AsthmaNCT01141465
Real-world Effectiveness of Combination Therapy in Asthma
An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial summary
This study will evaluate and compare the effectiveness of asthma management in patients with evidence of persistent asthma following a switch in asthma therapy to combination inhaled glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either: fixed-combination fluticasone propionate / salmeterol… Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone / formoterol metered dose inhaler, Fluticasone / salmeterol dry powder inhaler and Budesonide / formoterol dry powder inhaler
- How many people
- 815,377 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2001to Feb 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: Primary care asthma patients receiving ICS therapy (any of BDP, extrafine HFA-BDP, BUD or FP as pMDI, BAI or DPI) plus as needed SABA reliever therapy who underwent a change in asthma therapy to combination ICS/LABA therapy as FP/SAL (MDI or DPI) or BUD/FOR (DPI) at the same or at least twice the BDP-equivalent dose of ICS prescribed during baseline.
Who may be able to join
- Aged: 4-80 years: Paediatric cohort (aged 4-11 years); Adult cohort (aged 12-69 years); Elderly cohort (aged 70-80 years.
- Evidence of asthma: i.e. a diagnostic code of asthma or ≥2 prescriptions for asthma at different points in time during the prior year, including one ICS prescription.
- Be on current asthma therapy: i.e. ≥1 asthma prescriptions in the prior year, and at least 1 other asthma prescription during the same period.
- 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
- Diagnostic read code for chronic respiratory disease (including COPD) at any time
- On maintenance oral steroid therapy at baseline
- Any patients receiving a combination inhaler in addition to their separate ICS inhaler in the baseline year.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
General Practice Research Database
London, SW8 5NQ
About this study
Official title: A Retrospective Evaluation of the Effectiveness of Fixed-dose Combination Inhaled Corticosteroid /. Long-acting Beta Agonist (ICS/LABA) Therapy in the Management of Asthma in a Representative UK Primary Care Population
This study will evaluate and compare the effectiveness of asthma management in patients with evidence of persistent asthma following a switch in asthma therapy to combination inhaled glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either: fixed-combination fluticasone propionate / salmeterol (FP/SAL; Seretide®) via pressurised metered-dose inhaler (pMDI) or dry-powder inhaler (DPI) plus as-needed (prn) reliever therapy (salbutamol as DPI, BAI or pMDI), or fixed-combination budesonide / formoterol (BUD/FOR; Symbicort®) via DPI plus prn reliever therapy (salbutamol as DPI, BAI or pMDI or bricanyl as DPI). The final analysis plan will define exact comparators and age groups to be studied after reviewing baseline data.
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.
The fixed combination asthma inhalers FP/SAL (as pMDI and DPI) and BUD/FOR (as DPI) are indicated for use in asthma when adequate asthma control is not achieved with low / medium dose ICS therapy and prn reliever therapy (a short-acting beta-agonist [SABA]). Fixed combination inhalers are also indicated in patients already adequately controlled on separate ICS/LABA therapy. However, emerging trends in asthma prescribing indicate increasing use of add-on therapies (particularly in the form of combination inhalers) in the early stages of asthma therapy, even as first-line therapy.
The British Thoracic Society (BTS) Scottish Intercollegiate Guidelines Network (SIGN) guidelines on the management of asthma advise that there is no difference in efficacy between ICS/LABA therapy given as separate or combined inhalers. However, they do note that, once a patients is on stable therapy, combination inhalers have the advantage of guaranteeing that patients do not take their LABA without their ICS.
In practice, there is significant pressure (supported by asthma guidelines) to use the least expensive, effective inhaled therapies available. While the effect of increased use of combination therapies in terms of patient benefits remains uncertain, the impact on treatment costs for the United Kingdom's (UK's) National Health Service (NHS) is unequivocal and, to date, there are limited data available as to the absolute and relative effectiveness of the ICS/LABA combination therapies currently licensed.
There are a number of inhaler delivery devices available for use in asthma management. Whatever therapy is prescribed, optimal treatment response requires effective drug delivery within the airways; selecting the most appropriate delivery device for an asthma patient, therefore, plays an important role in optimising their asthma control. According to the recent BTS/SIGN guidelines, there is currently no evidence of a clinical difference in the effectiveness of therapy delivery via pMDI ± spacer compared with DPI in either adults or children, and more recent DPIs are rated as effective as older DPIs. Effective use of DPIs and pMDI requires entirely different inhalation techniques and there is some debate as to whether patients prescribed different device types for their reliever and preventer medication (requiring different techniques for each) may have poorer disease control than those prescribed the same device type for both preventer and reliever. Combining aerosols (e.g. pMDI preventer plus BAI reliever) is not considered to cause a problem in this respect.
