AsthmaQvarAsthmaNCT01141439
Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management
An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial summary
The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a… Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Asthma
- What is being tested?
- Extra-fine hydrofluoroalkane-beclomethasone dipropionate, Fluticasone propionate and Beclomethasone dipropionate
- How many people
- 815,377 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2001to Jul 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Primary care asthma patients receiving who either initiated ICS therapy as any of extrafine HFA-BDP, CFC-BDP of FP via MDI at an index prescription date (IPD), or were on existing ICs therapy (any) and had an increase in ICS dose at IPD as any of extrafine HFA-BDP, CFC-BDP of FP via MDI
Who may be able to join
- Included patients must:
- aged 5-60 years
- evidence of asthma: a diagnostic code of asthma or ≥2 prescriptions for asthma in baseline year at different points in time including one of ICS
- on current therapy at the IPD, defined as ≥1 ICS script and ≥1 other asthma prescriptions in the 12 months prior to first change in therapy
- had definite dosing instructions
- have at least 1 year of up-to-standard (UTS) baseline data before IPD
- have at least 1 year of UTS outcome data after 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
- For the therapy increase patient cohort, any patients receiving a combination inhaler in addition to their separate ICS inhaler in the year prior to IPD were also excluded.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
General Practice Research Database
London, London, SW8 5NQ
About this study
Official title: A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population
The objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and paediatrics (5-11yrs).
Read the detailed description
While current UK asthma guidelines are underpinned with evidence from RCTs, much of this evidence has been undertaken in patients who are not representative of the majority of the current UK asthma population. In fact it has been estimated that fewer than 10% of the patients seen in everyday clinical practice would be eligible for inclusion in such trials. 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 and observational studies to inform existing guidelines and help optimise asthma outcomes. A more holistic approach to respiratory research would see RCT evidence complimented by "real-life" data from pragmatic trials and observational studies.
A number of trends are emerged in asthma prescribing that warrant further investigation to ascertain their benefit to both the patient and the NHS. In particular, significant pressure exists to use the cheapest inhaler devices and formulations. An analysis of a pragmatic trial of Qvar versus standard CFC-BDP undertaken by Research in Real Life suggested that Qvar may be offer greater effectiveness in.5,6 In light of these data, the following report details the findings of a study designed to examine the effectiveness of Qvar in real-life clinical practice using the General Practice Research Database (GPRD).
- Conditions
- Asthma
- Being tested
- Extra-fine hydrofluoroalkane-beclomethasone dipropionate, Fluticasone propionate, Beclomethasone dipropionate, Chlorofluorocarbon beclomethasone dipropionate
- Keywords
- Primary care, Asthma management, Inhaled corticosteroids, Beclomethasone dipropionate, Fluticasone propionate, Metred dose inhaler, Extra-fine hydrofluoroalkane, Chlorofluorocarbon
- 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-beclomethasone dipropionateDrug
Also called Qvar®
Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
Extra-fine hydrofluoroalkane-beclomethasone dipropionateDrug
Also called Qvar
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
Fluticasone propionateDrug
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
Beclomethasone dipropionateDrug
An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
fluticasone propionateDrug
Initiation of FP (any dose) via MDI in steroid naive patient
Chlorofluorocarbon beclomethasone dipropionateDrug
Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
| Study group | Role | What they receive |
|---|---|---|
| IPDI HFA-BDP MDI | Patients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI Receives: Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate | |
| IPDI FP MDI | Patients who commenced inhaled corticosteroid therapy as FP via MDI Receives: Drug: fluticasone propionate | |
| IPDA FP MDI | Patients who had a step up in inhaled corticosteroid therapy as FP via MDI Receives: Drug: Fluticasone propionate | |
| IPDA HFA-BDP MDI | Patients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI Receives: Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionate | |
| IPDI CFC-BDP MDI | Patients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI Receives: Drug: Chlorofluorocarbon beclomethasone dipropionate | |
| IPDA CFC-BDP MDI | Patients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI Receives: Drug: Beclomethasone dipropionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proxy asthma control
Primary composite measure asthma control defined as:
- 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 (6)
Revised asthma control
A revised definition of proxy asthma control for sensitivity analysis was defined as:
- No recorded hospital attendance for asthma including admission, A\&E attendance, out of hours attendance or 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
- Average daily prescribed dose of salbutamol of no more than 200mcg and terbutaline 500mcg.
