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doi:
10.1016/j.anai.2015.05.019.
No hypothalamic-pituitary-adrenal function effect with beclomethasone
dipropionate nasal aerosol, based on 24-hour serum cortisol in pediatric allergic
rhinitis.
Hampel FC Jr(1), Nayak NA(2), Segall N(3), Small CJ(4), Li J(4), Tantry SK(4).
Author information:
(1)Central Texas Health Research, New Braunfels, Texas. Electronic address:
fchampel@aol.com. (2)Sneeze, Wheeze, and Itch Associates, LLC, Normal, Illinois.
(3)Georgia Allergy and Respiratory, Atlanta, Georgia. (4)Teva Branded
Pharmaceutical Products R&D, Inc, Frazer, Pennsylvania.
BACKGROUND: Intranasal corticosteroids are the mainstay of allergic rhinitis (AR)
treatment. Their potential to suppress the hypothalamic-pituitary-adrenal axis
should be evaluated, especially after long-term daily use in children.
OBJECTIVE: To evaluate the effects of treatment with non-aqueous beclomethasone
dipropionate (BDP) nasal aerosol on hypothalamic-pituitary-adrenal axis function
in children with perennial AR.
METHODS: In this double-blinded, placebo-controlled, parallel-group study,
patients (6-11 years old) with perennial AR were randomized (2:1) to BDP nasal
aerosol at 80 g/day (n = 67) or placebo (n = 32). The primary end point was
change from baseline in 24-hour serum cortisol (SC) weighted mean for BDP nasal
aerosol and placebo after 6 weeks of treatment, which was analyzed in the
per-protocol population.
RESULTS: The per-protocol population included 97 patients (BDP nasal aerosol, n =
66; placebo, n = 31). Baseline geometric mean SC weighted mean values were
similar in the 80-g/day BDP nasal aerosol and placebo groups (5.97 and 6.47
g/dL, respectively). After 6 weeks' treatment, geometric mean values were 6.19
and 7.13 g/dL, respectively, with no decrease from baseline in either group.
Geometric mean SC ratio of BDP nasal aerosol at 80 g/day to placebo was 0.91
(95% confidence interval 0.81-1.03), indicating predefined noninferiority. SC
concentration-time profiles were similar for the placebo and 80-g/day BDP nasal
aerosol groups at baseline and week 6. BDP nasal aerosol at 80 g/day was
generally well tolerated.
CONCLUSION: In pediatric patients with perennial AR, 24-hour SC profiles were
comparable for BDP nasal aerosol and placebo, indicating that once-daily BDP
nasal aerosol treatment did not significantly affect
hypothalamic-pituitary-adrenal axis function.
TRIAL REGISTRATION: ClinicalTrials.gov; NCT01697956.
Copyright 2015 American College of Allergy, Asthma & Immunology. Published by
Elsevier Inc. All rights reserved.
PMID: 26250771
M.
Author information:
(1)'Sapienza' University of Rome, Department of Pediatrics , Rome , Italy.
Erratum in
Curr Med Res Opin. 2015;31(7):1449. Giulia, Montanari [corrected to
Montanari,
Giulia].
BACKGROUND: Intranasal steroids are recognized as an effective treatment for
allergic rhinitis (AR) although their effect on nasal patency has never been
evaluated with an objective instrument such as anterior rhinomanometry in
children. Moreover this effect has been widely assessed with total Nasal Symptom
Scores (NSS) including all symptoms of allergic rhinitis and not with scores
specifically focused on nasal obstruction such as the Nasal Obstruction Symptom
Evaluation score (NOSE).
MATERIALS AND METHODS: Sixty children (42 males and 18 female) aged 6-10 years,
affected by persistent AR, were randomized and divided in two groups of 30
children to be included in an unblinded trial: one group treated with intranasal
budesonide and isotonic nasal saline for 2 weeks and the other group treated only
with isotonic nasal saline for 2 weeks. Each child underwent rhinomanometry and
completed the NSS and the NOSE scores before and after treatment.
RESULTS: At the baseline nasal patency and NSS total score, NOSE total scores
were correlated (r=-0.29, p<0.001; r=-60, p<0.001). After 2 weeks of treatment
improvements in nasal patency, NSS and NOSE were seen ( NSS 4.13 1.38 vs 1.33
1.93, p<0.001; NOSE 34 17.97 vs 9 18.21, p<0.001; nasal patency -26.13
25.25 vs -11.83 11.31, p<0.001). Correlations were found between rhinitis
duration and nasal patency and NOSE (r=-0.84, p<0.001; r=0.43, p<0.01).