The aim of this study is to compare the absolute and relative effectiveness of currently licensed ICS/LABA combinations - FP/SAL and BUD/FOR (and their available delivery devices) - in children and adults with asthma whose therapy was changed or increased. Consideration will also be given to the effect of reliever therapy inhaler and the effect of consistency of device used (i.e. same or different devices for preventer and inhaler therapies) on asthma control outcomes. Also to be evaluated are the associated impact of inhaler technique review, recorded inhaler handling problems and use of a spacer in conjunction with a pMDI in terms of achieving asthma control outcomes.
- Conditions
- Asthma
- Being tested
- Fluticasone / formoterol metered dose inhaler, Fluticasone / salmeterol dry powder inhaler, Budesonide / formoterol dry powder inhaler, Fluticasone / salmeterol metred dose inhaler, BUD/FOR dry powder inhaler
- Keywords
- Primary care, Asthma management, Combined therapy, Real-world, Effectiveness, Control, Exacerbations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone / formoterol metered dose inhalerDrug
Also called Seretide MDI
Prescribed at the same BDP-equivalent dose as baseline ICS
Fluticasone / salmeterol dry powder inhalerDrug
Also called Seretide DPI
Prescribed at the same BDP-equivalent dose as baseline ICS
Budesonide / formoterol dry powder inhalerDrug
Also called Symbicort DPI
Prescribed at the same BDP-equivalent dose as baseline ICS
Fluticasone / salmeterol dry powder inhalerDrug
Also called Seretide DPI
Prescribed at ≥twice BDP-equivalent dose as baseline ICS
Fluticasone / salmeterol metred dose inhalerDrug
Also called Seretide MDI
Prescribed at ≥twice BDP-equivalent dose as baseline ICS
BUD/FOR dry powder inhalerDrug
Also called Symbicort DPI
Prescribed at ≥twice BDP-equivalent dose as baseline ICS
| Study group | Role | What they receive |
|---|---|---|
| IPDA FP/SAL DPI | Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL DPI at ≥twice the equivalent BDP-equivalent dose Receives: Drug: Fluticasone / salmeterol dry powder inhaler | |
| IPDA FP/SAL MDI | Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL MDI at ≥twice the equivalent BDP-equivalent dose Receives: Drug: Fluticasone / salmeterol metred dose inhaler | |
| IPDI FP/SAL DPI | Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL DPI at equivalent BDP-equivalent dose Receives: Drug: Fluticasone / salmeterol dry powder inhaler | |
| IPDI BUD/FOR DPI | Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as BUD/FOR DPI at equivalent BDP-equivalent dose Receives: Drug: Budesonide / formoterol dry powder inhaler | |
| IPDI FP/SAL MDI | Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL MDI at equivalent BDP-equivalent dose Receives: Drug: Fluticasone / formoterol metered dose inhaler | |
| IPDA BUD/FOR DPI | Patients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as BUD/FOR DPI at ≥twice the equivalent BDP-equivalent dose Receives: Drug: BUD/FOR dry powder inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite proxy for asthma control
- 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 steroids, AND
- No GP consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
Measured: One-year outcome period
Exacerbations (total and rate ratio)
- Unscheduled hospital admissions / A\&E attendance for asthma, AND/OR
- Use of oral steroids.
Measured: One-year outcome period
GOAL Total Control (proxy measure to replicate total control as measured in the GOAL RCT in a real world patient population
- No day-time symptoms;
- No night-time symptoms;
- No exacerbations;
- No treatment-related adverse events
- PEF ≥80% predicted = "normal"
- No SABA use
Measured: 6 months (sensitivity analysis at 8 weeks)
GOAL exacerbations
Absence of:
- Documented episodes of hospitalisations AND/OR
- Exacerbation treatment - oral steroids or antibiotics for asthma over one year
Measured: One year
Secondary outcomes (4)
Compliance with ICS/LABA combination therapy
Percentage compliance calculated based on prescription refills
Measured: One year outcome period
Compliance with ICS as part of ICS/LABA combination therapy
Percentage compliance calculated based on prescription refill
Measured: One-year outcome period
Treatment success
Success of the therapeutic regimen, defined as the absence of:
- Exacerbation, and
- Increased dose of ICS, and
- Change in ICS/LABA, and
- Change in delivery device, and
- Use of additional therapy as defined by: oral steroids, theophylline, leukotreine receptor antagonists (LTRAs).
Measured: One-year outcome period
SABA dosage
Categorised average SABA dosage during outcome year: 0mcg, >0-100mcg, >100-200mcg, >200-400mcg, >400-800mcg, >800mcg.
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 completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Mundipharma Research Limited
- Investigators
- David Price, Prof. MD, Principal investigator, Company DirectorAlison Chisholm, MSc, Study director, Research Project Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141465
- Sponsor's protocol ID
- BS30
- Status last verified
- Jun 2010
- First submitted
- 9 Jun 2010
- Last updated
- 10 Jun 2010
- 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 16275363Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.
