S95 Double-blind Multi-centre Randomised Controlled Trial Of Vitamin D3 Supplementation In Adults With Inhaled Corticosteroid-treated Asthma (vidias)

Abstract

Aim This multicentre observational study was conducted to confirm the observed retrospective findings prospectively in UK clinical practice. Methods Retrospective data were collected in the 12 months prior to and prospective data for up to 12 months following omalizumab initiation. The primary endpoint was the change in mean daily OCS dosage (reported previously). Secondary endpoints included changes in mean exacerbation frequency (defined as requiring hospital admission or Accident and Emergency (A&E) attendance and/or a course of OCS (dosage increase of at least 10 mg/day for at least 3 days)), healthcare utilisation and missed days in education or at work. Results 235 patients were enrolled in the study at end December 2013 in 22 UK centres. Data for interim analysis were examined from patients with 12 months of assessment at database lock (n = 85, females, 54%, mean (±SD) age 44 yr (±13.2), mean (±SD) duration of asthma 26 yr (±14.0)). At the 16 weeks assessment 74/85 (87%) patients were classified as responders to omalizumab treatment. Comparing the 12 month periods prior to and following initiation of omalizumab, mean total exacerbations decreased by 51% from (mean, ±SD) 4.25 ± 2.73 to 2.07 ± 2.01 (mean difference 2.18, p < 0.001), while mean exacerbations involving hospital visits decreased by 61% from 1.52 ± 2.00 to 0.59 ± 1.25 (difference 0.93, p < 0.001). A&E attendances were reduced from 54 to 19 (p < 0.01) and inpatient hospitalisations from 85 to 36 (p < 0.001). The percentage of average days absent from work or education due to sickness was more than halved in the 12 months pre and post omalizumab initiation reducing from 19.6% to 7.72% (n = 27, p < 0.05). Conclusions The data prospectively confirms that omalizumab is associated with significant reduction in exacerbations, healthcare utilisation and societal burden in severe allergic asthma patients as was reported in the retrospective study. S94A Background A previous retrospective study of UK clinical practice demonstrated that omalizumab reduced OCS burden. Aim This multi-centre observational study was conducted to confirm the observed retrospective findings prospectively. Methods Retrospective data were collected in the 12 months prior to omalizumab, while prospective data were collected at 16 weeks, 8 and 12 months following initiation. The primary endpoint was the change in mean daily OCS dose in the 12 months pre and post omalizumab initiation. Secondary endpoints included changes in ACT and AQLQ scores in the 12 months pre and post omalizumab initiation. Results 235 patients were enrolled by the end December 2013 in 22 UK centres. Data for interim analysis were examined from patients who had 12 months assessment at database lock (n = 85, 54% females, mean (±SD) age 44 yr (±13.2), mean (±SD) duration of asthma 26 yr (±14.0)). At the 16 weeks assessment 74/85 (87%) patients were classified as responders to omalizumab treatment. At 12 months, mean daily OCS dose decreased by 25% (n = 85, p < 0.001) from 10.77 mg/day (±7.87) to 8.08 mg/day (±8....

Vitamin D in respiratory diseases

“…[17] Similarly, a trial of bolus-dose vitamin D 3 supplementation did not influence exacerbation time for asthma or upper respiratory tract infections (URTIs) in adults with vitamin D deficiency. [18] A Cochrane meta-analysis recently showed that vitamin D supplementation does reduce the risk of severe exacerbations, and improves asthma symptom control in people with mild to moderate asthma. [19] Vitamin D and chronic obstructive pulmonary disease Low serum 25(OH)D 3 levels have been associated with lower forced expiratory volume in 1 second (FEV1), impaired immunological control, and increased airway inflammation.…”