AsthmaFos/Ser_switchNCT01242098
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
An observational study of Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this study is 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fixed dose combination salmeterol / fluticasone and Fixed-dose combination beclometasone dipropionate / formoterol
- How many people
- 137 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Dec 2011
- 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: Patients receiving ICS/LABA therapy as FP/SAL (Seretide® 125) who, at an index prescription date (IPD) receive a routine asthma review* and either: (i) Switched to BDP/FOR (Fostair®)at same or lower BDP-equivalent ICS dose; OR, (ii) Continues on FP/SAL (Seretide® 125) for the duration of the outcome period at the same or lower BDP-equivalent ICS dose prescribed at baseline.
Who may be able to join
- Aged:
- 18-60 years:
- 61-80 years who are never-smokers
- Evidence of asthma:
- a diagnostic code for asthma, or
- ≥2 prescriptions for asthma at different points in time during the prior year
- Baseline FP/SAL therapy:
- ≥2 prescription for ICS/LABA therapy as FP/SAL (Seretide® 125).
Who cannot join
- Any chronic respiratory disease other than asthma
- Are receiving maintenance oral steroid therapy during baseline period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK Primary Care Asthma Management
The purpose of this study is 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.
- Conditions
- Asthma
- Being tested
- Fixed dose combination salmeterol / fluticasone, Fixed-dose combination beclometasone dipropionate / formoterol
- Keywords
- Asthma, Combination therapy, Primary care management, Switch, ICS/LABA, 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.
Fixed dose combination salmeterol / fluticasoneDrug
Also called FP/SAL; Seretide® 125
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
Fixed-dose combination beclometasone dipropionate / formoterolDrug
Also called BDP/FOR; Fostair® 100/6
Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
| Study group | Role | What they receive |
|---|---|---|
| Fostair switch cohort | Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair Receives: Drug: Fixed-dose combination beclometasone dipropionate / formoterol | |
| Seretide continuation cohort | Seretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide Receives: Drug: Fixed dose combination salmeterol / fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation rate
Where an exacerbation is defined as:
(i) Asthma-related
- Hospital attendance / admissions OR
- Accident \& Emergency (A\&E) attendance OR (ii) Use of oral steroids.
Measured: One-year outcome period
Secondary outcomes (8)
Exacerbation control (a composite proxy measure)
Controlled:
Absence of:
(i) Asthma-related:
- Hospital attendance or admission
- A\&E attendance, OR
- Out of hours consultations, OR
- Out-patient department attendance (ii) GP consultations for lower respiratory tract infection (iii) Prescriptions for acute courses of oral steroids
Measured: One-year outcome period
Treatment success 1
(i) Exacerbation control
AND
(ii) No change in therapeutic regimen:
- ≥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: One-year outcome period
Asthma hospitalisations
- 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
Measured: One-year outcome period
Compliance with ICS/LABA therapy
Compliance calculation based on prescription refills and (where possible) compliance questionnaire data
Measured: One-year outcome period
Use of reliever medication
average daily dosage during outcome year. Outcome SABA usage will be categorised within ranges used to match baseline SABA use to optimise matching of the treatment arms.
Measured: One-year outcome period
Cost of therapeutic regimen.
Mean healthcare costs (drug costs + consultation, admission costs, etc - total and respiratory-related) per patient recorded during the outcome year
Measured: One-year outcome period
Asthma-related / respiratory hospitalisations
- Definite: Hospitalisations coded with a lower respiratory code
- 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: one year outcome period
Oral Thrush
Identified as:
(i) Topical oral anti-fungal prescriptions, and / or
(ii) Coded for oral candidiasis
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 posted16 Nov 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
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
- 137 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, Alison Chisholm, Research in Real-Life Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242098
- Sponsor's protocol ID
- 004/11
- Acronym
- Fos/Ser_switch
- Status last verified
- Jun 2012
- First submitted
- 11 Nov 2010
- Last updated
- 8 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK Primary Care Asthma Management
- ClinicalTrials.gov ID
- NCT01242098
- Acronym / sponsor ID
- Fos/Ser_switch / 004/11
- Conditions
- Asthma
- Keywords
- Asthma, Combination therapy, Primary care management, Switch, ICS/LABA, Fostair, Seretide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Chiesi Farmaceutici S.p.A.
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 16 Nov 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 purpose of this study is 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fostair switch cohort | – | Drug: Fixed-dose combination beclometasone dipropionate / formoterolSeretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and switch to Fostair |
| Seretide continuation cohort | – | Drug: Fixed dose combination salmeterol / fluticasoneSeretide patients who, at an index date, had a step down in therapy (reduction in ICS dose of ≥50%) and continue on Seretide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving ICS/LABA therapy as FP/SAL (Seretide® 125) who, at an index prescription date (IPD) receive a routine asthma review* and either: (i) Switched to BDP/FOR (Fostair®)at same or lower BDP-equivalent ICS dose; OR, (ii) Continues on FP/SAL (Seretide® 125) for the duration of the outcome period at the same or lower BDP-equivalent ICS dose prescribed at baseline.
Key inclusion criteria (8 listed)
- Aged:
- Evidence of asthma:
- Baseline FP/SAL therapy:
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 |
|---|---|---|
| Fixed dose combination salmeterol / fluticasoneAlso: FP/SAL; Seretide® 125Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy | Drug | Seretide continuation cohort |
| Fixed-dose combination beclometasone dipropionate / formoterolAlso: BDP/FOR; Fostair® 100/6Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy | Drug | Fostair switch cohort |
Primary outcome
Exacerbation rate
Time frame: One-year outcome period
Where an exacerbation is defined as: (i) Asthma-related 1. Hospital attendance / admissions OR 2. Accident \& Emergency (A\&E) attendance OR (ii) Use of oral steroids.
8 secondary outcomes
Exacerbation control (a composite proxy measure)
Time frame: One-year outcome period
Treatment success 1
Time frame: One-year outcome period
Asthma hospitalisations
Time frame: One-year outcome period
Compliance with ICS/LABA therapy
Time frame: One-year outcome period
Use of reliever medication
Time frame: One-year outcome period
Cost of therapeutic regimen.
Time frame: One-year outcome period
Asthma-related / respiratory hospitalisations
Time frame: one year outcome period
Oral Thrush
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 8 Jun 2012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 8 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 8 Jun 2012. 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?
Exacerbation rate (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?
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 8 Jun 2012.