AsthmaNCT01400217
Qvar Versus Clenil, a General Practice Research Database Study
An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler and standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
- How many people
- 56,985 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 1991to Oct 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 4 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients are aged between 4-80 years and have evidence of asthma and subsequent therapy.
Who may be able to join
- 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
Show all 12Show fewer
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Research in Real Life Ltd
Cawston, Norfolk, NR10 4FE
About this 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
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.
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, 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.
- Conditions
- Asthma
- Being tested
- extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler, standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler
- Keywords
- Primary Care, Particle size, beclomethasone dipropionate, Asthma Management, Maintenance Therapy, Metered-Dose Inhaler
- 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 particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerDrug
Also called Qvar
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
standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerDrug
Also called Fostair
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
| Study group | Role | What they receive |
|---|---|---|
| IPDI EF HFA-BDP | Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe asthma exacerbation (ATS/ERS based defn)
Exacerbation defined as:
(i) Respiratory-related:
- Hospital attendance / admissions OR
- A\&E attendance OR (ii) Use of acute oral steroids**
Measured: 1 year
Primary composite asthma control
Where control is defined as absence of:
(i) Respiratory-related:
- Hospital attendance or admission
- A\&E attendance, OR
- Out of hours attendance, OR
- Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids
Measured: 1 year
Secondary outcomes (8)
Exacerbation definition based on clinical experience
Defined as:
(i) Respiratory-related:
- Hospital attendance / admissions OR
- A\&E attendance OR
- Out of hours consultation OR
- GP consultation OR (ii) Use of acute oral steroids
Measured: 1 year
Asthma control + SABA usage
Where control requires the absence of:
(i) Respiratory-related:
- Hospital attendance or admission
- A\&E attendance, OR
- Out of hours consultation, OR
- 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
Measured: 1 year
Treatment success
(i) Control
- 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
- Increased dose of ICS (≥50% increase), and/or
- Change in ICS and/or
- Change in delivery device, and/or
- Use of additional therapy as defined by: LABA, theophylline, leukotreine receptor antagonists (LTRAs).
Measured: 1 year
Asthma-related hospitalisations
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
Measured: 1 year
Respiratory hospitalisations
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
Measured: 1 year
SABA usage
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.
Measured: 1 year
ICS compliance
Based on prescription refills
Measured: 1 year
Oral Thrush
Defined as:
(i) Topical oral anti-fungal prescriptions, and / or (ii) Coded for oral candidiasis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJan 1991
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 56,985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Responsible party
- Principal investigator, David Price, Research in Real-Life Ltd
- Investigators
- David Price, MD, Principal investigator, Company Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400217
- Sponsor's protocol ID
- 007/11
- Status last verified
- Oct 2012
- First submitted
- 20 Jul 2011
- Last updated
- 30 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 15672843Travers 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 17113277Appleton 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 16275363Vanden 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.
PubMed 11112914Leach 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.
PubMed 16379614Leach 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.
PubMed 9877489Busse 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.
PubMed 10589004Davies 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.
PubMed 9850360Gross 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 10027430IBM SPSS Statistics. 2010. Statistics family. Available online at: www.spss.com/uk/software/statistics/
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
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.
PubMed 23643486
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01400217
- Acronym / sponsor ID
- 007/11
- Conditions
- Asthma
- Keywords
- Primary Care, Particle size, beclomethasone dipropionate, Asthma Management, Maintenance Therapy, Metered-Dose Inhaler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56,985 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Jan 1991
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IPDI EF HFA-BDP | – | Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerPatients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date |
| IPDI SP HFA-BDP | – | Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerPatients initiating inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date |
| IPDA SP HFA-BDP | – | Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerPatients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date |
| IPDA EF HFA-BDP | – | Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerPatients increased inhaled corticosteroid therapy as extra fine particle HFA-BDP MDI at the index date |
| IPDS SP HFA-BDP | – | Drug: standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerPatients increased inhaled corticosteroid therapy as standard particle HFA-BDP MDI at the index date |
| IPDS EF HFA-BDP | – | Drug: extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerPatients increased inhaled corticosteroid therapy as extrafine particle HFA-BDP MDI at the index date |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients are aged between 4-80 years and have evidence of asthma and subsequent therapy.
Key inclusion criteria (12 listed)
- 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):
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerAlso: QvarIPDI 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 | Drug | IPDA EF HFA-BDP, IPDI EF HFA-BDP, IPDS EF HFA-BDP |
| standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhalerAlso: FostairIPDI 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 | Drug | IPDA SP HFA-BDP, IPDI SP HFA-BDP, IPDS SP HFA-BDP |
Primary outcome
Severe asthma exacerbation (ATS/ERS based defn)
Time frame: 1 year
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
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
8 secondary outcomes
Exacerbation definition based on clinical experience
Time frame: 1 year
Asthma control + SABA usage
Time frame: 1 year
Treatment success
Time frame: 1 year
Asthma-related hospitalisations
Time frame: 1 year
Respiratory hospitalisations
Time frame: 1 year
SABA usage
Time frame: 1 year
ICS compliance
Time frame: 1 year
Oral Thrush
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
- Background: PubMed 15672843Herland 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.
- Background: PubMed 17113277Travers 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.
- Background: PubMed 16275363Appleton 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.
- Background: PubMed 11112914Vanden 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.
- Background: PubMed 16379614Leach 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.
- Background: PubMed 9877489Leach 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.
- Background: PubMed 10589004Busse 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.
- Background: PubMed 9850360Davies 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.
- Background: PubMed 10027430Gross 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.
- BackgroundIBM SPSS Statistics. 2010. Statistics family. Available online at: www.spss.com/uk/software/statistics/
- BackgroundAS Institute Inc. 2010. Statistical Analysis with SAS/STAT Software. Available online at: www.SAS.com/offices/europe/uk/technologies/analytics/statistics/stat/ondex.html
- Derived from this study: PubMed 23643486Price 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Price, MD principal investigator
Company Director
1 site in 1 country: see every site and its status.
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 12 inclusion and 6 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 30 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?
Severe asthma exacerbation (ATS/ERS based defn) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01400217, which also lists 12 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 30 Oct 2012; AzTrials last refreshed its copy on 30 Oct 2026.