AsthmaEBsalbutamolNCT01313585
Device Mixing in Asthma, a General Practice Research Database Study
An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial summary
This study will compare the absolute and relative effectiveness of asthma management in patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) - beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever medication (short-acting beta2-agonist [SABA]… Read more about this study
- Who is it for?
- Ages 4 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device, Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device and Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device
- How many people
- 815,377 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 1991to Mar 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: Asthma patients on SABA therapy (any available) monotherapy who, at the index date, either: (i) IPDI: initiate ICS therapy as BDP EB at the index date and also receive reliever therapy as either*: * Salbutamol EB, or * Salbutamol MDI, OR, who (ii) IPDA: receive a recorded increase in ICS therapy as BDP EB at the index date and also receive reliever therapy as either*: * Salbutamol EB, or * Salbutamol MDI.
Who may be able to join
- Aged: 4-80 years:
- Paediatric cohort (aged 4-11 years), and
- Adult cohort (aged 12-80 years )
- Evidence of asthma:
- a diagnostic code for asthma, and / or
- ≥2 prescriptions for asthma at different points in time during the prior year and/ or
Show all 11Show fewer
- ≥2 prescriptions for asthma therapies during the outcome year, including ≥1 ICS prescription (in addition to that received at IPD) - IPDI cohort only
- Be on current asthma therapy (for the IPDA cohort only):
- ≥1 ICS prescription in the prior year, and
- ≥1 other asthma prescription during the baseline year.
- Have at least one year of up-to-standard (UTS) baseline data (prior to the IPD) and at least one year of UTS outcome data (following the IPD).
Who cannot join
- had a COPD read code at any time; and/or
- received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or
- received a long-acting beta2-agonsist (LABA) in addition to a separate ICS inhaler in the baseline year
- received ICS therapy during baseline year via DPI (in IPDA cohort only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective, Real-life Observational Evaluation of the Effectiveness of Mixed Maintenance and Reliever Inhaler Types in Patients in the Management of Asthma in a Representative UK Primary Care Population
This study will compare the absolute and relative effectiveness of asthma management in patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) - beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever medication (short-acting beta2-agonist [SABA] therapy) via either a BAI (i.e. Easi-breathe® [EB] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI salbutamol).
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.
Inhalation therapy is the cornerstone of asthma treatment, used for the delivery of 'reliever' bronchodilator therapy (e.g. salbutamol) as well as anti-inflammatory corticosteroid 'maintenance' or 'controller' therapy. Currently available inhaler devices include MDIs, breath-actuated MDIs (BAIs), and dry powder inhalers (DPIs). Both BAIs and DPIs are actuated by the patient's inhalation manoeuvre, while MDIs are actuated by the patient's pressing of a button, which must thus be coordinated with inhalation. The clinical effectiveness of inhalation therapy derives from delivery of drug to the target sites in the lungs, and evidence is mounting that suboptimal use of inhaler devices is a common problem contributing to compromised asthma control for many patients. Indeed, decreased asthma control has been linked to the number of mistakes when using MDIs for delivering inhaled corticosteroids (ICS).
There is also evidence that the ability of patients to use the different inhaler device types is variable. Nonetheless, recent reviews of RCTs, while recognising the importance of inhaler technique, have concluded that inhaler devices do not differ significantly in efficacy and that the cheapest inhaler device should be used. However, as results are based on RCTs they should be applied with care in light of the aforementioned issues around external validity of RCTs and the ability to extrapolate their findings across a broad patient population. Moreover, patients enrolled in RCTs typically receive extensive training and must demonstrate and maintain proper inhaler technique, seldom accomplished in a real-world setting.
The aim of this study is to compare the absolute and relative effectiveness of ICS (maintenance) plus SABA (reliever) therapy delivered via same-type devices (namely BDP via EB plus salbutamol via EB [BAI]) and that delivered via different device types (i.e. BDP via EB [BAI] plus SABA via MDI) in a real-life, representative, UK primary care asthma population.
- Conditions
- Asthma
- Being tested
- Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device, Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device, Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device, Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI
- Keywords
- Primary care, asthma management, inhaler device, maintenance therapy, reliever therapy, Easibreathe salbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe deviceDrug
Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI deviceDrug
Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe deviceDrug
Increase of beclometasone via the Easibreathe device plus salbutamol via an MDIDrug
| Study group | Role | What they receive |
|---|---|---|
| IPDA salbutamol MDI | receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI Receives: Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI | |
| IPDA salbutamol EB | receive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe Receives: Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device | |
| IPDI salbutamol EB | initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe Receives: Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device | |
| IPDI salbutamol MDI | initiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI Receives: Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proxy asthma control
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 steroids, AND
- No GP consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
Measured: One-year outcome period
Total number of asthma exacerbations and exacerbation rate ratio
Where exacerbation is defined as an occurrence of:
- Unscheduled hospital admissions / A\&E attendance for asthma, OR
- Use of oral steroids
Measured: One-year outcome period
Secondary outcomes (3)
Treatment success 1
Success: defined as:
(i) Exacerbation:
- Unscheduled hospital admissions / A\&E attendance for asthma, OR
- Acute use of oral steroids
AND
(ii) No consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics
AND
(iii) No change in therapeutic regimen:
- Increased dose of ICS, and/or
- Change in ICS/LABA, and/or
- Change in delivery device, and/or
- Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs).
Measured: One-year outcome period
Treatment success 2 (independent of possible cost savings)
Success: defined as:
(i) Exacerbation:
- Unscheduled hospital admissions / A\&E attendance for asthma, OR
- Acute use of oral steroids
AND
(ii) No consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics
AND
(iii) No change in therapeutic regimen:
- Increased dose of ICS, and/or
- Use of additional therapy as defined by: theophylline, leukotreine receptor antagonists (LTRAs).
Measured: One-year outcome period
Respiratory-related hospitalisations and referrals.
Mean number of respiratory-related hospitalisations and referrals per patient recorded during the one-year outcome period
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 Mar 2011 (estimated)
- Study startJan 1991
- Primary completionJun 2007
- Study completionMar 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
- NCT01313585
- Sponsor's protocol ID
- 003/10
- Acronym
- EBsalbutamol
- Status last verified
- Mar 2011
- First submitted
- 10 Mar 2011
- Last updated
- 14 Mar 2011
- 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 16275363Crompton GK, Barnes PJ, Broeders M, Corrigan C, Corbetta L, Dekhuijzen R, Dubus JC, Magnan A, Massone F, Sanchis J, Viejo JL, Voshaar T; Aerosol Drug Management Improvement Team. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med. 2006 Sep;100(9):1479-94. doi: 10.1016/j.rmed.2006.01.008. Epub 2006 Feb 21.
PubMed 16495040Chrystyn 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 19513494Giraud 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 11866004Lenney J, Innes JA, Crompton GK. Inappropriate inhaler use: assessment of use and patient preference of seven inhalation devices. EDICI. Respir Med. 2000 May;94(5):496-500. doi: 10.1053/rmed.1999.0767.
PubMed 10868714Molimard M, Raherison C, Lignot S, Depont F, Abouelfath A, Moore N. Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003 Fall;16(3):249-54. doi: 10.1089/089426803769017613.
PubMed 14572322Brocklebank D, Ram F, Wright J, Barry P, Cates C, Davies L, Douglas G, Muers M, Smith D, White J. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. Health Technol Assess. 2001;5(26):1-149. doi: 10.3310/hta5260.
PubMed 11701099Brocklebank D, Wright J, Cates C. Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering corticosteroids in asthma. BMJ. 2001 Oct 20;323(7318):896-900. doi: 10.1136/bmj.323.7318.896.
PubMed 11668133Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.
PubMed 15654001
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Real-life Observational Evaluation of the Effectiveness of Mixed Maintenance and Reliever Inhaler Types in Patients in the Management of Asthma in a Representative UK Primary Care Population
- ClinicalTrials.gov ID
- NCT01313585
- Acronym / sponsor ID
- EBsalbutamol / 003/10
- Conditions
- Asthma
- Keywords
- Primary care, asthma management, inhaler device, maintenance therapy, reliever therapy, Easibreathe salbutamol
- 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 1991
- Primary completion
- Jun 2007 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the absolute and relative effectiveness of asthma management in patients on inhaled corticosteroid (ICS) maintenance therapy as Easi-breathe® (EB) - beclometasone dipropionate (BDP) breath-actuated inhaler (BAI) - and as-needed (prn) reliever medication (short-acting beta2-agonist [SABA] therapy) via either a BAI (i.e. Easi-breathe® [EB] salbutamol) or via a pressurised metered dose inhaler (MDI) (e.g. MDI salbutamol).
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.
Inhalation therapy is the cornerstone of asthma treatment, used for the delivery of 'reliever' bronchodilator therapy (e.g. salbutamol) as well as anti-inflammatory corticosteroid 'maintenance' or 'controller' therapy. Currently available inhaler devices include MDIs, breath-actuated MDIs (BAIs), and dry powder inhalers (DPIs). Both BAIs and DPIs are actuated by the patient's inhalation manoeuvre, while MDIs are actuated by the patient's pressing of a button, which must thus be coordinated with inhalation. The clinical effectiveness of inhalation therapy derives from delivery of drug to the target sites in the lungs, and evidence is mounting that suboptimal use of inhaler devices is a common problem contributing to compromised asthma control for many patients. Indeed, decreased asthma control has been linked to the number of mistakes when using MDIs for delivering inhaled corticosteroids (ICS).
There is also evidence that the ability of patients to use the different inhaler device types is variable. Nonetheless, recent reviews of RCTs, while recognising the importance of inhaler technique, have concluded that inhaler devices do not differ significantly in efficacy and that the cheapest inhaler device should be used. However, as results are based on RCTs they should be applied with care in light of the aforementioned issues around external validity of RCTs and the ability to extrapolate their findings across a broad patient population. Moreover, patients enrolled in RCTs typically receive extensive training and must demonstrate and maintain proper inhaler technique, seldom accomplished in a real-world setting.
The aim of this study is to compare the absolute and relative effectiveness of ICS (maintenance) plus SABA (reliever) therapy delivered via same-type devices (namely BDP via EB plus salbutamol via EB [BAI]) and that delivered via different device types (i.e. BDP via EB [BAI] plus SABA via MDI) in a real-life, representative, UK primary care asthma population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPDA salbutamol MDI | – | Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via an MDIreceive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI |
| IPDA salbutamol EB | – | Drug: Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe devicereceive a recorded increase in ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe |
| IPDI salbutamol EB | – | Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe deviceinitiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol Easibreathe |
| IPDI salbutamol MDI | – | Drug: Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI deviceinitiate ICS therapy as BDP Easibreathe at the index date and also receive salbutamol MDI |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asthma patients on SABA therapy (any available) monotherapy who, at the index date, either: (i) IPDI: initiate ICS therapy as BDP EB at the index date and also receive reliever therapy as either*: * Salbutamol EB, or * Salbutamol MDI, OR, who (ii) IPDA: receive a recorded increase in ICS therapy as BDP EB at the index date and also receive reliever therapy as either*: * Salbutamol EB, or * Salbutamol MDI.
Key inclusion criteria (11 listed)
- Aged: 4-80 years:
- Evidence of asthma:
- Be on current asthma therapy (for the IPDA cohort only):
- 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 (4 listed)
- had a COPD read code at any time; and/or
- received a combination inhaler in addition to a separate ICS inhaler in the baseline year; and/or
- received a long-acting beta2-agonsist (LABA) in addition to a separate ICS inhaler in the baseline year
- received ICS therapy during baseline year via DPI (in IPDA cohort only).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device | Drug | IPDI salbutamol EB |
| Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device | Drug | IPDI salbutamol MDI |
| Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device | Drug | IPDA salbutamol EB |
| Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI | Drug | IPDA salbutamol MDI |
Primary outcome
Proxy asthma control
Time frame: One-year outcome period
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 steroids, AND * No GP consultations, hospital admissions or A\&E attendance for lower respiratory tract infections (LRTI) requiring antibiotics.
Total number of asthma exacerbations and exacerbation rate ratio
Time frame: One-year outcome period
Where exacerbation is defined as an occurrence of: * Unscheduled hospital admissions / A\&E attendance for asthma, OR * Use of oral steroids
3 secondary outcomes
Treatment success 1
Time frame: One-year outcome period
Treatment success 2 (independent of possible cost savings)
Time frame: One-year outcome period
Respiratory-related hospitalisations and referrals.
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 2011.
- 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 16495040Crompton GK, Barnes PJ, Broeders M, Corrigan C, Corbetta L, Dekhuijzen R, Dubus JC, Magnan A, Massone F, Sanchis J, Viejo JL, Voshaar T; Aerosol Drug Management Improvement Team. The need to improve inhalation technique in Europe: a report from the Aerosol Drug Management Improvement Team. Respir Med. 2006 Sep;100(9):1479-94. doi: 10.1016/j.rmed.2006.01.008. Epub 2006 Feb 21.
- 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 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 10868714Lenney J, Innes JA, Crompton GK. Inappropriate inhaler use: assessment of use and patient preference of seven inhalation devices. EDICI. Respir Med. 2000 May;94(5):496-500. doi: 10.1053/rmed.1999.0767.
- Background: PubMed 14572322Molimard M, Raherison C, Lignot S, Depont F, Abouelfath A, Moore N. Assessment of handling of inhaler devices in real life: an observational study in 3811 patients in primary care. J Aerosol Med. 2003 Fall;16(3):249-54. doi: 10.1089/089426803769017613.
- Background: PubMed 11701099Brocklebank D, Ram F, Wright J, Barry P, Cates C, Davies L, Douglas G, Muers M, Smith D, White J. Comparison of the effectiveness of inhaler devices in asthma and chronic obstructive airways disease: a systematic review of the literature. Health Technol Assess. 2001;5(26):1-149. doi: 10.3310/hta5260.
- Background: PubMed 11668133Brocklebank D, Wright J, Cates C. Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering corticosteroids in asthma. BMJ. 2001 Oct 20;323(7318):896-900. doi: 10.1136/bmj.323.7318.896.
- Background: PubMed 15654001Dolovich MB, Ahrens RC, Hess DR, Anderson P, Dhand R, Rau JL, Smaldone GC, Guyatt G; American College of Chest Physicians; American College of Asthma, Allergy, and Immunology. Device selection and outcomes of aerosol therapy: Evidence-based guidelines: American College of Chest Physicians/American College of Asthma, Allergy, and Immunology. Chest. 2005 Jan;127(1):335-71. doi: 10.1378/chest.127.1.335.
- 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 11 inclusion and 4 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 2011. 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). 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 NCT01313585, 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 2011.