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AsthmaQvarvsComboNCT01697722

Real-world Effectiveness and Cost-effectiveness of HFA-beclometasone Compared With ICS/LABA Combination Therapy

An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of asthma management in patients with evidence of persistent asthma following an increase in asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS) using extrafine… Read more about this study

Who is it for?
Ages 5 to 80 years
Conditions the study is for
Asthma
What is being tested?
Extra-fine hydrofluoroalkane-beclometasone dipropionate and ICS / LABA via separate pMDI and / or BAI inhalers
How many people
815,377 participants
Where
1 siteUnited Kingdom
Study dates
Jan 1991to Feb 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Primary care asthma patients who were receiving ICS therapy (any of BDP, extrafine BDP-HFA, BUD or FP as pMDI or BAI) who, at an index prescription date, underwent either: (i) an increase in ICS as extrafine HFA-BDP (pMDI or BAI); (ii) a change to combination therapy with a separate LABA pMDI or BAI (no change in drug, device or daily BDP-equivalent dose) (iii) a change to combination therapy via a fixed-combination inhaler (with no increase in daily BDP-equivalent dose).

Who may be able to join

  • Aged: 4-60 years:
  • Paediatric cohort (aged 4-11 years), and
  • Adult cohort (aged 12-60 years)
  • Aged 61-80 years and never smoked for an additional elderly cohort;
  • Evidence of asthma: i.e. a diagnostic code of asthma or at least 2 asthma prescriptions, including one ICS prescription, at different points in time during the year prior to IPD (the baseline year)
  • Be on current asthma therapy: i.e. at least 1 asthma prescription in the year prior to IPD, and at least 1 other asthma prescription during the same period
  • 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).

Who cannot join

  • had a diagnostic read code for chronic obstructive pulmonary disease (COPD) at any time
  • had a diagnostic read code for chronic respiratory disease at any time (other than asthma)
  • any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • General Practice Research Database

    London, London

Other trials in United Kingdom

About this study

Official title: A Retrospective Evaluation of Effectiveness and Cost-effectiveness of Extrafine HFA-BDP Compared With Combination ICS/LABA Therapy in the Management of Asthma in a Representative Population of UK Primary Care Patients

This study will compare the effectiveness, cost-effectiveness and direct healthcare costs of asthma management in patients with evidence of persistent asthma following an increase in asthma therapy in the form of either an increased dose of inhaled glucocorticosteroids (ICS) using extrafine hydrofluoroalkane-beclometasone dipropionate (HFA-BDP) via pressurised metered-dose inhaler (pMDI) or breath-actuated inhaler (BAI), or a change to combination ICS plus long-acting bronchodilator (LABA) therapy using fixed combinations (fluticasone propionate / salmeterol [FP/SAL] or budesonide / formoterol [BUD/FOR]) or separate pMDIs and BAIs.

Read the 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, the patients recruited to asthma RCTs are estimated to represent less than 10% of the United Kingdom's (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.

The fixed combination asthma inhalers, FP/SAL (Seretide) and BUD/FOR (Symbicort) are indicated for use in asthma when adequate asthma control is not achieved with low/medium dose ICS therapy and as-needed (prn) reliever therapy (a short-acting beta-agonist [SABA]). Fixed combination inhalers are also indicated in patients already adequately controlled on separate ICS/LABA therapy. However, emerging trends in asthma prescribing indicate increasing use of add-on therapies (particularly in the form of combination inhalers) in the early stages of asthma therapy, even as first-line therapy.

In practice, there is significant pressure (supported by asthma guidelines) to use the least expensive, effective inhaled therapies available. While the effect of increased use of add-on and combination therapies in terms of patient benefits remains uncertain, the impact on the UK's National Health Service (NHS) treatment costs is unequivocal.

Short, randomised trials of the effectiveness of asthma monotherapies have demonstrated that extrafine HFA-BDP is at least as effective at half the dose as BDP pMDI, and equivalent to same-dose FP pMDI. There is also evidence to suggest that extrafine HFA-BDP optimises deposition in the lung and affords greater tolerance of poor coordination of breathing and inhaler actuation. In addition, one long-term, prospective, randomised, open-labelled trial comparing extrafine HFA-BDP with BDP over the course of one year demonstrated greater improvements in symptom-free days and quality of life in the extrafine HFA-BDP treatment group, at a lower cost per symptom-free day.

The hypothesis for this study, therefore, is that extrafine HFA-BDP may be a suitable, and cost-effective, alternative to combination therapy (as fixed or separate inhalers) in children and adults with evidence of persistent asthma.