CONCLUSION: Intranasal budesonide is effective in increasing nasal patency in
children. Moreover the NOSE score was strongly correlated with nasal flow and,
hence, this score should be regarded as a valid and reliable instrument in
children.
PMID: 25629793
11. Curr Opin Otolaryngol Head Neck Surg. 2014 Dec;22(6):487-94. doi:
10.1097/MOO.0000000000000101.
Like asthma and atopic dermatitis, allergic rhinitis is an allergic disease, but
of the three, it is the only type I allergic disease. Allergic rhinitis includes
pollinosis, which is intractable and reduces quality of life (QOL) when it
becomes severe. A guideline is needed to understand allergic rhinitis and to use
this knowledge to develop a treatment plan. In Japan, the first guideline was
prepared after a symposium held by the Japanese Society of Allergology in 1993.
The current 7th edition was published in 2013, and is widely used today. To
incorporate evidence based medicine (EBM) introduced from abroad, the most recent
collection of evidence/literature was supplemented to the Practical Guideline for
the Management of Allergic Rhinitis in Japan 2013. The revised guideline includes
assessment of diagnosis/treatment and prescriptions for children and pregnant
women, for broad clinical applications. An evidence-based step-by-step strategy
for treatment is also described. In addition, the QOL concept and cost benefit
analyses are also addressed. Along with Allergic Rhinitis and its Impact of
Asthma (ARIA), this guideline is widely used for various clinical purposes, such
as measures for patients with sinusitis, childhood allergic rhinitis, oral
allergy syndrome, and anaphylaxis and for pregnant women. A Q&A section regarding
allergic rhinitis in Japan was added to the end of this guideline.
PMID: 25178177
5-16 years with moderate to severe intermittent or persistent AR who had never
used INCS. The patients were randomly divided into 2 groups; 1) those receiving
teaching about how to use INCS by an oral presentation without demonstration and
2) by animated cartoon-aided teaching. The performance of the children was
recorded after the initial training using a five-point checklist. If they were
unable to use the INCS correctly after the first teaching session, the same
instructions were repeated and a second assessment was performed.
RESULTS: A total of 80 patients, 40 each group, underwent randomization. The rate
of achieving competency for the patients after the first instruction using the
animated cartoon-aided teaching group was significantly higher than that for the
oral presentation group (57.5% VS 27.5%; P = 0.007). The cumulative success rate
for the second assessment of the animated cartoon-aided group was also
significantly higher than for those receiving only an oral presentation (95% VS
60%, P = 0.004).
CONCLUSION: With regard to mastering the correct method for INCS usage,
instruction using animated cartoon-aided teaching is better than oral
presentation without demonstration. However, the best method for teaching
patients how to use INCS is a combination of oral explanation and demonstration
by cartoon-aided teaching. The teaching should be repeated periodically to remind
patients of the correct method for INCS usage.
PMID: 25003731
(the diluent of active drug) two sprays (100L/spray) in each nostril three
times/day for 2 months. Nasal symptoms, including itching, sneezing, rhinorrhea,
and obstruction, were assessed at baseline and after treatment. Use of rescue
medication, such as cetirizine syrup, was also evaluated.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID NCT02130440.
RESULTS: Children treated with active drug achieved a significant reduction in
all nasal symptoms: itching (p=0.0001), sneezing (p=0.0009), rhinorrhea
(p=0.009), and obstruction (0.002) as well as antihistamine use (p=0.003).
Placebo did not affect nasal complaints and cetirizine use. The intergroup
analysis showed that active treatment was significantly superior to placebo about
reduction of AR symptoms and rescue medication use.
CONCLUSIONS: The present preliminary study firstly showed that intranasal
resveratrol plus carboxymethyl--glucan is capable of significantly improving
nasal symptoms in children with pollen-induced AR.
PMID: 24983742
22. NPJ Prim Care Respir Med. 2014 Jun 5;24:14012. doi: 10.1038/npjpcrm.2014.12.
Adolescent seasonal allergic rhinitis and the impact of health-care professional
training: cluster randomised controlled trial of a complex intervention in
primary care.
