover, patients enrolled in RCTs typically receive extensive training and must demonstrate and maintain proper inhaler technique, seldom accomplished in a real-world setting.

The aim of this study is to compare the absolute and relative effectiveness of ICS (maintenance) plus SABA (reliever) therapy delivered via same-type devices (namely BDP via EB plus salbutamol via EB [BAI]) and that delivered via different device types (i.e. BDP via EB [BAI] plus SABA via MDI) in a real-life, representative, UK primary care asthma population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 815377
• Est. completion date: March 2010
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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).

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma

Intervention

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

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

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

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

Locations

Country	Name	City	State
United Kingdom	General Practice Research Database	London

Sponsors (2)

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

Country where clinical trial is conducted

United Kingdom, 

References & Publications (11)

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. — View Citation

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. Review. — View Citation

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. — View 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. Review. — View Citation

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. Epub 2006 Feb 21. Review. — View Citation

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. 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

Herland K, Akselsen JP, Skjønsberg 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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Nov 17. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Treatment success 1	Success: defined as: (i) Exacerbation: Unscheduled hospital admissions / A&E attendance for asthma, OR; Acute use of oral steroids; AND; (ii) No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics; AND; (iii) No change in therapeutic regimen: Increased dose of ICS, and/or; Change in ICS/LABA, and/or; Change in delivery device, and/or; Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs).	One-year outcome period	No
Secondary	Treatment success 2 (independent of possible cost savings)	Success: defined as: (i) Exacerbation: Unscheduled hospital admissions / A&E attendance for asthma, OR; Acute use of oral steroids; AND; (ii) No consultations, hospital admissions or A&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics; AND; (iii) No change in therapeutic regimen: Increased dose of ICS, and/or; Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs).	One-year outcome period	No
Secondary	Respiratory-related hospitalisations and referrals.	Mean number of respiratory-related hospitalisations and referrals per patient recorded during the one-year outcome period	One-year outcome period	Yes

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