Severe allergic asthma (consistent with the licence for omalizumab). Respiratory Asthma
Conditions
Interventions
This study will investigate patients who are prescribed omalizumab treatment as part of routine clinical practice. Retrospective and prospective clinical assessments will be undertaken by a member of
Sponsors
Novartis Pharmaceuticals (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient to receive at least one dose of omalizumab for the treatment of severe persistent allergic asthma as part of normal clinical care 2. Patient aged 16 or over at initiation of omalizumab
Exclusion criteria
Exclusion criteria: 1. Complete patient medical record for the 12 months pre-initiation of omalizumab is not available for review 2. Medical record contains insufficient data to complete the baseline study dataset (for patients recruited to the study after omalizumab initiation) 3. Patient declines to consent to research access to the medical record and/or researcher contact with the GP to obtain a complete study dataset 4. Previous bronchial thermoplasty 5. Previous omalizumab use 6. Current participation in any interventional trial of asthma treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the mean (SD) daily dose of OCS per patient in the 12 months pre- versus post-initiation of omalizumab and its 95% confidence interval (CI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The difference in lung function (FEV1 % predicted) at baseline versus 16 weeks, 8 months and 12 months post-initiation of omalizumab 2. The difference in patient reported outcomes (scales ACT & AQLQ) at baseline versus 16 weeks, 8 months and 12 months post-initiation of omalizumab 3. The difference in mean (SD) NHS secondary care resource utilisation in the 12 months pre- versus the 12 months post-initiation of omalizumab 4. The proportion of patients stopping, the proportion reducing and the proportion stopping OR reducing OCS within 12 months following initiation of omalizumab 5. The correlation coefficient between stopping OCS ang change in AQLQ from baseline to 16 weeks, 8 months and 12 months post-initiation of omalizumab 6. The difference in the number of documented asthma exacerbations in the 12 months pre- versus the 12 months post-initiation of omalizumab 7. The correlation coefficient betweeen change in number of exacerbations and change in lung function from basline to 16 weeks, 8 months and 12 months post-initiation of omalizumab 8. The difference in the number of working/education days lost in the 12 months pre versus the 12 months post-initiation of omalizumab 9. Distribution of concomitant steroid-sparing asthma medications in the 12 months pre versus the 12 months post-initiation of omalizumab treatment 10. The proportion of patients in whom initiation of omalizumab was compliant with NICE (English and Welsh centres) and SMC (Scottish centres) criteria for omalizumab use 11. The proportion of patients classed by the clinician as 'responders' to omalizumab treatment at 16 weeks 12. Distribution of characteristics of patients who have been prescribed omalizumab in normal clinical priactice (age, sex, race, smoking status, height, weight, allergies and co morbidities at baseline) 13. The difference in patient weight at baseline and12 months post-omalizumab initiation | — |
Countries
United Kingdom
Outcome results
None listed