Hammersley VS(1), Elton RA(1), Walker S(1), Hansen CH(2), Sheikh A(3).
Author information:
(1)Allergy and Respiratory Research Group, Centre for Population Health Sciences,
The University of Edinburgh, Edinburgh, UK. (2)School of Molecular and Clinical
Medicine, The University of Edinburgh, Western General Hospital, Edinburgh, UK.
(3)1] Allergy and Respiratory Research Group, Centre for Population Health
25. Allergy. 2014 Jul;69(7):828-33. doi: 10.1111/all.12413. Epub 2014 May 12.
Is chronic rhinosinusitis related to allergic rhinitis in adults and children?
Applying epidemiological guidelines for causation.
Georgalas C(1), Vlastos I, Picavet V, van Drunen C, Garas G, Prokopakis E.
Author information:
(1)Department of Otorhinolaryngology, Academic Medical Centre, Amsterdam, the
Netherlands.
The relationship between allergic rhinitis and chronic rhinosinusitis has been
assessed in a number of observational and experimental studies. In this review,
we attempt their synthesis and evaluation using the modified Bradford Hill
guidelines for causation. Although there is no proof of causation, especially in
the pediatric literature, an evaluation of underlying allergies is recommended at
least as an initial measure of symptoms relief.
2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PMID: 24815699
specific IgE was observed in either groups. In the SLIT group, there was no
significant difference between children less than or more than 5 years old in
terms of clinical efficacy, onset of action, immunologic parameters, and safety.
No severe systemic AEs were reported.
CONCLUSION: SLIT is effective and well-tolerated in children with allergic
rhinitis 3-13 years old.
PMID: 24717951
Author information:
(1)GlaxoSmithKline, Research Triangle Park, North Carolina, USA.
Intranasal corticosteroids are the most effective medication class for
controlling allergic rhinitis (AR) symptoms. However, limited data are available
on their effects on basal hypothalamic-pituitary-adrenal (HPA) axis function in
children. This study was designed to determine the effect of 6-week triamcinolone
acetonide aqueous (TAA-AQ) nasal spray treatment on HPA axis function by
measuring 24-hour serum cortisol area under the curve (AUC(0-24h)) in children
with AR aged 2-11 years. This phase 4, multicenter, double-blind,
placebo-controlled, parallel-group study randomized children with AR to receive
TAA-AQ (110 g, 2-11 years old, or 220 g, 6-11 years old) or placebo. At preand posttreatment domiciled visits, 24-hour serum cortisol and reflective total
nasal symptom scores (rTNSSs) were assessed. Safety assessment included
treatment-emergent adverse events (TEAEs) at each visit and trough levels of
24-hour serum cortisol. A total of 140 subjects (mean age, 7.2 years; males, 59%)
were randomized; 66 from each group completed treatment. The ratio of TAA-AQ to
placebo for change from baseline in serum cortisol AUC(0-24h) was 0.966 (95%
confidence interval, 0.892-1.045). Reduction from baseline in mean rTNSS was
significantly greater in the TAA-AQ than in the placebo group (difference: least
square mean SE = -0.85 0.24; p = 0.0007). The safety profile was similar
(TEAEs, TAA-AQ, 27.5%; placebo, 25.4%), and so was the mean change in serum
cortisol trough level (TAA-AQ, -0.4 g/dL; placebo, -0.1 g/dL; p = 0.1818 for
treatment difference) from pre- to posttreatment. TAA-AQ was safe, well
tolerated, and not associated with clinically meaningful suppression of serum
cortisol AUC(0-24h) in children with AR. Clinical trial NCT01154153,
www.clinicaltrials.gov.
PMID: 24717794
31. BMC Complement Altern Med. 2014 Apr 6;14:128. doi: 10.1186/1472-6882-14-128.
A randomised multicentre trial of acupuncture in patients with seasonal allergic
rhinitis--trial intervention including physician and treatment characteristics.
Ortiz M(1), Witt CM, Binting S, Helmreich C, Hummelsberger J, Pfab F, Wullinger
M, Irnich D, Linde K, Niggemann B, Willich SN, Brinkhaus B.
Author information:
(1)Institute of Social Medicine, Epidemiology and Health Economics,
Charit-Universittsmedizin Berlin, Berlin, Germany. miriam.ortiz@charite.de.