Measured: One-year outcome period
Disaggregated components of the primary control outcome
- Hospital admissions for asthma
- Consultations and hospital attendances for LRTI requiring antibiotics
- Prescriptions for oral steroids
- SABA use
Measured: One-year outcome period
Time to the first asthma exacerbation
Where an exacerbation is defined as:
- An occurrence of unscheduled hospital admission/A\&E attendances for asthma AND/OR
- Use of oral steroids.
Measured: One-year outcome period
Success of the therapeutic regimen
Defined as:
- Exacerbation AND/OR
- Increase in dose of ICS AND/OR
- Change in ICS drug type AND/OR
- Change in delivery device AND/OR
- Use of additional therapy as defined by: LABAs, oral steroids, theophylline, leukotriene receptor antagonists (LTRAs)
Measured: One-year outcome period
Use of anti-fungals
defined as incidences of definite oral candidiasis
Measured: One-year
Daily dose of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP Daily dose* of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP.
BDP-equivalent dose were calculated by multiplying the Qvar and FP doses by a factor of 2. The dose at week 52 was compared with that at week 0 in order to identify the proportion of original (week 0) ICS dose.
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 posted10 Jun 2010 (estimated)
- Study startJan 2001
- Primary completionJun 2007
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- 815,377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Investigators
- David Price, Prof. MD, Principal investigator, Company DirectorAlison Chisholm, MSc, Study director, Research Project Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141439
- Sponsor's protocol ID
- BA4
- Acronym
- QvarAsthma
- Status last verified
- Mar 2013
- First submitted
- 9 Jun 2010
- Last updated
- 14 Mar 2013
- 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 17113277Thomas M, Cleland J, Price D. Database studies in asthma pharmacoeconomics: uses, limitations and quality markers. Expert Opin Pharmacother. 2003 Mar;4(3):351-8. doi: 10.1517/14656566.4.3.351.
PubMed 12614187Tannen RL, Weiner MG, Xie D. Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings. BMJ. 2009 Jan 27;338:b81. doi: 10.1136/bmj.b81.
PubMed 19174434Juniper EF, Price DB, Stampone PA, Creemers JP, Mol SJ, Fireman P. Clinically important improvements in asthma-specific quality of life, but no difference in conventional clinical indexes in patients changed from conventional beclomethasone dipropionate to approximately half the dose of extrafine beclomethasone dipropionate. Chest. 2002 Jun;121(6):1824-32. doi: 10.1378/chest.121.6.1824.
PubMed 12065345Price D, Haughney J, Duerden M, Nicholls C, Moseley C. The cost effectiveness of chlorofluorocarbon-free beclomethasone dipropionate in the treatment of chronic asthma: a cost model based on a 1-year pragmatic, randomised clinical study. Pharmacoeconomics. 2002;20(10):653-64. doi: 10.2165/00019053-200220100-00002.
PubMed 12162754Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
PubMed 3558716Cliniclue [homepage on the internet]. The Clinical Information Consultancy CLINICLUE® [updated 2008; cited 15 May 2009]. Available online at: http://www.cliniclue.com
SPSS [homepage on the internet]. Chicago: SPSS Inc [updated 2009; cited 15 May 2009]. Available online at: http://www.spss.com/UK/
Microsoft office online [homepage on the internet]. USA: Microsoft Corporation [updated 2009; cited 15 May 2009]. Available online at: http://office.microsoft.com/excel
STATA: Data Analysis and Statistical Software [homepage on the internet]. Texas: STATA [updated 2009; cited 15 May 2009]. Available online at: http://www.stata.com/
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population
- ClinicalTrials.gov ID
- NCT01141439
- Acronym / sponsor ID
- QvarAsthma / BA4
- Conditions
- Asthma
- Keywords
- Primary care, Asthma management, Inhaled corticosteroids, Beclomethasone dipropionate, Fluticasone propionate, Metred dose inhaler, Extra-fine hydrofluoroalkane, Chlorofluorocarbon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815,377 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.
