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Medication Remaining In Discarded Metered Dose Inhalers Of Asthmatic Children
Abstracts AB179
J ALLERGY CLIN IMMUNOL VOLUME 133, NUMBER 2
Medication Remaining In Discarded Metered Dose Inhalers Of Asthmatic Children Dr. Wantida Dampanrat, MD1, Dr. Pasuree Sangsupawanich, MD2, Dr. Araya Yuenyongviwat, MD3; 1Prince Of Songkla University, Hatyai, Thailand, 2Prince Songkhlanagarind hospital, Hadyai, Thailand, 3Prince of Songkla University, Songkhla, Thailand. RATIONALE: Currently available metered dose inhalers (MDIs) do not track the remaining number of doses. Therefore, we assume that asthmatic children use their controller MDIs regularly and we estimate the time that MDIs should be discarded is the discard point labeled on the canister and box to prevent the use of empty MDIs. However, we hypothesized that some medication remained in the discarded MDIs. METHODS: Fluticasone propionate and budesonide were the controller MDIs used in this study. Children with asthma symptoms had a regular schedule to replace controller MDIs according to the discard point labeled on the canister. We asked asthmatic children attending our clinic from September 2012 to June 2013 to collect their discarded controller MDIs. The remaining medication in each discarded MDI was calculated from the canister weight. RESULTS: Forty discarded MDIs were collected from 22 asthmatic children. Twenty one discarded MDIs belonged to controlled asthmatic children and all of them were used until nearly empty (>95% of labeled dose). Eight discarded MDIs(42%) which belonged to uncontrolled asthmatic children had remaining medication more than 30% of the labeled doses. Medication remaining in discarded MDIs of uncontrolled asthmatic children was unpredictable (median 15%, labeled dose range 0%-74%). CONCLUSIONS: Nearly half of discarded MDIs of uncontrolled asthmatic children had remaining medication more than 30% of the labeled doses. Canister weight is a useful and reliable method to track a patient’s medication supply. This procedure should be implemented into the health care system to prevent discard of unused medication.
617
Defining Severe Asthma In Childhood: A Descriptive Multicenter Study In Turkey Bulent Enis Sekerel1, Dr. Ozge Soyer2, Fatih Celmeli3, Yakup Canitez3, Ozlem Keskin3, Demet Can3, Ferhat Catal3, Mehtap Kilic3, Burcin Nalbantoglu3, Nail Yologlu3, Suleyman T. Yavuz3, Belgin Guc3, Fadil Ozturk3, Gulbin Karakoc3, Suna Asilsoy3, Mehmet Kilic3, Cem Razi3, Dost Zeyrek3, Semanur Kuyucu3, Hasan Yuksel3, Omer Cevit3, Aysen Bingol3, Mehtap G. Yazicioglu3, Ayse Yenigun3; 1Hacettepe University, Pediatric Allergy Unit, Ankara, Turkey, 2Hacettepe University School of Medicine, Ankara, Turkey, 3TURPEDAS, Turkey. RATIONALE: Severe asthma causes significant burden in terms of morbidity and healthcare resource use. Moreover, it is a heterogeneous disease creating difficulty in discrimination/classification. METHODS: In order to define characteristics of children having high level of asthma treatment and burden, 23 asthma centers of the country recorded patients during one year period. 372 children with asthma were allocated and from those who fit either Severe Asthma Research Program (SARP) or Problematic Severe Asthma (PSA) criteria were defined as severe asthma and the remainder served as controls. RESULTS: According to the criteria of PSA and SARP, 135 and 77 were classified as severe asthma, respectively and majority of the latter group appeared to be a subgroup of PSA. Compared to control group (n:232, moderate asthma), patients in severe asthma group had higher school absenteeism, unscheduled healthcare resource use, admission to an emergency unit, hospitalizations and systemic corticosteroid use within last year and had lower scores for ACT/C-ACT and FEV1 (p<0.05). Patients classified as both PSA&SARP were younger than the patients classified only as PSA and had higher unscheduled healthcare resource use, admission to an emergency unit and lower ACT scores (p<0.05 for each). CONCLUSIONS: Children with severe asthma have significantly higher burden compared those with moderate asthma. The use of criteria of PSA for severe asthma causes inclusion of more patients compared the definition of SARP indicating the employment of a wider spectrum for the definition. The utility and value of definitions for severe asthma need to be further determined prospectively
