P203 A comparison of adverse events associated with licensed and unlicensed spacer use with non-extrafine beclometasone dipropionate treatment in a real-life patient population with asthma in the uk

S Wan Yau Ming, J Haughney, D Ryan, S Patel, M Ochel, S Thornhill, D Price

Research output: Contribution to journalAbstract

2 Citations (Scopus)

Abstract

Background Spacers may be compatible but unlicensed for an inhaler device. A prior study showed that co-prescription of unlicensed spacers with non-extrafine (non-EF) beclometasone dipropionate (BDP) asthma therapy was common.1 This study aimed to compare the occurrence of patient-reported inhaled corticosteroid (ICS)-related adverse events (AEs) in patients with asthma co-prescribed the licensed Volumatic or unlicensed Aerochamber spacer with their non-EF BDP therapy.Method A cross-sectional study using completed questionnaires and data extracted from the Optimum Patient Care Research Database including patients with asthma, aged =2 prescriptions for non-EF BDP and co-prescription of either a Volumatic or Aerochamber spacer. Patient characterisation was performed for the year prior to receipt of the completed questionnaire. AEs captured via questionnaire included continual sore mouth/throat, oral thrush, hoarse voice, bruising, weight gain and cough. The primary outcome was non-inferiority of the proportion of patient-reported oral candidiasis (reported as oral thrush/hoarse voice). The two spacer groups were compared using logistic regression, adjusted for gender, ICS average dose and smoking status. Non-inferiority was claimed if the upper 95% confidence interval (CI) of the marginal effect estimate was lt;0.13. Comparisons by age (lt;16, 16textendash65,>=65 years) and ICS dose (lt;1000 textmug,>=1000 textmug) were additionally performed.Results Of the patients co-prescribed the licensed Volumatic spacer (n=155), 29.9% reported oral candidiasis, compared to 27.7% of patients co-prescribed the unlicensed Aerochamber device (n=385, p=0.622). The marginal effect estimate was -0.043 (95%CI -0.133, 0.047) and the Aerochamber was determined to be non-inferior to the Volumatic spacer. In terms of the total number of reported AEs, there were no significant differences for the main population (=65 years (p=0.425), high dose (p=0.084) and low dose (p=0.443) groups between those co-prescribed a Volumatic or an Aerochamber spacer.Conclusion Co-prescription of the unlicensed Aerochamber spacer with non-EF BDP asthma therapy, in recommended patient groups, does not increase the risk of developing oral candidiasis or other ICS-related AEs, as compared to co-prescription of the licensed, Volumatic device.ReferenceICARUS study submitted to PCRS2017.
Original languageEnglish
Pages (from-to)A193
JournalThorax
Volume72
Issue numberSuppl 3
DOIs
Publication statusPublished - 1 Dec 2017

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Beclomethasone
Oral Candidiasis
Asthma
Prescriptions
Population
Adrenal Cortex Hormones
Therapeutics
Equipment and Supplies
Confidence Intervals
Pharyngitis
Nebulizers and Vaporizers
Cough
Weight Gain
Mouth
Patient Care
Cross-Sectional Studies
Logistic Models
Smoking
Databases

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P203 A comparison of adverse events associated with licensed and unlicensed spacer use with non-extrafine beclometasone dipropionate treatment in a real-life patient population with asthma in the uk. / Ming, S Wan Yau; Haughney, J; Ryan, D; Patel, S; Ochel, M; Thornhill, S; Price, D.

In: Thorax, Vol. 72, No. Suppl 3, 01.12.2017, p. A193.