PubMed 15256389British Thoracic Society (BTS) Scottish Intercollegiate Guidelines Network (SIGN) 101. British Guideline on the Management of Asthma: a national clinical guideline. 2008. Available online at: www.sign.ac.uk/guidelines/fulltext/101/index.html
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Evaluation of the Effectiveness of Fixed-dose Combination Inhaled Corticosteroid /. Long-acting Beta Agonist (ICS/LABA) Therapy in the Management of Asthma in a Representative UK Primary Care Population
- ClinicalTrials.gov ID
- NCT01141465
- Acronym / sponsor ID
- BS30
- Conditions
- Asthma
- Keywords
- Primary care, Asthma management, Combined therapy, Real-world, Effectiveness, Control, Exacerbations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815,377 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Mundipharma Research Limited
- Study start
- Jan 2001
- Primary completion
- Jun 2007 (actual)
- Study completion
- Feb 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.
This study will evaluate and compare the effectiveness of asthma management in patients with evidence of persistent asthma following a switch in asthma therapy to combination inhaled glucocorticosteroid (ICS) / long-acting bronchodilator (LABA) therapy as either: fixed-combination fluticasone propionate / salmeterol (FP/SAL; Seretide®) via pressurised metered-dose inhaler (pMDI) or dry-powder inhaler (DPI) plus as-needed (prn) reliever therapy (salbutamol as DPI, BAI or pMDI), or fixed-combination budesonide / formoterol (BUD/FOR; Symbicort®) via DPI plus prn reliever therapy (salbutamol as DPI, BAI or pMDI or bricanyl as DPI). The final analysis plan will define exact comparators and age groups to be studied after reviewing baseline data.
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.
The fixed combination asthma inhalers FP/SAL (as pMDI and DPI) and BUD/FOR (as DPI) are indicated for use in asthma when adequate asthma control is not achieved with low / medium dose ICS therapy and prn reliever therapy (a short-acting beta-agonist [SABA]). Fixed combination inhalers are also indicated in patients already adequately controlled on separate ICS/LABA therapy. However, emerging trends in asthma prescribing indicate increasing use of add-on therapies (particularly in the form of combination inhalers) in the early stages of asthma therapy, even as first-line therapy.
The British Thoracic Society (BTS) Scottish Intercollegiate Guidelines Network (SIGN) guidelines on the management of asthma advise that there is no difference in efficacy between ICS/LABA therapy given as separate or combined inhalers. However, they do note that, once a patients is on stable therapy, combination inhalers have the advantage of guaranteeing that patients do not take their LABA without their ICS.
In practice, there is significant pressure (supported by asthma guidelines) to use the least expensive, effective inhaled therapies available. While the effect of increased use of combination therapies in terms of patient benefits remains uncertain, the impact on treatment costs for the United Kingdom's (UK's) National Health Service (NHS) is unequivocal and, to date, there are limited data available as to the absolute and relative effectiveness of the ICS/LABA combination therapies currently licensed.
There are a number of inhaler delivery devices available for use in asthma management. Whatever therapy is prescribed, optimal treatment response requires effective drug delivery within the airways; selecting the most appropriate delivery device for an asthma patient, therefore, plays an important role in optimising their asthma control. According to the recent BTS/SIGN guidelines, there is currently no evidence of a clinical difference in the effectiveness of therapy delivery via pMDI ± spacer compared with DPI in either adults or children, and more recent DPIs are rated as effective as older DPIs. Effective use of DPIs and pMDI requires entirely different inhalation techniques and there is some debate as to whether patients prescribed different device types for their reliever and preventer medication (requiring different techniques for each) may have poorer disease control than those prescribed the same device type for both preventer and reliever. Combining aerosols (e.g. pMDI preventer plus BAI reliever) is not considered to cause a problem in this respect.