BACKGROUND: In a large randomised trial in patients with seasonal allergic
rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue
medication. The aim of this paper is to describe the characteristics of the
trial's participating physicians and to describe the trial intervention in
accordance with the STRICTA (Standards for Reporting Interventions in Controlled
Trials of Acupuncture) guidelines, to make details of the trial intervention more
transparent to researchers and physicians.
METHODS: ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed,
randomised, controlled multicentre trial. 422 SAR patients were randomised to
semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham
acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in
order to evaluate their characteristics regarding their education about and
experience in providing acupuncture. During the trial, acupuncturists were asked
to diagnose all of their patients according to Chinese Medicine (CM) as a basis
for the semi-standardised, individualized intervention in the acupuncture group.
Every acupuncture point used in this trial had to be documented after each
session
RESULTS: Acupuncture was administered in outpatient clinics by 46 (mean age
4710 years; 24 female/ 22 male) conventionally-trained medical doctors (67%
with postgraduate specialization such as internal or family medicine) with
additional extensive acupuncture training (median 500 hours (1st quartile 350,
3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training
(350 hours)) and experience (mean 14 years in practice). The most reported
traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat
invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The
total number of needles used was higher in the acupuncture group compared to the
sham acupuncture group (15.7 2.5 vs. 10.0 1.6).
CONCLUSIONS: The trial interventions were provided by well educated and
experienced acupuncturists. The different number of needles in both intervention
groups could be possibly a reason for the better clinical effect in SAR patients.
For future trials it might be more appropriate to ensure that acupuncture and
sham acupuncture groups should each be treated by a similar number of needles.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT00610584.
PMCID: PMC3983860
PMID: 24708643 [PubMed - indexed for MEDLINE]
32. PLoS Med. 2014 Mar 11;11(3):e1001611. doi: 10.1371/journal.pmed.1001611.
eCollection 2014.
Active or passive exposure to tobacco smoking and allergic rhinitis, allergic
dermatitis, and food allergy in adults and children: a systematic review and
meta-analysis.
Saulyte J(1), Regueira C(1), Montes-Martnez A(1), Khudyakov P(2), Takkouche
B(1).
Author information:
(1)Department of Preventive Medicine, University of Santiago de Compostela,
Santiago de Compostela, Spain; Centro de Investigacin Biomdica en Red de
Epidemiologa y Salud Pblica (CIBER-ESP), Barcelona, Spain. (2)Departments of
Epidemiology and Biostatistics, Harvard School of Public Health, Boston,
Massachusetts, United States of America.
BACKGROUND: Allergic rhinitis, allergic dermatitis, and food allergy are
extremely common diseases, especially among children, and are frequently
associated to each other and to asthma. Smoking is a potential risk factor for
these conditions, but so far, results from individual studies have been
conflicting. The objective of this study was to examine the evidence for an
association between active smoking (AS) or passive exposure to secondhand smoke
and allergic conditions.
METHODS AND FINDINGS: We retrieved studies published in any language up to June
30th, 2013 by systematically searching Medline, Embase, the five regional
bibliographic databases of the World Health Organization, and ISI-Proceedings
databases, by manually examining the references of the original articles and
reviews retrieved, and by establishing personal contact with clinical
researchers. We included cohort, case-control, and cross-sectional studies
reporting odds ratio (OR) or relative risk (RR) estimates and confidence
intervals of smoking and allergic conditions, first among the general population
and then among children. We retrieved 97 studies on allergic rhinitis, 91 on
allergic dermatitis, and eight on food allergy published in 139 different
articles. When all studies were analyzed together (showing random effects model
results and pooled ORs expressed as RR), allergic rhinitis was not associated
with active smoking (pooled RR, 1.02 [95% CI 0.92-1.15]), but was associated with
passive smoking (pooled RR 1.10 [95% CI 1.06-1.15]). Allergic dermatitis was
associated with both active (pooled RR, 1.21 [95% CI 1.14-1.29]) and passive
smoking (pooled RR, 1.07 [95% CI 1.03-1.12]). In children and adolescent,
allergic rhinitis was associated with active (pooled RR, 1.40 (95% CI 1.24-1.59)
and passive smoking (pooled RR, 1.09 [95% CI 1.04-1.14]). Allergic dermatitis was
associated with active (pooled RR, 1.36 [95% CI 1.17-1.46]) and passive smoking
(pooled RR, 1.06 [95% CI 1.01-1.11]). Food allergy was associated with SHS (1.43
[1.12-1.83]) when cohort studies only were examined, but not when all studies
were combined. The findings are limited by the potential for confounding and bias
given that most of the individual studies used a cross-sectional design.