618
The Pediatric Diagnostic Conundrum Of Chronic Respiratory Symptoms Zainab Kagen, MD1, Joel Ledbetter, MD2, Jennifer Hamm, MD3, Esther Wilson, MD4; 1University of Tennesee College of Medicine-Chattanooga, TN, 2University of Tennessee College of Medicine-Chattanooga, TN, 3 University of Tennesee College of Medicine-Chattanooga, 4University of Tennessee College of Medicine-Chattanooga. RATIONALE: This study describes the clinical findings and diagnoses associated with young children less than 24 months of age who presented to a pediatric pulmonologist with chronic cough and/or wheeze. We hypothesized the majority of these children would have a definitive diagnosis other than asthma. METHODS: The study was a retrospective chart review. Inclusion criteria included children less than 24 months of age referred to pediatric pulmonology at a medium-sized academic center between July 1, 2005 and June 30, 2011 for the evaluation of chronic cough and/or wheeze. Chronic cough defined as a daily cough that has persisted > 4 weeks. Data including age, gender, medications, results of diagnostic testing (i.e. swallow study), bronchoscopy, BAL results, cytopathology, and cultures were collected. RESULTS: While some children had multiple diagnoses, the most common diagnosis in this population was swallow dysfunction (51), followed by airway malacia (42), asthma (23), chronic wheezing (21), protracted bacterial bronchitis (19), slowly resolving pneumonia (10), viral-induced wheeze (10), viral-induced cough (8) and gastro-esophageal reflux (5). Other occasionally diagnosed conditions included pertussis, tracheo-esophageal fistula, transient hypogammaglobulinemia, and subglottic hemangioma. CONCLUSIONS: Allergy and asthma specialists must understand that swallowing dysfunction is a very common diagnosis in children less than 24 months of age presenting with chronic respiratory symptoms. In this review, only 23 out of 117 patients had a diagnosis of asthma. This analysis reveals the wide range of pediatric diagnoses associated with chronic respiratory symptoms, and emphasizes that wheezing children less than 24 months of age rarely have asthma.
619
Quantification Of The Wear-Off Effect Towards The End Of The Intravenous Immunoglobulin Infusion Interval: Pooled Data Analysis Mr. John-Philip Lawo1, Dr. Alphonse Hubsch2, Dr. Mikhail Rojavin, PhD3; 1CSL Behring GmbH, Marburg, Germany, 2CSL Behring AG, Berne, Switzerland, 3Clinical Research and Development, CSL Behring LLC, King of Prussia, PA. RATIONALE: Some patients with primary immunodeficiencies (PID) report increased frequencies of infections and/or fatigue at the end of their intravenous IgG (IVIG) dosing cycle. This study aimed to quantify the ‘‘wear-off’’ effect by analyzing efficacy endpoints throughout 3- or 4weekly IVIG dosing cycles. METHODS: The database included 132 patients (7482 data points) from Phase III trials of SandoglobulinÒ NF Liquid or PrivigenÒ. A binomial regression model for repeated measurements was used to compare infection probabilities during each week of the cycle. The compound symmetry correlation structure was used to account for within-subject correlation. To account for incubation periods of infections starting early after infusion, a 3-day shifted time interval analysis was performed. As this was a retrospective analysis for hypothesis generation, no adjustment of p-values due to multiplicity was performed. RESULTS: The probability of infection increased significantly in Week 4 compared to Week 1 of the 4-weekly cycle (ratio 1.55; p50.031). Although the same effect was observed for the 3-weekly cycle, the difference was not statistically significant (ratio 1.27; p50.362). With shifted time intervals, the number of days with infection increased moderately, but statistically significantly, at the end of both dosing cycles (3-weekly: ratio 1.13, p50.047; 4-weekly: ratio 1.13, p<0.001). No signs of wear-off were seen for days of hospitalization or absence from school/work. CONCLUSIONS: This analysis provides additional evidence for the existence of a ‘‘wear-off’’ effect in patients with PID. Possible ways of reducing the increased infection risk are shorter IVIG infusion intervals, increased IVIG dose and/or switch to subcutaneous therapy.
