Status: Finalised
First registered on:
05/05/2015
Last updated on:
16/01/2019
1. Study identification
EU PAS Register NumberEUPAS9651
Official titleCRITIKAL Study
Study title acronym
Study typeObservational study
Brief description of the studyTo assess the association between patient/treatment factors, including inhaler technique, lung function and comorbidities and asthma control in patients receiving fixed dose combination therapy (FDC), inhaled corticosteroids/long-acting beta agonists (ICS/LABA), ± short-acting beta2-agonist (SABA) therapy.
A further aim will be to identify errors in inhalation technique that constitute ‘critical errors’ defined as those that have an adverse effect on asthma control.
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 groupResearch in Real Life 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
International study
Australia
France
Italy
Netherlands
Norway
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/05/2010
Start date of data collection01/08/2011
Start date of data analysis
Date of interim report, if expected
Date of final study report01/05/201609/05/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesmundiphama50
Charities
Government body
Research councils
EU funding scheme
OtherTeva10
Rirl40
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 1Rirl
Address line 2
Address line 3
CitySingapore
Postcode
CountrySingapore
Phone number (incl. country code)4401223967855
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 1University of Aberdeen
Address line 2
Address line 3
CityAberdeen
PostcodeAB24 3FX
CountryUnited Kingdom
Phone number (incl. country code)4401223967855
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Asthma
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 subjects5000
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
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 assess the associate between patient/treatment factors, including inhaler technique, lung function and comorbidities, in predicting asthma control in patients receiving fixed dose combination therapy (FDC), inhaled corticosteroids/long-acting beta agonists (ICS/LABA), ± short-acting beta2-agonist (SABA) therapy.
Are there primary outcomes?Yes
The GINA based asthma control categories (“controlled”, “partly controlled”, “uncontrolled”) with be assign based on the answers to 4 questions that correspond to the questions in the GINA guideline from 2015. Namely:Daytime symptoms (more than twice/week), Any night waking due to asthma, Needed reliever inhaler (more than twice/week), Any limitation to day time activity
Are there secondary outcomes?Yes
Similar to the analysis of the primary outcomes, numbers and percentages of patients will be cross-tabulated and compared across the categories of:
• Asthma risk assessment (“Higher risk”, “Moderate risk”, “Lower risk”)
• Adherence (both subjective and objective) with three categories (“Poor”, “Borderline”, ”Good”)
13. Study design
What is the design of the study?
Cross-sectional 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
Summary statistics will be produced for all explanatory and outcome variables for all the patients and for patients using the different types of inhaler devices (Diskus, Turbuhaler, MDI and MDI with spacers). For variables measured on the interval or ratio scale, these will include: Sample size (n), Percentage non-missing, Mean (Standard Deviation), Median (Inter-quartile range (25th and 75th percentiles))
For categorical variables, the summary statistics will include: Sample size (n), Count and percentage by category (distribution)
Univariate ordinal regression analyses will be carried out to identify those explanatory variables that are predictive (p < 0.05) of outcomes. These will be considered as potential confounders when modelling the outcome variables.
Muivariate analyses will be carried out to develop of model of the most important factors in asthma control
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
