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The Supported Studies Programme

Classic & Established (Marketed)

The following areas are of particular interest to the review committee. These were last updated in January 2021.

• Understand burden of Allergic Rhinitis
• Allergic Rhinitis- Diagnosis and management
• Fluticasone Furoate nasal spray in Allergic Rhinitis management
• Role of sensory attributes in the management of Allergic Rhinitis- Use of intranasal corticosteroids
• Levocetirizine in management of Allergic Rhinitis and Urticaria
• Link between Allergic Rhinitis and Asthma- Impact of appropriate Allergic Rhinitis management on Asthma control

• Androgenetic alopecia: Sexual dysfunction associated with 5ARI/alpha blocker therapy as a barrier to optimal treatment management in androgenetic alopecia
• Androgenetic alopecia: post hair-transplant treatment with dutasteride/5ARIs (Alpha Reductase Inhibitors)

Research proposals addressing barriers to optimal treatment management including exploration of real world clinical practice data and patient outcomes:
• 5ARI/alpha blocker combination vs alpha blocker monotherapy in BPH treatment paradigm - pros and cons of differential therapeutic approaches in moderate to severe LUTS/BPH
• Evaluation, management and monitoring of Lower urinary tract symptoms/ benign prostatic hypertrophy (LUTS/BPH) in driving optimal treatment outcomes in benign prostatic hypertrophy benign prostatic hypertrophy (BPH) patients
• Sexual dysfunction associated with 5ARI/alpha blocker therapy as a barrier to optimal treatment management in benign prostatic hypertrophy (BPH)
• Understanding risk of progression in benign prostatic hypertrophy (BPH) patients - role of urodynamic and mechanistic aspects

• Real world evidence indicating assessment of adherence to 5ARI monotherapy or 5ARI/alpha blocker combination for BPH management

[Infectious Diseases]
• Proposals supporting appropriate antibiotic prescribing (dose, duration, PK/ PD- pharmacokinetic/ pharmacodyn principles)
• Antibiotic stewardship
• Strategies to minimise development of antimicrobial resistance in the community

• Registry or database studies to track prescription trends and assess clinical outcome

Products: Salmeterol plus fluticasone, fluticasone and salbutamol, fluticasone furoate plus vilanterol

Epidemiology of asthma, disease progression parameters and asthma management:

•What are the parameters indicating asthma disease progression (mild to moderate and beyond)?
•Studies that help in characterisation of patients whose disease progresses vs those that do not progress.
•Efficacy/Effectiveness of Regular maintenance dosing ICS containing therapies + SABA prn (Inhaled corticosteroid/ inhaled corticosteroid-long acting beta agonist combination + short acting beta agonists PRN) in asthma control and reducing the risk of exacerbation endpoints (lung function, control and reducing the risk of exacerbation) – adults and paediatric population
•Exploring patient behaviour in relation to adherence in asthma and asthma control
•Patient perspectives with respect to symptoms perception and control

Understanding RWE in asthma disease and asthma management using registries or database studies:

•To track patients' journey through the health system to look at differences between regular daily ICS/ICS+LABA and other treatment regimens in asthma (including paediatrics and adult asthma).
•Observational studies/ RWE/ database evidence/ others on proactive regular dosing vs variable dosing regimen (MART or PRN) with respect to clinical outcomes and/ or patient reported outcomes in asthma
•Use of Registries or databases to track post Emergency Department (ED) discharge follow-up, treatment & patient journey in patients of asthma
•To track patients' disease progression journey when initiated on various treatments in mild asthma and/or moderate asthma (SABA PRN, regular mono ICS or ICS/LABA with SABA PRN as prescribed)
•Studies to characterise inflammatory profile/phenotype of asthma exacerbations/cluster analysis to identify endotypes or phenotypes of patients that exacerbate
• Studies looking at longitudinal trajectory of airway inflammation in mild asthma using inflammatory markers (example- blood/sputum eosinophils FeNO)

Adherence/ patient support programmes:
•Studies linking improved adherence with improved outcomes in paediatric / adult asthma patients e.g. Interventions with Apps and other tools
•Studies to understand patient behaviours around non-adherence

•Scientific data in novel clinical strategies for mild to moderate asthma management that adds value to patient care (in light of the current unprecedented circumstances)

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