- Study start
- Jan 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Jun 2010 (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 objective of the study was to compare the effectiveness, cost-effectiveness and direct healthcare costs of managing asthma in patients with evidence of persistent asthma, following the initiation and increased dose of inhaled corticosteroid (ICS) therapy using HFA-BDP (Qvar®) (either as initial therapy or as a step-up therapy) compared with the most commonly prescribed alternative ICS in the UK, CFC-beclometasone (BDP) and fluticasone (FP) as metered dose inhalers (MDIs). Qvar vs FP analyses were split between adults (12-60yrs) and paediatrics (5-11yrs).
Detailed description
While current UK asthma guidelines are underpinned with evidence from RCTs, much of this evidence has been undertaken in patients who are not representative of the majority of the current UK asthma population. In fact it has been estimated that fewer than 10% of the patients seen in everyday clinical practice would be eligible for inclusion in such trials. 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 and observational studies to inform existing guidelines and help optimise asthma outcomes. A more holistic approach to respiratory research would see RCT evidence complimented by "real-life" data from pragmatic trials and observational studies.
A number of trends are emerged in asthma prescribing that warrant further investigation to ascertain their benefit to both the patient and the NHS. In particular, significant pressure exists to use the cheapest inhaler devices and formulations. An analysis of a pragmatic trial of Qvar versus standard CFC-BDP undertaken by Research in Real Life suggested that Qvar may be offer greater effectiveness in.5,6 In light of these data, the following report details the findings of a study designed to examine the effectiveness of Qvar in real-life clinical practice using the General Practice Research Database (GPRD).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IPDI HFA-BDP MDI | – | Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionatePatients who commenced inhaled corticosteroid therapy as HFA-BDP via MDI |
| IPDI FP MDI | – | Drug: fluticasone propionatePatients who commenced inhaled corticosteroid therapy as FP via MDI |
| IPDA FP MDI | – | Drug: Fluticasone propionatePatients who had a step up in inhaled corticosteroid therapy as FP via MDI |
| IPDA HFA-BDP MDI | – | Drug: Extra-fine hydrofluoroalkane-beclomethasone dipropionatePatients who had a step up in inhaled corticosteroid therapy as HFA-BDP via MDI |
| IPDI CFC-BDP MDI | – | Drug: Chlorofluorocarbon beclomethasone dipropionatePatients who commenced inhaled corticosteroid therapy as CFC-BDP via MDI |
| IPDA CFC-BDP MDI | – | Drug: Beclomethasone dipropionatePatients who had a step up in inhaled corticosteroid therapy as CFC-BDP via MDI |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary care asthma patients receiving who either initiated ICS therapy as any of extrafine HFA-BDP, CFC-BDP of FP via MDI at an index prescription date (IPD), or were on existing ICs therapy (any) and had an increase in ICS dose at IPD as any of extrafine HFA-BDP, CFC-BDP of FP via MDI
Key inclusion criteria (7 listed)
- aged 5-60 years
- evidence of asthma: a diagnostic code of asthma or ≥2 prescriptions for asthma in baseline year at different points in time including one of ICS
- on current therapy at the IPD, defined as ≥1 ICS script and ≥1 other asthma prescriptions in the 12 months prior to first change in therapy
- had definite dosing instructions
- have at least 1 year of up-to-standard (UTS) baseline data before IPD
Key exclusion criteria (3 listed)
- 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
- For the therapy increase patient cohort, any patients receiving a combination inhaler in addition to their separate ICS inhaler in the year prior to IPD were also excluded.