Conditions
Asthma
Being tested
Extra-fine hydrofluoroalkane-beclometasone dipropionate, ICS / LABA via separate pMDI and / or BAI inhalers
Keywords
Primary care, Asthma management, Inhaled corticosteroids, Extra-fine hydrofluoroalkane, Long-acting beta-agonist, Fixed-dose combination therapy
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extra-fine hydrofluoroalkane-beclometasone dipropionateDrug

    Also called Qvar

    Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI

  • ICS / LABA via separate pMDI and / or BAI inhalersDrug

    Also called ICS+LABA separates

    A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose

Study groups in NCT01697722
Study groupRoleWhat they receive
Step-up as FDC ICS/LABAICS asthma patients who increased therapy as FDC ICS/LABA (no increase in daily ICS dose).
Step up as separate therapiesICS asthma patients who increased therapy as ICS / LABA via separate pMDI and / or BAI inhalers (no increase in daily ICS dose).
Receives: Drug: ICS / LABA via separate pMDI and / or BAI inhalers
Qvar step-upICS asthma patients who increased therpy as extra-fine hydrofluoroalkane-beclometasone dipropionate
Receives: Drug: Extra-fine hydrofluoroalkane-beclometasone dipropionate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proxy asthma control

    • 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 steroid, AND
    • No consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics

    Measured: One-year outcome period

Secondary outcomes (4)

  1. Success of therapeutic regimen

    Defined as the absence of (i) Exacerbation:

    1. Unscheduled hospital admissions / A\&E attendance for asthma, OR
    2. Acute use of oral steroids

    AND

    (ii) No consultations, hospital admissions or A\&E attendance for LRTI requiring antibiotics

    AND

    (iii) No change in therapeutic regimen:

    1. Increased dose of ICS, and/or
    2. Change in ICS/LABA, and/or
    3. Change in delivery device, and/or
    4. Use of additional therapy as defined by: theophylline, LTRAs, oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).

    Measured: One-year outcome period

  2. Success of therapeutic regimen (sensitivity - independent of cost saving)

    Success: defined as the absence of

    (i) Exacerbation:

    1. Unscheduled hospital admissions / A\&E attendance for asthma, OR
    2. 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:

    1. Increased dose of ICS, and/or
    2. Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs), oral beta agonists (or LABAs in patients receiving extrafine HFA-BDP).

    Measured: One-year outcome period

  3. average SABA daily dose during outcome year

    Average daily dose categorised as: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg).

    Measured: One-year outcome period

  4. Hospitalisations

    Mean number of asthma and respiratory-related hospitalisations recorded per patient during the outcome year

    Measured: One-year outcome period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2012 (estimated)
  2. Study startJan 1991
  3. Primary completionJun 2007
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
815,377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01697722
Sponsor's protocol ID
BA21
Acronym
QvarvsCombo
Status last verified
Oct 2012
First submitted
28 Sep 2012
Last updated
4 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15672843

  • 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.

    PubMed 17113277

  • 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.

    PubMed 16275363

  • Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. National Heart, Lung, and Blood Institute, National Institutes of Health, 2007. (Accessed March 2008, at http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf

  • Aubier M, Wettenger R, Gans SJ. Efficacy of HFA-beclomethasone dipropionate extra-fine aerosol (800 microg day(-1)) versus HFA-fluticasone propionate (1000 microg day(-1)) in patients with asthma. Respir Med. 2001 Mar;95(3):212-20. doi: 10.1053/rmed.2000.1025.

    PubMed 11266239

  • Fairfax A, Hall I, Spelman R. A randomized, double-blind comparison of beclomethasone dipropionate extrafine aerosol and fluticasone propionate. Ann Allergy Asthma Immunol. 2001 May;86(5):575-82. doi: 10.1016/S1081-1206(10)62907-9.

    PubMed 11379810

  • Lasserson TJ, Cates CK, Jones AB, Steele EH, White J. Fluticasone versus HFA-beclomethasone dipropionate for chronic asthma in adults and children. Cochrane Database Syst Rev. 2006 Apr 19;2006(2):CD005309. doi: 10.1002/14651858.CD005309.pub3.

    PubMed 16625634

  • Gross G, Thompson PJ, Chervinsky P, Vanden Burgt J. Hydrofluoroalkane-134a beclomethasone dipropionate, 400 microg, is as effective as chlorofluorocarbon beclomethasone dipropionate, 800 microg, for the treatment of moderate asthma. Chest. 1999 Feb;115(2):343-51. doi: 10.1378/chest.115.2.343.

    PubMed 10027430

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proxy asthma control (time frame: One-year outcome period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01697722, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.

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