AsthmaNCT01877954
Qvar vs FP in Pediatrics
An observational study of Asthma, run by Research in Real-Life Ltd.
Trial summary
The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Extra-fine hydrofluoroalkane beclometasone dipropionate and Fluticasone propionate
- How many people
- 2,654 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Mar 2013
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Asthma patients who initiate ICS therapy as one of: HFA-BDP pMDI FP pMDI
Who may be able to join
- Aged: 5-11 years
- Evidence of asthma (diagnostic code and/or current asthma therapy);
- Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).
Who cannot join
- Had any chronic respiratory disease, except asthma, at any time; and/or
- Patients on maintenance oral steroids during baseline year
About this study
Official title: Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population
The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.
Read the detailed description
Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:
- Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
- Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.
- Conditions
- Asthma
- Being tested
- Extra-fine hydrofluoroalkane beclometasone dipropionate, Fluticasone propionate
- Keywords
- hydrofluoroalkane beclomethasone, fluticasone, paediatrics, real-life, observational, primary care
- 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®
Fluticasone propionateDrug
| Study group | Role | What they receive |
|---|---|---|
| IPDI Qvar | ICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate Receives: Drug: Extra-fine hydrofluoroalkane beclometasone dipropionate | |
| IPDI FP | ICS initiation as fluticasone propionate Receives: Drug: Fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proxy risk domain asthma control
Defined as the absence of the following during the one-year outcome period:
- Asthma-related:
- Hospital attendance or admission, OR
- A\&E attendance, OR
- Out of hours attendance, OR
- Out-patient department attendance
- GP consultations for lower respiratory tract infection
- Prescriptions for acute courses of oral steroids .
Measured: One year outcome period
Asthma exacerbation rate ratio
Where exacerbations are defined as an occurrence of:
Defined as an occurrence of:
- Asthma related:
- Hospital admission, OR
- A\&E attendance, OR
- Use of acute oral steroids.
Measured: One year outcome period
Secondary outcomes (5)
Overall asthma control
Risk domain asthma control as defined above, plus
(a)Average prescribed daily dose of albuterol or terbutaline of ≤200mg
Measured: One year outcome period
Hospitalisation rates
Asthma-related hospitalisations
- Definite: Hospitalisations coded with an asthma read code
- Definite and probable: Hospitalisations with an asthma read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of an asthma read code
Respiratory hospitalisations
- Definite: Hospitalisations coded with a lower respiratory code
- Definite and probable: Hospitalisations with a lower respiratory read code and uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code
Measured: One year outcome period
Treatment success
Asthma control and no change in therapy
Measured: One year outcome period
Adherence to ICS therapy
Categorised as: <50%, 50-<70%, 70-<100%, ≥100%.
Measured: One year outcome period
Use of short-acting beta2-agonist ("reliever") therapy
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.
- First posted14 Jun 2013 (estimated)
- Study startFeb 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,654 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
- Sponsor
- Investigators
- David Price, Principal investigator, Research in real life
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877954
- Sponsor's protocol ID
- R02511
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2013
- Last updated
- 14 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
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 9877489Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002 Feb;19(2):246-51. doi: 10.1183/09031936.02.00218402.
PubMed 11866004Newman SP, Weisz AW, Talaee N, Clarke SW. Improvement of drug delivery with a breath actuated pressurised aerosol for patients with poor inhaler technique. Thorax. 1991 Oct;46(10):712-6. doi: 10.1136/thx.46.10.712.
PubMed 1750017Newman SP, Millar AB, Lennard-Jones TR, Moren F, Clarke SW. Improvement of pressurised aerosol deposition with Nebuhaler spacer device. Thorax. 1984 Dec;39(12):935-41. doi: 10.1136/thx.39.12.935.
PubMed 6440305Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Respir J. 2009 Dec;18(4):243-9. doi: 10.4104/pcrj.2009.00029.
PubMed 19513494Price D, Thomas M. Breaking new ground: challenging existing asthma guidelines. BMC Pulm Med. 2006 Nov 30;6 Suppl 1(Suppl 1):S6. doi: 10.1186/1471-2466-6-S1-S6.
PubMed 17140424Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.
PubMed 20692026
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population
- ClinicalTrials.gov ID
- NCT01877954
- Acronym / sponsor ID
- R02511
- Conditions
- Asthma
- Keywords
- hydrofluoroalkane beclomethasone, fluticasone, paediatrics, real-life, observational, primary care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,654 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Feb 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 Jun 2013 (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.
The primary aim of this study was to compare the absolute and relative effectiveness of asthma management in paediatric patients in the UK on inhaled corticosteroid (ICS) maintenance therapy as extra-fine HFA-BDP (Qvar®) pressurised metered dose inhaler (pMDI) compared with fluticasone propionate (FP) pMDI.
