Status: Finalised
First registered on:
31/03/2015
Last updated on:
23/10/2018
1. Study identification
EU PAS Register NumberEUPAS9142
Official titleCharacterising patients and examining real-life outcomes for UK patients with COPD initiating on or changing to Fostair
Study title acronymREACH II
Study typeObservational study
Brief description of the studyTwo-stage historical cohort study to evaluate, in a comparative effectiveness study, whether Fostair pMDI is non-inferior, in terms of COPD exacerbation prevention, to other fixed dose combination (FDC) inhaled corticosteroid (ICS) / long-acting beta agonist (LABA) COPD therapies.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/02/201510/02/2015
Start date of data collection07/04/201507/04/2015
Start date of data analysis20/04/201520/04/2015
Date of interim report, if expected01/09/201701/09/2017
Date of final study report11/09/201505/09/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesChiesi Ltd100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Wan Yau Ming
First name Simon
Address line 116 Raffles Quay
Address line 2#33-03
Address line 3Hong Leong Building
CitySingapore
Postcode048581
CountrySingapore
Phone number (incl. country code)441223967829
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Wan Yau Ming
First name Simon
Address line 116 Raffles Quay
Address line 2#33-03
Address line 3Hong Leong Building
CitySingapore
Postcode048581
CountrySingapore
Phone number (incl. country code)441223967829
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameFostair pMDI
CountryUnited Kingdom
Substance INN(s)BECLOMETASONE DIPROPIONATE
FORMOTEROL FUMARATE
7. Medical conditions to be studied
Medical condition(s)Yes
Chronic obstructive pulmonary disease
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects80000
Additional information
80000 for stage 1 and 1200 for stage 2
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To evaluate whether beclomethasone/formoterol (Fostair pMDI) is non-inferior in terms of COPD exacerbation prevention, to other fixed dose combination inhaled corticosteroid/long-acting beta agonist COPD therapies.
Are there primary outcomes?Yes
The proportion of patients with no COPD exacerbations in the outcome period.
Are there secondary outcomes?Yes
Respiratory outcomes for Fostair pMDI relative to other COPD therapies considered (please see full protocol for details) and cost-effectiveness outcomes for Fostair pMDI relative to other COPD therapies considered (please see full protocol for details)
13. Study design
What is the design of the study?
Cohort study
Historical cohort database study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10
Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and by therapy. Treatment groups will be compared using t-test / Mann Whitney U-test (depending on distribution) for variables measured on the interval/ratio scale and using a chi square test for categorical variables.
Outcomes analyses: patients may be matched on demographics and key measures of
disease severity to minimise confounding, using random selection process through SAS statistical software to avoid selection bias.
To show non-inferiority in exacerbation prevention, the adjusted proportions of patients within each treatment group, recording no exacerbations in the outcome period will be calculated using a generalised linear model with binomial distribution and logit link.
95% confidence interval will be reported.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
