Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Medical condition to be studied

Asthma
Population studied

Short description of the study population

Patients having a current asthma diagnosis and not having diagnosed COPD.
Patients must meet the following inclusion criteria:
1. Aged 16+ years at the date of their iHARP review
2. Receiving current asthma therapy as FDC ICS/LABA:
o ≥1 prescriptions for FDC ICS/LABA in the year prior to review via: DPI or MDI with or without a spacer device
3. Completed asthma review during which full study-relevant data were recorded, meeting standards of IPCRG, Global Initiative for Asthma (GINA) guidelines and
Quality and Outcomes Framework (QOF) recommendations

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Asthma patients

Estimated number of subjects

5000
Study design details

Main study objective

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.

Outcomes

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, 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”)

Data analysis plan

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