Qvar Versus Clenil, a General Practice Research Database Study

Research in Real-Life

Status: Completed

Conditions: Asthma

Treatments: Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler; Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT01400217

007/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56,985 patients

Sex: All

Ages: 4 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

56,985 participants in 6 patient groups

IPDI EF HFA-BDP

Description:

Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date

Treatment:

Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

IPDI SP HFA-BDP

Description:

Patients initiating inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date

Treatment:

Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

IPDA SP HFA-BDP

Description:

Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date

Treatment:

Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

IPDA EF HFA-BDP

Description:

Patients increased inhaled corticosteroid therapy as extra fine particle HFA-BDP MDI at the index date

Treatment:

Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

IPDS SP HFA-BDP

Description:

Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date

Treatment:

Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

IPDS EF HFA-BDP

Description:

Patients increased inhaled corticosteroid therapy as extrafine particle HFA-BDP MDI at the index date

Treatment:

Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler