AsthmaREACHNCT01908075
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
An observational study of Asthma, run by Research in Real-Life Ltd.
Trial summary
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- FP/SAL and BDP/FOR
- How many people
- 194,723 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients are diagnosed with asthma or COPD and aged between 18-80 years with all 61-80 year olds being non-smokers only
Who may be able to join
- Aged: 18-80 years 61-80 years to be non-smokers only
- Evidence of asthma: a diagnostic code for asthma or two scripts for asthma..
- Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL
- Evidence of Continuing Therapy: Include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). UK average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of "real-life" data.
- Evidence of Switching for economic reasons: FP/SAL patients from practices with ≥5 switches to Fostair in a 3 month period to minimise data taken from switching of anomalous patients; optimal practices for inclusion are those switching "wholesale" for economic reasons.
Who cannot join
- Any chronic respiratory disease other than asthma
- Are receiving maintenance oral steroid therapy during baseline period
About this study
Official title: REACH Fostair vs Seretide - Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.
Read the detailed description
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched. To evaluate respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database (in patients switched for cost rather than clinical reasons).
- Conditions
- Asthma
- Being tested
- FP/SAL, BDP/FOR
- Keywords
- Primary care, Asthma management, Real-world, Observational, Fostair, Seretide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP/SALDrug
Also called Seretide®
BDP/FORDrug
Also called Fostair® 100/6
| Study group | Role | What they receive |
|---|---|---|
| BDP/FOR | Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose Receives: Drug: FP/SAL; Drug: BDP/FOR | |
| FP/SAL | Patients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose Receives: Drug: FP/SAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbations : rate ratio
Where an exacerbation is defined as:
(i) Asthma-related
- Hospital attendance / admissions OR
- Accident \& Emergency (A\&E) attendance OR (ii) Use of acute oral steroids.
Where:
- ≥1 oral steroid prescription occurs within 2 weeks of another, or
- ≥1 hospitalisation occurs within 2 weeks of another, or
- ≥1 hospitalisation occurs within 2 weeks of an oral steroid prescription
Measured: 1 year
Secondary outcomes (6)
Exacerbation control
Proxy Asthma Control. The absence of exacerbation and the absence of antibiotic prescribing for lower respiratory tract infections (often a pragmatic prescribing decision taken by GPs in real world practice).
Controlled:
(i) No Asthma-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
Uncontrolled:
(i) All others.
- Proxy Asthma Control + SABA As above, but with an additional criterion that limits "controlled" patients to those who use ≤200mcg salbutamol daily.
Measured: 1 year
Proxy asthma control + SABA
As above, but with an additional criterion that limits "controlled" patients to those who use ≤200mcg salbutamol daily
Measured: 1 year
Treatment success
No exacerbation and no change in therapy during the outcome year, where changes are:
•≥50% increase in ICS dose relative to IPD dose, and/or
- Change in ICS/LABA drug within class, and/or
- Change in delivery device, and/or
- Use of additional (defined as not received during baseline year) therapy as defined by: theophylline, leukotriene receptor antagonists (LTRAs).
Measured: 1 year
Asthma Control (including SABA)
Defined as proxy asthma control (above) plus:
Average daily prescribed dose of ≤200mcg salubtamol / ≤500mcg terbutaline
Measured: 1 year
Hospitalisations
Asthma-related hospitalizations
- Definite: Hospitalisations coded with an asthma read code
- Definite + Probable: 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
Respiratory hospitalisations
- Definite: Hospitalisations coded with a lower respiratory code relevant for Paeds (for example J450)
- Definite + Probable: Hospitalisations with an asthma read code + uncoded hospitalisations occurring within a 7-day window (either side of the hospitalisation date) of a lower respiratory read code
Measured: 1 year
Medication possession ratio
For ICS, defined as the number of days supply of ICS / 365 x 100%
Controller/reliever ratio: number of controller units/ number of controller units + number of reliever units. Controllers are defined as ICS (including fixed combination ICS/LABA) and LTRA, while relievers are SABA. For ICS a unit is taken to be one inhaler; for LTRA a unit is one prescription.
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 posted25 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 194,723 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Responsible party
- Principal investigator, David Price, Prof., MD, Research in Real-Life Ltd
- Investigators
- David Price, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908075
- Sponsor's protocol ID
- R04312
- Acronym
- REACH
- Status last verified
- Jul 2013
- First submitted
- 23 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH Fostair vs Seretide - Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
- ClinicalTrials.gov ID
- NCT01908075
- Acronym / sponsor ID
- REACH / R04312
- Conditions
- Asthma
- Keywords
- Primary care, Asthma management, Real-world, Observational, Fostair, Seretide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194,723 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched.
Detailed description
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide®) in matched asthma patients switching to BDP/FOR following treatment with FP/SAL in normal clinical practice compared with patients not switched. To evaluate respiratory outcomes for Fostair in comparison to Seretide using a UK primary care database (in patients switched for cost rather than clinical reasons).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BDP/FOR | – | Drug: FP/SAL, Drug: BDP/FORPatients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD): Change their therapy to BDP/FOR (Fostair®) at same or lower BDP-equivalent ICS dose |
| FP/SAL | – | Drug: FP/SALPatients receiving ICS/LABA therapy as FP/SAL (Seretide®) who, at an index prescription date (IPD) : Remain on FP/SAL at the same BDP-equivalent ICS dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are diagnosed with asthma or COPD and aged between 18-80 years with all 61-80 year olds being non-smokers only
Key inclusion criteria (5 listed)
- Aged: 18-80 years 61-80 years to be non-smokers only
- Evidence of asthma: a diagnostic code for asthma or two scripts for asthma..
- Baseline FP/SAL therapy: ≥2 prescription for ICS/LABA therapy as FP/SAL
- Evidence of Continuing Therapy: Include only patients who receive ≥2 prescriptions for the therapy under study during the outcome year (i.e. ≥1 prescription at the index date and ≥1 other). UK average is 3-4 prescriptions refilled per year, so ≥2 ensures capture of "real-life" data.
- Evidence of Switching for economic reasons: FP/SAL patients from practices with ≥5 switches to Fostair in a 3 month period to minimise data taken from switching of anomalous patients; optimal practices for inclusion are those switching "wholesale" for economic reasons.
Key exclusion criteria (2 listed)
- Any chronic respiratory disease other than asthma
- Are receiving maintenance oral steroid therapy during baseline period
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 |
|---|---|---|
| FP/SALAlso: Seretide® | Drug | BDP/FOR, FP/SAL |
| BDP/FORAlso: Fostair® 100/6 | Drug | BDP/FOR |
Primary outcome
Exacerbations : rate ratio
Time frame: 1 year
Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. Accident \& Emergency (A\&E) attendance OR (ii) Use of acute oral steroids. Where: * ≥1 oral steroid prescription occurs within 2 weeks of another, or * ≥1 hospitalisation occurs within 2 weeks of another, or * ≥1 hospitalisation occurs within 2 weeks of an oral steroid prescription
6 secondary outcomes
Exacerbation control
Time frame: 1 year
Proxy asthma control + SABA
Time frame: 1 year
Treatment success
Time frame: 1 year
Asthma Control (including SABA)
Time frame: 1 year
Hospitalisations
Time frame: 1 year
Medication possession ratio
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 25 Jul 2013.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Price principal investigator
University of Aberdeen
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Research in Real-Life Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exacerbations : rate ratio (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2013.