Furthermore, the studies showed a high degree of heterogeneity and the exposure
and outcome measures were assessed by self-report, which may increase the
potential for misclassification.
CONCLUSIONS: We observed very modest associations between smoking and some
allergic diseases among adults. Among children and adolescents, both active and
passive exposure to SHS were associated with a modest increased risk for allergic
diseases, and passive smoking was associated with an increased risk for food
allergy. Additional studies with detailed measurement of exposure and better case
definition are needed to further explore the role of smoking in allergic
diseases.
PMCID: PMC3949681
PMID: 24618794 [PubMed - indexed for MEDLINE]
33. J Laryngol Otol. 2014 Mar;128(3):242-8. doi: 10.1017/S002221511400036X. Epub
2014
Mar 11.
Quality of life assessment in patients with moderate to severe allergic rhinitis
treated with montelukast and/or intranasal steroids: a randomised, double-blind,
placebo-controlled study.
Goh BS(1), Ismail MI(2), Husain S(1).
Author information:
(1)Department of Otorhinolaryngology Head and Neck Surgery, Universiti Kebangsaan
Malaysia Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, Kuala Lumpur,
Malaysia. (2)Department of Otorhinolaryngology, Hospital Melaka, Malacca,
Malaysia.
OBJECTIVE: This study investigated improvements in quality of life associated
with eight weeks of montelukast and/or intranasal steroid treatment for moderate
to severe allergic rhinitis.
METHODS: A single-centre, prospective, randomised, double-blind,
placebo-controlled study was carried out. Assessments were made using the
Rhinoconjunctivitis Quality of Life Questionnaire and symptom scales.
RESULTS: A total of 128 patients (aged 13-51 years) were randomly assigned to one
of two groups. In the montelukast group, patients were treated with montelukast
tablets and fluticasone propionate nasal spray (n = 64). In the placebo group,
treatment comprised a placebo and fluticasone propionate. The results showed
significant improvements in symptom scores and quality of life scores for both
groups after one month and two months of treatment, compared with baseline
values; these improvements were significantly greater for the montelukast group
compared with the placebo group. The mean number of loratadine tablets taken by
each patient during the study period was only 0.73 for the montelukast group
compared with 9 for the placebo group.
CONCLUSION: The combination of montelukast tablets and fluticasone propionate
nasal spray improved symptom control and overall quality of life for moderate to
severe allergic rhinitis patients.
PMID: 24618303
35. J Allergy Clin Immunol Pract. 2013 May-Jun;1(3):214-26; quiz 227. doi:
10.1016/j.jaip.2013.03.012. Epub 2013 Apr 29.
Current and future directions in pediatric allergic rhinitis.
Gentile D(1), Bartholow A(1), Valovirta E(2), Scadding G(3), Skoner D(4).
Author information:
(1)Division of Allergy, Asthma and Immunology, Department of Medicine, Allegheny
General Hospital, Pittsburgh, Pa. (2)Turku Allergy Center, Turku, Finland. (3)The
Royal National Throat, Nose and Ear Hospital, London, United Kingdom. (4)Division
of Allergy, Asthma and Immunology, Department of Medicine, Allegheny General
Hospital, Pittsburgh, Pa. Electronic address: dskoner@wpahs.org.
BACKGROUND: Allergic rhinitis (AR) is a common pediatric problem that
significantly affects sleep, learning, performance, and quality of life. In
addition, it is associated with significant comorbidities and complications.
OBJECTIVE: The aim was to provide an update on the epidemiology, comorbidities,
pathophysiology, current treatment, and future direction of pediatric AR.
METHODS: Literature reviews in each of these areas were conducted, and the
results were incorporated.
RESULTS: The prevalence of AR is increasing in the pediatric population and is
associated with significant morbidity, comorbidities, and complications. The
mainstay of current treatment strategies includes allergen avoidance,
pharmacotherapy, and allergen specific immunotherapy.
