AsthmaNCT01729351
Qvar Therapy in Smoking Asthmatics
An observational study of Asthma and Smoking, run by Research in Real-Life Ltd.
Trial summary
To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care asthma population of current smokers. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- How many people
- 7,195 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jun 2012
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are all current smokers ages between 16-70 years with evidence of asthma
Who may be able to join
- Aged 16-70 years
- Current smokers - explicitly coded in patient records or captured in patient questionnaires
- Evidence of asthma diagnosis and current therapy: ≥2 prescriptions for asthma at different points in time during the baseline year ± a diagnostic code for asthma
- On-going asthma therapy: ≥2 prescription for ICS during the outcome period (i.e. ≥1 prescription in addition to IPD prescription)
- ≥2 years continuous data (i.e. ≥1 year of baseline plus ≥1 year of outcome data)
Who cannot join
- Patients will be excluded from the analysis if they have:
- Any chronic respiratory disease other than asthma
- Are prescribed:
- Maintenance oral steroid therapy during the baseline year
- Combination ICS/long-acting beta agonist (LABA) therapy during baseline year or at IPD
- Multiple ICS prescriptions at IPD or immediately before .
About this study
Official title: Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone and Chlorofluorocarbon Beclometasone in Smoking Asthma - a Retrospective, Real-life Observational Study in a UK Primary Care Asthma Population
To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care asthma population of current smokers.
- Keywords
- Primary Care, Particle size, beclomethasone dipropionate, Asthma Management, Maintenance Therapy, Metered-Dose Inhaler, Smoking
- Medical subject headings
- Asthma, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| 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 | |
| IPDI FP | Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date | |
| IPDI NEF HFA-BDP | Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date | |
| IPDA EF HFA-BDP | Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date | |
| IPDA FP | Patients increasing inhaled corticosteroid therapy as FP MDI at the index date | |
| IPDA NEF HFA-BDP | Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control proxy incorporating SABA use
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
(iv)Average prescribed daily dose of albuterol or terbutaline of ≤200mg
Measured: 1 year
Asthma Exacerbations (ATS Definition)
Defined as an absence of the the following:
- Asthma related hospital attendance or admission, OR A\&E attendance, OR
- Use of acute 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 proxy excluding SABA usage
Control 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
Treatment Success
Success defined as:
No respiratory-related:
Hospital attendance or admission A\&E attendance, OR Out of hours consultation, OR Out-patient department attendance
No GP consultations for lower respiratory tract infection
No prescriptions for acute courses of oral steroids
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, leukotriene receptor antagonists (LTRAs).
Measured: 1 year
Definite asthma-related hospitalisations
Hospitalisations coded with an asthma read code
Measured: 1 year
ICS Compliance
Based on prescription refills
Measured: 1 year
Incidence of oral thrust
Identified as:
- Topical oral anti-fungal prescriptions, and / or
- Coded for oral candidiasis
Measured: 1 year
SABA Dose
Average daily dose of short-acting beta-agonist over the outcome year
Measured: 1 year
Definite and probable asthma-related hospitalisations
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 7,195 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 Professor Price, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729351
- Sponsor's protocol ID
- R01911
- Status last verified
- Nov 2012
- First submitted
- 9 Nov 2012
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Price 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 20692026Barnes N, Price D, Colice G, Chisholm A, Dorinsky P, Hillyer EV, Burden A, Lee AJ, Martin RJ, Roche N, von Ziegenweidt J, Israel E. Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study. Clin Exp Allergy. 2011 Nov;41(11):1521-32. doi: 10.1111/j.1365-2222.2011.03820.x. Epub 2011 Jul 14.
PubMed 21752116Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999 May;54(5):413-9. doi: 10.1136/thx.54.5.413.
PubMed 10212105Ivanova JI, Birnbaum HG, Hsieh M, Yu AP, Seal B, van der Molen T, Emani S, Rosiello RA, Colice GL. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care. 2008 Dec;14(12):801-9.
PubMed 19067497
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone and Chlorofluorocarbon Beclometasone in Smoking Asthma - a Retrospective, Real-life Observational Study in a UK Primary Care Asthma Population
- ClinicalTrials.gov ID
- NCT01729351
- Acronym / sponsor ID
- R01911
- Keywords
- Primary Care, Particle size, beclomethasone dipropionate, Asthma Management, Maintenance Therapy, Metered-Dose Inhaler, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,195 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Nov 2012 (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.
