Qvar Versus Clenil, a General Practice Research Database Study

This study has been completed.
Sponsor:
Collaborator:
Teva Pharmaceutical Industries
Information provided by (Responsible Party):
David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier:
NCT01400217
First received: July 20, 2011
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Asthma
Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Research in Real-Life Ltd:

Primary Outcome Measures:
  • Severe asthma exacerbation (ATS/ERS based defn) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Exacerbation defined as:

    (i) Respiratory-related:

    1. Hospital attendance / admissions OR
    2. A&E attendance OR (ii) Use of acute oral steroids**

  • Primary composite asthma control [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Where control is defined as absence of:

    (i) Respiratory-related:

    1. Hospital attendance or admission
    2. A&E attendance, OR
    3. Out of hours attendance, OR
    4. Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids


Secondary Outcome Measures:
  • Exacerbation definition based on clinical experience [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Defined as:

    (i) Respiratory-related:

    1. Hospital attendance / admissions OR
    2. A&E attendance OR
    3. Out of hours consultation OR
    4. GP consultation OR (ii) Use of acute oral steroids

  • Asthma control + SABA usage [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Where control requires the absence of:

    (i) Respiratory-related:

    1. Hospital attendance or admission
    2. A&E attendance, OR
    3. Out of hours consultation, OR
    4. Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids (iv) Average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline

  • Treatment success [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    (i) Control

    a. No respiratory-related: i. Hospital attendance or admission ii. A&E attendance, OR iii. Out of hours consultation, OR iv. Out-patient department attendance b. No GP consultations for lower respiratory tract infection (ii) No prescriptions for acute courses of oral steroids (iii) No additional or change in therapy

    1. Increased dose of ICS (≥50% increase), and/or
    2. Change in ICS and/or
    3. Change in delivery device, and/or
    4. Use of additional therapy as defined by: LABA, theophylline, leukotreine receptor antagonists (LTRAs).

  • Asthma-related hospitalisations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Defined as sum of:

    (i) Definite: Hospitalisations coded with an asthma read code (ii) Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code


  • Respiratory hospitalisations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Defined as the sum of:

    (i) Definite: Hospitalisations coded with a lower respiratory code (ii) Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code


  • SABA usage [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Average daily dosage during outcome year - outcome SABA usage will be categorised within ranges used to match baseline SABA use to optimise matching of the treatment arms.

  • ICS compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Based on prescription refills

  • Oral Thrush [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    Defined as:

    (i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis



Enrollment: 56985
Study Start Date: January 1991
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IPDI EF HFA-BDP
Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date
Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Other Name: Qvar
IPDI SP HFA-BDP
Patients initiating inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Other Name: Fostair
IPDA SP HFA-BDP
Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Other Name: Fostair
IPDA EF HFA-BDP
Patients increased inhaled corticosteroid therapy as extra fine particle HFA-BDP MDI at the index date
Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Other Name: Qvar
IPDS SP HFA-BDP
Patients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date
Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Other Name: Fostair
IPDS EF HFA-BDP
Patients increased inhaled corticosteroid therapy as extrafine particle HFA-BDP MDI at the index date
Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
Other Name: Qvar

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

Ages Eligible for Study:   4 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients are aged between 4-80 years and have evidence of asthma and subsequent therapy.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400217

Locations
United Kingdom
Research in Real Life Ltd
Cawston, Norfolk, United Kingdom, NR10 4FE
Sponsors and Collaborators
Research in Real-Life Ltd
Teva Pharmaceutical Industries
Investigators
Principal Investigator: David Price, MD Company Director
  More Information

Additional Information:
Publications:

Responsible Party: David Price, Professor David Price, Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT01400217     History of Changes
Other Study ID Numbers: 007/11
Study First Received: July 20, 2011
Last Updated: October 29, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Research in Real-Life Ltd:
Primary Care
Particle size
beclomethasone dipropionate
Asthma Management
Maintenance Therapy
Metered-Dose Inhaler

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 18, 2014