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J ALLERGY CLIN IMMUNOL VOLUME 133, NUMBER 2
Medication Remaining In Discarded Metered Dose Inhalers Of Asthmatic Children Dr. Wantida Dampanrat, MD1, Dr. Pasuree Sangsupawanich, MD2, Dr. Araya Yuenyongviwat, MD3; 1Prince Of Songkla University, Hatyai, Thailand, 2Prince Songkhlanagarind hospital, Hadyai, Thailand, 3Prince of Songkla University, Songkhla, Thailand. RATIONALE: Currently available metered dose inhalers (MDIs) do not track the remaining number of doses. Therefore, we assume that asthmatic children use their controller MDIs regularly and we estimate the time that MDIs should be discarded is the discard point labeled on the canister and box to prevent the use of empty MDIs. However, we hypothesized that some medication remained in the discarded MDIs. METHODS: Fluticasone propionate and budesonide were the controller MDIs used in this study. Children with asthma symptoms had a regular schedule to replace controller MDIs according to the discard point labeled on the canister. We asked asthmatic children attending our clinic from September 2012 to June 2013 to collect their discarded controller MDIs. The remaining medication in each discarded MDI was calculated from the canister weight. RESULTS: Forty discarded MDIs were collected from 22 asthmatic children. Twenty one discarded MDIs belonged to controlled asthmatic children and all of them were used until nearly empty (>95% of labeled dose). Eight discarded MDIs(42%) which belonged to uncontrolled asthmatic children had remaining medication more than 30% of the labeled doses. Medication remaining in discarded MDIs of uncontrolled asthmatic children was unpredictable (median 15%, labeled dose range 0%-74%). CONCLUSIONS: Nearly half of discarded MDIs of uncontrolled asthmatic children had remaining medication more than 30% of the labeled doses. Canister weight is a useful and reliable method to track a patient’s medication supply. This procedure should be implemented into the health care system to prevent discard of unused medication.
617
Defining Severe Asthma In Childhood: A Descriptive Multicenter Study In Turkey Bulent Enis Sekerel1, Dr. Ozge Soyer2, Fatih Celmeli3, Yakup Canitez3, Ozlem Keskin3, Demet Can3, Ferhat Catal3, Mehtap Kilic3, Burcin Nalbantoglu3, Nail Yologlu3, Suleyman T. Yavuz3, Belgin Guc3, Fadil Ozturk3, Gulbin Karakoc3, Suna Asilsoy3, Mehmet Kilic3, Cem Razi3, Dost Zeyrek3, Semanur Kuyucu3, Hasan Yuksel3, Omer Cevit3, Aysen Bingol3, Mehtap G. Yazicioglu3, Ayse Yenigun3; 1Hacettepe University, Pediatric Allergy Unit, Ankara, Turkey, 2Hacettepe University School of Medicine, Ankara, Turkey, 3TURPEDAS, Turkey. RATIONALE: Severe asthma causes significant burden in terms of morbidity and healthcare resource use. Moreover, it is a heterogeneous disease creating difficulty in discrimination/classification. METHODS: In order to define characteristics of children having high level of asthma treatment and burden, 23 asthma centers of the country recorded patients during one year period. 372 children with asthma were allocated and from those who fit either Severe Asthma Research Program (SARP) or Problematic Severe Asthma (PSA) criteria were defined as severe asthma and the remainder served as controls. RESULTS: According to the criteria of PSA and SARP, 135 and 77 were classified as severe asthma, respectively and majority of the latter group appeared to be a subgroup of PSA. Compared to control group (n:232, moderate asthma), patients in severe asthma group had higher school absenteeism, unscheduled healthcare resource use, admission to an emergency unit, hospitalizations and systemic corticosteroid use within last year and had lower scores for ACT/C-ACT and FEV1 (p<0.05). Patients classified as both PSA&SARP were younger than the patients classified only as PSA and had higher unscheduled healthcare resource use, admission to an emergency unit and lower ACT scores (p<0.05 for each). CONCLUSIONS: Children with severe asthma have significantly higher burden compared those with moderate asthma. The use of criteria of PSA for severe asthma causes inclusion of more patients compared the definition of SARP indicating the employment of a wider spectrum for the definition. The utility and value of definitions for severe asthma need to be further determined prospectively