To evaluate the comparative effectiveness of extrafine hydrofluoroalkane beclometasone (EF HFA-BDP) and other inhaled corticosteroid (ICS) therapy commonly used in the UK, specifically fluticasone (FP) and non-extrafine (NEF) BDP (CFC-BDP and NEF HFA-BDP) in a UK primary care asthma population of current smokers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IPDI EF HFA-BDP | – | –Patients initiating inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date |
| IPDI FP | – | –Patients initiating inhaled corticosteroid therapy as FP via pMDI at the index date |
| IPDI NEF HFA-BDP | – | –Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date |
| IPDA EF HFA-BDP | – | –Patients increasing inhaled corticosteroid therapy as extra-fine HFA-BDP MDI at the index date |
| IPDA FP | – | –Patients increasing inhaled corticosteroid therapy as FP MDI at the index date |
| IPDA NEF HFA-BDP | – | –Patients initiating inhaled corticosteroid therapy as non-extra-fine HFA-BDP via pMDI at the index date |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are all current smokers ages between 16-70 years with evidence of asthma
Key inclusion criteria (5 listed)
- Aged 16-70 years
- Current smokers - explicitly coded in patient records or captured in patient questionnaires
- Evidence of asthma diagnosis and current therapy: ≥2 prescriptions for asthma at different points in time during the baseline year ± a diagnostic code for asthma
- On-going asthma therapy: ≥2 prescription for ICS during the outcome period (i.e. ≥1 prescription in addition to IPD prescription)
- ≥2 years continuous data (i.e. ≥1 year of baseline plus ≥1 year of outcome data)
Key exclusion criteria (6 listed)
- Any chronic respiratory disease other than asthma
- Are prescribed:
- Maintenance oral steroid therapy during the baseline year
- Combination ICS/long-acting beta agonist (LABA) therapy during baseline year or at IPD
- Multiple ICS prescriptions at IPD or immediately before .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma Control proxy incorporating SABA use
Time frame: 1 year
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 (iv)Average prescribed daily dose of albuterol or terbutaline of ≤200mg
Asthma Exacerbations (ATS Definition)
Time frame: 1 year
Defined as an absence of the the following: 1. Asthma related hospital attendance or admission, OR A\&E attendance, OR 2. Use of acute oral steroids.
8 secondary outcomes
Exacerbation definition based on clinical experience
Time frame: 1 year
Asthma control proxy excluding SABA usage
Time frame: 1 year
Treatment Success
Time frame: 1 year
Definite asthma-related hospitalisations
Time frame: 1 year
ICS Compliance
Time frame: 1 year
Incidence of oral thrust
Time frame: 1 year
SABA Dose
Time frame: 1 year
Definite and probable asthma-related hospitalisations
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 20 Nov 2012.
- Background: 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.
- Background: PubMed 21752116Barnes N, Price D, Colice G, Chisholm A, Dorinsky P, Hillyer EV, Burden A, Lee AJ, Martin RJ, Roche N, von Ziegenweidt J, Israel E. Asthma control with extrafine-particle hydrofluoroalkane-beclometasone vs. large-particle chlorofluorocarbon-beclometasone: a real-world observational study. Clin Exp Allergy. 2011 Nov;41(11):1521-32. doi: 10.1111/j.1365-2222.2011.03820.x. Epub 2011 Jul 14.
- Background: PubMed 10212105Hansell A, Hollowell J, Nichols T, McNiece R, Strachan D. Use of the General Practice Research Database (GPRD) for respiratory epidemiology: a comparison with the 4th Morbidity Survey in General Practice (MSGP4). Thorax. 1999 May;54(5):413-9. doi: 10.1136/thx.54.5.413.
- Background: PubMed 19067497Ivanova JI, Birnbaum HG, Hsieh M, Yu AP, Seal B, van der Molen T, Emani S, Rosiello RA, Colice GL. Adherence to inhaled corticosteroid use and local adverse events in persistent asthma. Am J Manag Care. 2008 Dec;14(12):801-9.
- Clinical Practice Research DatabaseLink 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 Professor Price principal investigator
University of Aberdeen
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Smoking, 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 5 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 20 Nov 2012. 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?
Asthma Control proxy incorporating SABA use (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 NCT01729351, which also lists 4 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 20 Nov 2012.