Clinical trial NCT01400217: Qvar Versus Clenil, a General Practice Research Database Study
Official title: HFA Beclomethasone in Asthma, a General Practice Research Database Study: Real-life Observational Evaluation of Extra-fine With Standard Particle Size Beclometasone Dipropionate Using the Propellant Hydrofluoroalkane 134a for the Management of Asthma in a Representative UK Primary Care Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Primary Care
Particle size
beclomethasone dipropionate
Asthma Management
Maintenance Therapy
Metered-Dose Inhaler
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Teva Branded Pharmaceutical Products R&D, Inc.
First posted: 2011-07-22
Enrollment: 56985
Sex: ALL
Minimum age (years): 4
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients are aged between 4-80 years and have evidence of asthma and subsequent therapy.

Brief summary: This study will compare the absolute and relative effectiveness of asthma management in patients on inhaled corticosteroid (ICS) maintenance therapy as either extra-fine-particle or larger-particle formulation beclomethasone dipropionate (BDP) via metered-dose inhalers (MDIs) using the propellant hydrofluoroalkane propellant (HFA-BDP), namely Qvar® MDI compared with Clenil® MDI.

Detailed 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.

In response to the Montreal Protocol's ruling to phase out ozone-depleting chlorofluorocarbon (CFC) propellants in asthma inhalers, several hydrofluoroalkane-134a-propellant (HFA-) formulations of BDP have been developed. Two branded generic formulations currently available in the UK are Qvar® (Teva Pharmaceutical Industries Ltd) - an extra-fine-particle (\~1.1 microns) HFA-BDP (solution) formulation and Clenil® (Chiesi Limited) - a larger particle (\~2.9 microns) HFA-BDP (suspension) formulation.

The extra-fine particle formulation HFA-BDP formulation (Qvar®) has been shown to improve total and small airway deposition relative to CFC-BDP. As a result of the more even distribution through both the large and small airways of the lungs and data from short-term randomised clinical trials (RCTs), Qvar® dosing is recommended at approximately one half the dose of traditional CFC-BDP (average particle size \~3.5 microns). However, the larger-particle Clenil® is recommended for prescribing at the same dose as traditional CFC-BDP.

Further studies are required to understand whether the differences in particle size and airway distribution have an impact on asthma outcomes over the long-term.

This observational study will investigate the real-world effectiveness of extra-fine HFA-BDP (Qvar®) as compared with larger-particle HFA-BDP (Clenil®) in patients with asthma who: were new to ICS therapy; received an increase in their ICS dose, or switched / changed baseline ICS therapy to HFA-BDP with no change in BDP-equivalent ICS dose. We hypothesise that differences in effectiveness might become apparent over the longer term through a retrospective database analysis of one-year outcomes for the diverse patient population seen in primary care.

Eligibility criteria: Inclusion Criteria:

* Aged: 4-80 years
* Paediatric cohort (aged 4-11 years), and
* Adult cohort (aged 12-80 years )
* Evidence of asthma and current asthma therapy:
* All cohorts (IPDI, IPDS, IPDA):

  * a diagnostic code for asthma, and / or \*≥2 prescriptions for asthma at different points in time during the prior year and/or IPDI only: ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS prescription in addition to that received at IPD

IPDA and IPDS only:

* 1 ICS prescription in the baseline year, and
* 1 other asthma prescription during the baseline year.

  \*Evidence of "current therapy":
* 2 prescription for ICS during the outcome year (i.e. ≥1 prescription in addition to the prescription at index date

  * 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
* Had any chronic respiratory disease, except asthma, at any time; and/or
* Patients on maintenance oral steroids during baseline year
* Received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or
* Received ICS therapy during baseline year via DPI (IPDA and IPDS cohorts only).
* If they received multiple ICS prescriptions on the same day at IPD or immediately before

Primary outcomes:
measure: Severe asthma exacerbation (ATS/ERS based defn)
timeFrame: 1 year
measure: Primary composite asthma control
timeFrame: 1 year
Secondary outcomes:
measure: Exacerbation definition based on clinical experience
timeFrame: 1 year
measure: Asthma control + SABA usage
timeFrame: 1 year
measure: Treatment success
timeFrame: 1 year
measure: Asthma-related hospitalisations
timeFrame: 1 year
measure: Respiratory hospitalisations
timeFrame: 1 year
measure: SABA usage
timeFrame: 1 year
measure: ICS compliance
timeFrame: 1 year
measure: Oral Thrush
timeFrame: 1 year
Other outcomes:
Locations:
city: Cawston
country: United Kingdom
facility: Research in Real Life Ltd
state: Norfolk
Study officials:
affiliation: Company Director
name: David Price, MD
role: PRINCIPAL_INVESTIGATOR
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