618
The Pediatric Diagnostic Conundrum Of Chronic Respiratory Symptoms Zainab Kagen, MD1, Joel Ledbetter, MD2, Jennifer Hamm, MD3, Esther Wilson, MD4; 1University of Tennesee College of Medicine-Chattanooga, TN, 2University of Tennessee College of Medicine-Chattanooga, TN, 3 University of Tennesee College of Medicine-Chattanooga, 4University of Tennessee College of Medicine-Chattanooga. RATIONALE: This study describes the clinical findings and diagnoses associated with young children less than 24 months of age who presented to a pediatric pulmonologist with chronic cough and/or wheeze. We hypothesized the majority of these children would have a definitive diagnosis other than asthma. METHODS: The study was a retrospective chart review. Inclusion criteria included children less than 24 months of age referred to pediatric pulmonology at a medium-sized academic center between July 1, 2005 and June 30, 2011 for the evaluation of chronic cough and/or wheeze. Chronic cough defined as a daily cough that has persisted > 4 weeks. Data including age, gender, medications, results of diagnostic testing (i.e. swallow study), bronchoscopy, BAL results, cytopathology, and cultures were collected. RESULTS: While some children had multiple diagnoses, the most common diagnosis in this population was swallow dysfunction (51), followed by airway malacia (42), asthma (23), chronic wheezing (21), protracted bacterial bronchitis (19), slowly resolving pneumonia (10), viral-induced wheeze (10), viral-induced cough (8) and gastro-esophageal reflux (5). Other occasionally diagnosed conditions included pertussis, tracheo-esophageal fistula, transient hypogammaglobulinemia, and subglottic hemangioma. CONCLUSIONS: Allergy and asthma specialists must understand that swallowing dysfunction is a very common diagnosis in children less than 24 months of age presenting with chronic respiratory symptoms. In this review, only 23 out of 117 patients had a diagnosis of asthma. This analysis reveals the wide range of pediatric diagnoses associated with chronic respiratory symptoms, and emphasizes that wheezing children less than 24 months of age rarely have asthma.
619
Quantification Of The Wear-Off Effect Towards The End Of The Intravenous Immunoglobulin Infusion Interval: Pooled Data Analysis Mr. John-Philip Lawo1, Dr. Alphonse Hubsch2, Dr. Mikhail Rojavin, PhD3; 1CSL Behring GmbH, Marburg, Germany, 2CSL Behring AG, Berne, Switzerland, 3Clinical Research and Development, CSL Behring LLC, King of Prussia, PA. RATIONALE: Some patients with primary immunodeficiencies (PID) report increased frequencies of infections and/or fatigue at the end of their intravenous IgG (IVIG) dosing cycle. This study aimed to quantify the ‘‘wear-off’’ effect by analyzing efficacy endpoints throughout 3- or 4weekly IVIG dosing cycles. METHODS: The database included 132 patients (7482 data points) from Phase III trials of SandoglobulinÒ NF Liquid or PrivigenÒ. A binomial regression model for repeated measurements was used to compare infection probabilities during each week of the cycle. The compound symmetry correlation structure was used to account for within-subject correlation. To account for incubation periods of infections starting early after infusion, a 3-day shifted time interval analysis was performed. As this was a retrospective analysis for hypothesis generation, no adjustment of p-values due to multiplicity was performed. RESULTS: The probability of infection increased significantly in Week 4 compared to Week 1 of the 4-weekly cycle (ratio 1.55; p50.031). Although the same effect was observed for the 3-weekly cycle, the difference was not statistically significant (ratio 1.27; p50.362). With shifted time intervals, the number of days with infection increased moderately, but statistically significantly, at the end of both dosing cycles (3-weekly: ratio 1.13, p50.047; 4-weekly: ratio 1.13, p<0.001). No signs of wear-off were seen for days of hospitalization or absence from school/work. CONCLUSIONS: This analysis provides additional evidence for the existence of a ‘‘wear-off’’ effect in patients with PID. Possible ways of reducing the increased infection risk are shorter IVIG infusion intervals, increased IVIG dose and/or switch to subcutaneous therapy.
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