Qvar Versus Clenil, a General Practice Research Database Study

NCT01400217 | Completed DMC

• 1 other identifier: 007/11
• Study Type: observational
• Target: 56,985
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Primary Care; Particle size; beclomethasone dipropionate; Asthma Management; Maintenance Therapy; Metered-Dose Inhaler

Outcome Measures

Primary Outcomes (2)

• Severe asthma exacerbation (ATS/ERS based defn)

  Exacerbation defined as: (i) Respiratory-related: 1. Hospital attendance / admissions OR 2. A\&E attendance OR (ii) Use of acute oral steroids\*\*

  1 year

• Primary composite asthma control

  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

  1 year

Secondary Outcomes (8)

• Exacerbation definition based on clinical experience

  1 year

• Asthma control + SABA usage

  1 year

• Treatment success

  1 year

• Asthma-related hospitalisations

  1 year

• Respiratory hospitalisations

  1 year

Study Arms (6)

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 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

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

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

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

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

Interventions

extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler DRUG

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

Also known as: Qvar

IPDA EF HFA-BDP; IPDI EF HFA-BDP; IPDS EF HFA-BDP

standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler DRUG

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

Also known as: Fostair

IPDA SP HFA-BDP; IPDI SP HFA-BDP; IPDS SP HFA-BDP

Eligibility Criteria

• Age: 4 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• ICS prescription in the baseline year, and
• other asthma prescription during the baseline year.
• \*Evidence of "current therapy":
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Research in Real-Life Ltd: lead
• Teva Branded Pharmaceutical Products R&D, Inc.: collaborator

Study Sites (1)

Research in Real Life Ltd

Cawston, Norfolk, NR10 4FE, United Kingdom

Location

Related Publications (12)

• 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.

  PMID: 15672843 BACKGROUND

• 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.

  PMID: 17113277 BACKGROUND

• 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.

  PMID: 16275363 BACKGROUND

• Vanden Burgt JA, Busse WW, Martin RJ, Szefler SJ, Donnell D. Efficacy and safety overview of a new inhaled corticosteroid, QVAR (hydrofluoroalkane-beclomethasone extrafine inhalation aerosol), in asthma. J Allergy Clin Immunol. 2000 Dec;106(6):1209-26. doi: 10.1067/mai.2000.111582.

  PMID: 11112914 BACKGROUND

• Leach CL, Davidson PJ, Hasselquist BE, Boudreau RJ. Influence of particle size and patient dosing technique on lung deposition of HFA-beclomethasone from a metered dose inhaler. J Aerosol Med. 2005 Winter;18(4):379-85. doi: 10.1089/jam.2005.18.379.

  PMID: 16379614 BACKGROUND

• Leach CL, Davidson PJ, Boudreau RJ. Improved airway targeting with the CFC-free HFA-beclomethasone metered-dose inhaler compared with CFC-beclomethasone. Eur Respir J. 1998 Dec;12(6):1346-53. doi: 10.1183/09031936.98.12061346.

  PMID: 9877489 BACKGROUND

• Busse WW, Brazinsky S, Jacobson K, Stricker W, Schmitt K, Vanden Burgt J, Donnell D, Hannon S, Colice GL. Efficacy response of inhaled beclomethasone dipropionate in asthma is proportional to dose and is improved by formulation with a new propellant. J Allergy Clin Immunol. 1999 Dec;104(6):1215-22. doi: 10.1016/s0091-6749(99)70016-3.

  PMID: 10589004 BACKGROUND

• Davies RJ, Stampone P, O'Connor BJ. Hydrofluoroalkane-134a beclomethasone dipropionate extrafine aerosol provides equivalent asthma control to chlorofluorocarbon beclomethasone dipropionate at approximately half the total daily dose. Respir Med. 1998 Jun;92 Suppl A:23-31. doi: 10.1016/s0954-6111(98)90214-1.

  PMID: 9850360 BACKGROUND

• 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.

  PMID: 10027430 BACKGROUND

• IBM SPSS Statistics. 2010. Statistics family. Available online at: www.spss.com/uk/software/statistics/

  BACKGROUND

• AS Institute Inc. 2010. Statistical Analysis with SAS/STAT Software. Available online at: www.SAS.com/offices/europe/uk/technologies/analytics/statistics/stat/ondex.html

  BACKGROUND

• Price D, Thomas M, Haughney J, Lewis RA, Burden A, von Ziegenweidt J, Chisholm A, Hillyer EV, Corrigan CJ. Real-life comparison of beclometasone dipropionate as an extrafine- or larger-particle formulation for asthma. Respir Med. 2013 Jul;107(7):987-1000. doi: 10.1016/j.rmed.2013.03.009. Epub 2013 May 3.

  PMID: 23643486 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• David Price, MD

  Company Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor David Price

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: January 1, 1991
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 30, 2012

Record last verified: 2012-10

Locations

GB (1)