Status: Finalised
First registered on:
13/08/2019
Last updated on:
13/08/2019
1. Study identification
EU PAS Register NumberEUPAS30940
Official titleEffectiveness of Dymista® in patients with allergic rhinitis and asthma
Study title acronym
Study typeObservational study
Brief description of the studyA pre-post historical cohort study evaluating the effectiveness of a novel combination therapy of antihistamine and intranasal corticosteroid (Dymista®) on asthma-related outcomes among patients with allergic rhinitis and asthma multi-morbidity. The primary objective is to examine the effectiveness of Dymista® in terms of improving asthma control by comparing the number of acute respiratory events and other measures of asthma control in the year before and after initiation of Dymista®.
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 signed03/05/201925/02/2019
Start date of data collection24/05/201924/04/2019
Start date of data analysis24/05/201924/04/2019
Date of interim report, if expected
Date of final study report23/08/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMylan100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)442081233923
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)442081233923
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameDymista
CountryUnited Kingdom
Substance INN(s)FLUTICASONE PROPIONATE
AZELASTINE HYDROCHLORIDE
Substance class (ATC Code)R01 (NASAL PREPARATIONS)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
Rhinitis allergic
8. Population under study
Age
Adolescents (12 - 17 years)
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 subjects1188
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Risk assessment
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To examine the effectiveness of Dymista® in terms of improving asthma control by comparing the number of acute respiratory events and other measures of asthma control in the year before and after initiation of Dymista®.
Are there primary outcomes?Yes
Change in the number of acute respiratory events was defined as occurrence of any of the following events separately or together (occurrences within 14 days of each other were considered to belong to the same event).
Are there secondary outcomes?Yes
Change in the number of asthma exacerbations, GINA treatment step, asthma control (Risk Domain Asthma Control and Overall Asthma Control), average daily dose of SABA and control of asthma symptoms (GINA level control)
13. Study design
What is the design of the study?
pre-post historical cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
All patients which were followed one-year after the date of initiating Dymista® (outcome year).
15. Data analysis plan
Please provide a brief summary of the analysis method
Patients initiating Dymista® were identified. The number of acute respiratory events in the baseline year and outcome year were determined. The effectiveness of Dymista® on the number of acute respiratory events in the baseline year was compared with the number of events in the outcome year by using the Wilcoxon signed rank test (for paired data). The results were reported as the proportion of patients who improved, worsened and stayed stable in the number of, for instance, acute respiratory events.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
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