The aim of this study is to compare the absolute and relative effectiveness of currently licensed ICS/LABA combinations - FP/SAL and BUD/FOR (and their available delivery devices) - in children and adults with asthma whose therapy was changed or increased. Consideration will also be given to the effect of reliever therapy inhaler and the effect of consistency of device used (i.e. same or different devices for preventer and inhaler therapies) on asthma control outcomes. Also to be evaluated are the associated impact of inhaler technique review, recorded inhaler handling problems and use of a spacer in conjunction with a pMDI in terms of achieving asthma control outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| IPDA FP/SAL DPI | – | Drug: Fluticasone / salmeterol dry powder inhalerPatients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL DPI at ≥twice the equivalent BDP-equivalent dose |
| IPDA FP/SAL MDI | – | Drug: Fluticasone / salmeterol metred dose inhalerPatients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL MDI at ≥twice the equivalent BDP-equivalent dose |
| IPDI FP/SAL DPI | – | Drug: Fluticasone / salmeterol dry powder inhalerPatients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL DPI at equivalent BDP-equivalent dose |
| IPDI BUD/FOR DPI | – | Drug: Budesonide / formoterol dry powder inhalerPatients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as BUD/FOR DPI at equivalent BDP-equivalent dose |
| IPDI FP/SAL MDI | – | Drug: Fluticasone / formoterol metered dose inhalerPatients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as FP/SAL MDI at equivalent BDP-equivalent dose |
| IPDA BUD/FOR DPI | – | Drug: BUD/FOR dry powder inhalerPatients who were on inhaled corticosteroid therapy during the baseline year (any ICS therapy) who, at an index prescription date, initiated combination therapy as BUD/FOR DPI at ≥twice the equivalent BDP-equivalent dose |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care asthma patients receiving ICS therapy (any of BDP, extrafine HFA-BDP, BUD or FP as pMDI, BAI or DPI) plus as needed SABA reliever therapy who underwent a change in asthma therapy to combination ICS/LABA therapy as FP/SAL (MDI or DPI) or BUD/FOR (DPI) at the same or at least twice the BDP-equivalent dose of ICS prescribed during baseline.
Key inclusion criteria (4 listed)
- Aged: 4-80 years: Paediatric cohort (aged 4-11 years); Adult cohort (aged 12-69 years); Elderly cohort (aged 70-80 years.
- Evidence of asthma: i.e. a diagnostic code of asthma or ≥2 prescriptions for asthma at different points in time during the prior year, including one ICS prescription.
- Be on current asthma therapy: i.e. ≥1 asthma prescriptions in the prior year, and at least 1 other asthma prescription during the same period.
- 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).
Key exclusion criteria (3 listed)
- Diagnostic read code for chronic respiratory disease (including COPD) at any time
- On maintenance oral steroid therapy at baseline
- Any patients receiving a combination inhaler in addition to their separate ICS inhaler in the 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 |
|---|---|---|
| Fluticasone / formoterol metered dose inhalerAlso: Seretide MDIPrescribed at the same BDP-equivalent dose as baseline ICS | Drug | IPDI FP/SAL MDI |
| Fluticasone / salmeterol dry powder inhalerAlso: Seretide DPIPrescribed at the same BDP-equivalent dose as baseline ICS | Drug | IPDI FP/SAL DPI |
| Budesonide / formoterol dry powder inhalerAlso: Symbicort DPIPrescribed at the same BDP-equivalent dose as baseline ICS | Drug | IPDI BUD/FOR DPI |
| Fluticasone / salmeterol dry powder inhalerAlso: Seretide DPIPrescribed at ≥twice BDP-equivalent dose as baseline ICS | Drug | IPDA FP/SAL DPI |
| Fluticasone / salmeterol metred dose inhalerAlso: Seretide MDIPrescribed at ≥twice BDP-equivalent dose as baseline ICS | Drug | IPDA FP/SAL MDI |
| BUD/FOR dry powder inhalerAlso: Symbicort DPIPrescribed at ≥twice BDP-equivalent dose as baseline ICS | Drug | IPDA BUD/FOR DPI |
Primary outcome
Composite proxy for asthma control
Time frame: One-year outcome period
* 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 steroids, AND * No GP consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
Exacerbations (total and rate ratio)
Time frame: One-year outcome period
* Unscheduled hospital admissions / A\&E attendance for asthma, AND/OR * Use of oral steroids.
GOAL Total Control (proxy measure to replicate total control as measured in the GOAL RCT in a real world patient population
Time frame: 6 months (sensitivity analysis at 8 weeks)
* No day-time symptoms; * No night-time symptoms; * No exacerbations; * No treatment-related adverse events * PEF ≥80% predicted = "normal" * No SABA use
GOAL exacerbations
Time frame: One year
Absence of: * Documented episodes of hospitalisations AND/OR * Exacerbation treatment - oral steroids or antibiotics for asthma over one year
4 secondary outcomes
Compliance with ICS/LABA combination therapy
Time frame: One year outcome period
Compliance with ICS as part of ICS/LABA combination therapy
Time frame: One-year outcome period
Treatment success
Time frame: One-year outcome period
SABA dosage
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 10 Jun 2010.
- 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 15256389Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.
- BackgroundBritish Thoracic Society (BTS) Scottish Intercollegiate Guidelines Network (SIGN) 101. British Guideline on the Management of Asthma: a national clinical guideline. 2008. Available online at: www.sign.ac.uk/guidelines/fulltext/101/index.html
- Optimum Patient Care is the Research in Real Life's sister company (a social enterprise organisation)Link 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, 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 4 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 10 Jun 2010. 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?
Composite proxy for asthma control (time frame: One-year outcome period). The study lists 4 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 NCT01141465, which also lists 5 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 10 Jun 2010.