Research output: Contribution to journalAbstract

@article{65d47d6446bb466e82dbccb0b1c8a792,
title = "P203 A comparison of adverse events associated with licensed and unlicensed spacer use with non-extrafine beclometasone dipropionate treatment in a real-life patient population with asthma in the uk",
abstract = "Background Spacers may be compatible but unlicensed for an inhaler device. A prior study showed that co-prescription of unlicensed spacers with non-extrafine (non-EF) beclometasone dipropionate (BDP) asthma therapy was common.1 This study aimed to compare the occurrence of patient-reported inhaled corticosteroid (ICS)-related adverse events (AEs) in patients with asthma co-prescribed the licensed Volumatic or unlicensed Aerochamber spacer with their non-EF BDP therapy.Method A cross-sectional study using completed questionnaires and data extracted from the Optimum Patient Care Research Database including patients with asthma, aged =2 prescriptions for non-EF BDP and co-prescription of either a Volumatic or Aerochamber spacer. Patient characterisation was performed for the year prior to receipt of the completed questionnaire. AEs captured via questionnaire included continual sore mouth/throat, oral thrush, hoarse voice, bruising, weight gain and cough. The primary outcome was non-inferiority of the proportion of patient-reported oral candidiasis (reported as oral thrush/hoarse voice). The two spacer groups were compared using logistic regression, adjusted for gender, ICS average dose and smoking status. Non-inferiority was claimed if the upper 95{\%} confidence interval (CI) of the marginal effect estimate was lt;0.13. Comparisons by age (lt;16, 16textendash65,>=65 years) and ICS dose (lt;1000 textmug,>=1000 textmug) were additionally performed.Results Of the patients co-prescribed the licensed Volumatic spacer (n=155), 29.9{\%} reported oral candidiasis, compared to 27.7{\%} of patients co-prescribed the unlicensed Aerochamber device (n=385, p=0.622). The marginal effect estimate was -0.043 (95{\%}CI -0.133, 0.047) and the Aerochamber was determined to be non-inferior to the Volumatic spacer. In terms of the total number of reported AEs, there were no significant differences for the main population (=65 years (p=0.425), high dose (p=0.084) and low dose (p=0.443) groups between those co-prescribed a Volumatic or an Aerochamber spacer.Conclusion Co-prescription of the unlicensed Aerochamber spacer with non-EF BDP asthma therapy, in recommended patient groups, does not increase the risk of developing oral candidiasis or other ICS-related AEs, as compared to co-prescription of the licensed, Volumatic device.ReferenceICARUS study submitted to PCRS2017.",
author = "Ming, {S Wan Yau} and J Haughney and D Ryan and S Patel and M Ochel and S Thornhill and D Price",
year = "2017",
month = "12",
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doi = "10.1136/thoraxjnl-2017-210983.345",
language = "English",
volume = "72",
pages = "A193",
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issn = "0040-6376",
publisher = "BMJ Publishing Group Ltd",
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T1 - P203 A comparison of adverse events associated with licensed and unlicensed spacer use with non-extrafine beclometasone dipropionate treatment in a real-life patient population with asthma in the uk