Detailed description
Comparison of asthma control with extrafine-particle hydrofluoroalkane-beclometasone (EF HFA-BDP) vs fluticasone propionate (FP) in paediatric patients (5-11year olds). Patients identified from the General Practice Research Database (GPRD) and the Optimum Patient Care Research Database (OPCRD). Two analyses were conducted:
- Comparison of outcomes achieved by EF HFA-BDP and FP in 5-6year old patients with those achieved in 7-11yr old patients.
- Comparison of outcomes achieved by EF HFA-BDP used with or without a spacer to those achieved by standard particle fluticasone propionate (FP) used with a spacer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPDI Qvar | – | Drug: Extra-fine hydrofluoroalkane beclometasone dipropionateICS initiation as Extra-fine hydrofluoroalkane beclometasone dipropionate |
| IPDI FP | – | Drug: Fluticasone propionateICS initiation as fluticasone propionate |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Asthma patients who initiate ICS therapy as one of: HFA-BDP pMDI FP pMDI
Key inclusion criteria (3 listed)
- Aged: 5-11 years
- Evidence of asthma (diagnostic code and/or current asthma therapy);
- Have at least one year of up-to-standard (UTS) baseline data (during which the step-up to FP/SAL occurred) and at least one year of UTS outcome data (following the IPD).
Key exclusion criteria (2 listed)
- Had any chronic respiratory disease, except asthma, at any time; and/or
- Patients on maintenance oral steroids during baseline year
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 hydrofluoroalkane beclometasone dipropionateAlso: Qvar® | Drug | IPDI Qvar |
| Fluticasone propionate | Drug | IPDI FP |
Primary outcome
Proxy risk domain asthma control
Time frame: One year outcome period
Defined as the absence of the following during the one-year outcome period: 1. Asthma-related: * Hospital attendance or admission, OR * A\&E attendance, OR * Out of hours attendance, OR * Out-patient department attendance 2. GP consultations for lower respiratory tract infection 3. Prescriptions for acute courses of oral steroids .
Asthma exacerbation rate ratio
Time frame: One year outcome period
Where exacerbations are defined as an occurrence of: Defined as an occurrence of: 1. Asthma related: * Hospital admission, OR * A\&E attendance, OR 2. Use of acute oral steroids.
5 secondary outcomes
Overall asthma control
Time frame: One year outcome period
Hospitalisation rates
Time frame: One year outcome period
Treatment success
Time frame: One year outcome period
Adherence to ICS therapy
Time frame: One year outcome period
Use of short-acting beta2-agonist ("reliever") therapy
Time frame: One year outcome period
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 14 Jun 2013.
- 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 11866004Giraud V, Roche N. Misuse of corticosteroid metered-dose inhaler is associated with decreased asthma stability. Eur Respir J. 2002 Feb;19(2):246-51. doi: 10.1183/09031936.02.00218402.
- Background: PubMed 1750017Newman SP, Weisz AW, Talaee N, Clarke SW. Improvement of drug delivery with a breath actuated pressurised aerosol for patients with poor inhaler technique. Thorax. 1991 Oct;46(10):712-6. doi: 10.1136/thx.46.10.712.
- Background: PubMed 6440305Newman SP, Millar AB, Lennard-Jones TR, Moren F, Clarke SW. Improvement of pressurised aerosol deposition with Nebuhaler spacer device. Thorax. 1984 Dec;39(12):935-41. doi: 10.1136/thx.39.12.935.
- Background: PubMed 19513494Chrystyn H, Price D. Not all asthma inhalers are the same: factors to consider when prescribing an inhaler. Prim Care Respir J. 2009 Dec;18(4):243-9. doi: 10.4104/pcrj.2009.00029.
- Background: PubMed 17140424Price D, Thomas M. Breaking new ground: challenging existing asthma guidelines. BMC Pulm Med. 2006 Nov 30;6 Suppl 1(Suppl 1):S6. doi: 10.1186/1471-2466-6-S1-S6.
- Results publication: PubMed 20692026Price D, Martin RJ, Barnes N, Dorinsky P, Israel E, Roche N, Chisholm A, Hillyer EV, Kemp L, Lee AJ, von Ziegenweidt J, Colice G. Prescribing practices and asthma control with hydrofluoroalkane-beclomethasone and fluticasone: a real-world observational study. J Allergy Clin Immunol. 2010 Sep;126(3):511-8.e1-10. doi: 10.1016/j.jaci.2010.06.040. Epub 2010 Aug 9.
- Related InfoLink provided by the sponsor.
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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 principal investigator
Research in real life
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Research in Real-Life Ltd.
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 3 inclusion and 2 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 14 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
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 risk domain asthma control (time frame: One year outcome period). 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 NCT01877954, 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 14 Jun 2013.