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-beclomethasone dipropionateAlso: Qvar®Initiation of HFA-BDP (any dose) in steroid naive patients via MDI | Drug | IPDI HFA-BDP MDI |
| Extra-fine hydrofluoroalkane-beclomethasone dipropionateAlso: QvarAn increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI | Drug | IPDA HFA-BDP MDI |
| Fluticasone propionateAn increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI | Drug | IPDA FP MDI |
| Beclomethasone dipropionateAn increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI | Drug | IPDA CFC-BDP MDI |
| fluticasone propionateInitiation of FP (any dose) via MDI in steroid naive patient | Drug | IPDI FP MDI |
| Chlorofluorocarbon beclomethasone dipropionateInitiation of CFC-BDP (any dose) via MDI in steroid naive patient | Drug | IPDI CFC-BDP MDI |
Primary outcome
Proxy asthma control
Time frame: One-year outcome period
Primary composite measure asthma control defined as: * 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.
6 secondary outcomes
Revised asthma control
Time frame: One-year outcome period
Disaggregated components of the primary control outcome
Time frame: One-year outcome period
Time to the first asthma exacerbation
Time frame: One-year outcome period
Success of the therapeutic regimen
Time frame: One-year outcome period
Use of anti-fungals
Time frame: One-year
Daily dose of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP Daily dose* of ICS (BDP equivalent) at week 52 compared with week 0 and proportion on original dose of BDP.
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 Mar 2013.
- 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 12614187Thomas M, Cleland J, Price D. Database studies in asthma pharmacoeconomics: uses, limitations and quality markers. Expert Opin Pharmacother. 2003 Mar;4(3):351-8. doi: 10.1517/14656566.4.3.351.
- Background: PubMed 19174434Tannen RL, Weiner MG, Xie D. Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings. BMJ. 2009 Jan 27;338:b81. doi: 10.1136/bmj.b81.
- Background: PubMed 12065345Juniper EF, Price DB, Stampone PA, Creemers JP, Mol SJ, Fireman P. Clinically important improvements in asthma-specific quality of life, but no difference in conventional clinical indexes in patients changed from conventional beclomethasone dipropionate to approximately half the dose of extrafine beclomethasone dipropionate. Chest. 2002 Jun;121(6):1824-32. doi: 10.1378/chest.121.6.1824.
- Background: PubMed 12162754Price D, Haughney J, Duerden M, Nicholls C, Moseley C. The cost effectiveness of chlorofluorocarbon-free beclomethasone dipropionate in the treatment of chronic asthma: a cost model based on a 1-year pragmatic, randomised clinical study. Pharmacoeconomics. 2002;20(10):653-64. doi: 10.2165/00019053-200220100-00002.
- Background: PubMed 3558716Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
- BackgroundCliniclue [homepage on the internet]. The Clinical Information Consultancy CLINICLUE® [updated 2008; cited 15 May 2009]. Available online at: http://www.cliniclue.com
- BackgroundSPSS [homepage on the internet]. Chicago: SPSS Inc [updated 2009; cited 15 May 2009]. Available online at: http://www.spss.com/UK/
- BackgroundMicrosoft office online [homepage on the internet]. USA: Microsoft Corporation [updated 2009; cited 15 May 2009]. Available online at: http://office.microsoft.com/excel
- BackgroundSTATA: Data Analysis and Statistical Software [homepage on the internet]. Texas: STATA [updated 2009; cited 15 May 2009]. Available online at: http://www.stata.com/
- Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)Link provided by the sponsor.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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, Prof. MD principal investigator
Company Director
Alison Chisholm, MSc study director
Research Project 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 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 14 Mar 2013. 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 NCT01141439, which also lists 11 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 Mar 2013.