AU - Ming, S Wan Yau

AU - Haughney, J

AU - Ryan, D

AU - Patel, S

AU - Ochel, M

AU - Thornhill, S

AU - Price, D

PY - 2017/12/1

Y1 - 2017/12/1

N2 - Background Spacers may be compatible but unlicensed for an inhaler device. A prior study showed that co-prescription of unlicensed spacers with non-extrafine (non-EF) beclometasone dipropionate (BDP) asthma therapy was common.1 This study aimed to compare the occurrence of patient-reported inhaled corticosteroid (ICS)-related adverse events (AEs) in patients with asthma co-prescribed the licensed Volumatic or unlicensed Aerochamber spacer with their non-EF BDP therapy.Method A cross-sectional study using completed questionnaires and data extracted from the Optimum Patient Care Research Database including patients with asthma, aged =2 prescriptions for non-EF BDP and co-prescription of either a Volumatic or Aerochamber spacer. Patient characterisation was performed for the year prior to receipt of the completed questionnaire. AEs captured via questionnaire included continual sore mouth/throat, oral thrush, hoarse voice, bruising, weight gain and cough. The primary outcome was non-inferiority of the proportion of patient-reported oral candidiasis (reported as oral thrush/hoarse voice). The two spacer groups were compared using logistic regression, adjusted for gender, ICS average dose and smoking status. Non-inferiority was claimed if the upper 95% confidence interval (CI) of the marginal effect estimate was lt;0.13. Comparisons by age (lt;16, 16textendash65,>=65 years) and ICS dose (lt;1000 textmug,>=1000 textmug) were additionally performed.Results Of the patients co-prescribed the licensed Volumatic spacer (n=155), 29.9% reported oral candidiasis, compared to 27.7% of patients co-prescribed the unlicensed Aerochamber device (n=385, p=0.622). The marginal effect estimate was -0.043 (95%CI -0.133, 0.047) and the Aerochamber was determined to be non-inferior to the Volumatic spacer. In terms of the total number of reported AEs, there were no significant differences for the main population (=65 years (p=0.425), high dose (p=0.084) and low dose (p=0.443) groups between those co-prescribed a Volumatic or an Aerochamber spacer.Conclusion Co-prescription of the unlicensed Aerochamber spacer with non-EF BDP asthma therapy, in recommended patient groups, does not increase the risk of developing oral candidiasis or other ICS-related AEs, as compared to co-prescription of the licensed, Volumatic device.ReferenceICARUS study submitted to PCRS2017.

AB - Background Spacers may be compatible but unlicensed for an inhaler device. A prior study showed that co-prescription of unlicensed spacers with non-extrafine (non-EF) beclometasone dipropionate (BDP) asthma therapy was common.1 This study aimed to compare the occurrence of patient-reported inhaled corticosteroid (ICS)-related adverse events (AEs) in patients with asthma co-prescribed the licensed Volumatic or unlicensed Aerochamber spacer with their non-EF BDP therapy.Method A cross-sectional study using completed questionnaires and data extracted from the Optimum Patient Care Research Database including patients with asthma, aged =2 prescriptions for non-EF BDP and co-prescription of either a Volumatic or Aerochamber spacer. Patient characterisation was performed for the year prior to receipt of the completed questionnaire. AEs captured via questionnaire included continual sore mouth/throat, oral thrush, hoarse voice, bruising, weight gain and cough. The primary outcome was non-inferiority of the proportion of patient-reported oral candidiasis (reported as oral thrush/hoarse voice). The two spacer groups were compared using logistic regression, adjusted for gender, ICS average dose and smoking status. Non-inferiority was claimed if the upper 95% confidence interval (CI) of the marginal effect estimate was lt;0.13. Comparisons by age (lt;16, 16textendash65,>=65 years) and ICS dose (lt;1000 textmug,>=1000 textmug) were additionally performed.Results Of the patients co-prescribed the licensed Volumatic spacer (n=155), 29.9% reported oral candidiasis, compared to 27.7% of patients co-prescribed the unlicensed Aerochamber device (n=385, p=0.622). The marginal effect estimate was -0.043 (95%CI -0.133, 0.047) and the Aerochamber was determined to be non-inferior to the Volumatic spacer. In terms of the total number of reported AEs, there were no significant differences for the main population (=65 years (p=0.425), high dose (p=0.084) and low dose (p=0.443) groups between those co-prescribed a Volumatic or an Aerochamber spacer.Conclusion Co-prescription of the unlicensed Aerochamber spacer with non-EF BDP asthma therapy, in recommended patient groups, does not increase the risk of developing oral candidiasis or other ICS-related AEs, as compared to co-prescription of the licensed, Volumatic device.ReferenceICARUS study submitted to PCRS2017.

U2 - 10.1136/thoraxjnl-2017-210983.345

DO - 10.1136/thoraxjnl-2017-210983.345

M3 - Abstract

VL - 72

SP - A193

JO - Thorax

JF - Thorax

SN - 0040-6376

IS - Suppl 3

ER -