CONCLUSIONS: In the future, diagnosis will be improved by microarrayed
recombinant allergen testing and therapy will be expanded to include emerging
treatments such as sublingual immunotherapy and combination products.
Copyright 2013 American Academy of Allergy, Asthma & Immunology. Published by
Elsevier Inc. All rights reserved.
PMID: 24565478
36. Int Forum Allergy Rhinol. 2014 Feb;4(2):110-6. doi: 10.1002/alr.21246. Epub
2013
Nov 4.
The role of secondhand smoke in allergic rhinitis: a systematic review.
Hur K(1), Liang J, Lin SY.
Author information:
(1)Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins University,
Baltimore, MD.
BACKGROUND: The objective of this work was to systematically review existing
literature on the association between allergic rhinitis (AR) and secondhand
smoking (SHS) in children and adults.
METHODS: We performed a literature search encompassing the last 25 years in
PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL),
Cochrane CENTRAL, Web of Science, Scopus, and EMBASE. Inclusion criteria included
English language papers containing original human data with greater than 6
subjects. Data was systematically collected on study design, patient
demographics, clinical characteristics/outcomes, and level-of-evidence (Oxford
Center of Evidence-Based Medicine). Quality assessment of the studies was
performed using the Newcastle-Ottawa scale. Two investigators independently
reviewed all manuscripts.
RESULTS: The initial search yielded 590 abstracts, of which 40 articles were
included. 12 (37.5%) of the 32 articles studying children and 5 (62.5%) of the 8
articles studying adults showed a statistically significant association between
AR and SHS. One article was a prospective cohort study (Level 2b) and all other
articles were case-control studies (Level 3b). For characterizing AR, 10 (25%)
studies included skin-prick testing and 5 (12.5%) used in vitro testing. For
determining presence of SHS, 39 (97.5%) of the studies used questionnaires and 1
article used a cotinine/creatinine ratio.
CONCLUSION: This review demonstrated a majority of adult studies vs a minority of
children studies found a significant association between AR and SHS. However, the
percent difference between age groups was not statistically significant. Further
higher-quality studies with validated methods for diagnosing AR and quantifying
SHS exposure should be performed to better evaluate the relationship between AR
and SHS in adults and children.
2013 ARS-AAOA, LLC.
PMID: 24493468
41. J Pharm Sci. 2013 Dec;102(12):4213-29. doi: 10.1002/jps.23720. Epub 2013 Nov
1.
An overview of the pediatric medications for the symptomatic treatment of
allergic rhinitis, cough, and cold.
Fan Y(1), Ji P, Leonard-Segal A, Sahajwalla CG.
Author information:
(1)Division of Clinical Pharmacology II, Office of Clinical Pharmacology, U.S.
Food and Drug Administration, Silver Spring, Maryland, 20993.
Upper respiratory infections and allergic rhinitis are common diseases in
children. In recent years, U.S. Food and Drug Administration has been promoting
pediatric drug development with marketing exclusivity incentives and
requirements. The assessment of clinical pharmacology, efficacy, and safety data
has facilitated pediatric drug development and provided appropriate labeling for
pediatric use. Regulatory decision making involves multiple evaluation processes,
including drug exposure comparison between adult and pediatric population,
formulation bridging, dose selection, and evaluation of efficacy and safety in
pediatric patients. This article reviews the pediatric drugs indicated for cough,
cold, and allergic rhinitis, focusing on the utility of clinical pharmacology,
safety, and efficacy data in determining the pediatric dosing regimen and the
approaches taken for regulatory decision making.
2013 Wiley Periodicals, Inc. and the American Pharmacists Association.
PMID: 24185951
Author information:
(1)Phase V Technologies, Inc., Wellesley Hills, Massachusetts, USA.
Allergic rhinitis (AR) affects 7.8% of U.S. adults and 10-30% of the population
worldwide. AR symptoms (rhinorrhea, congestion, sneezing, nasal/ocular pruritus,
and postnasal drainage) significantly impact sleep and reduce cognitive and
emotional functioning affecting work and school productivity. Although effective,
intranasal corticoid (INS) steroid delivery systems are often associated with
adverse sensory attributes, affecting patient adherence and reducing efficacy.
Patient satisfaction with treatment characteristics predicts adherence levels
that can better inform treatment decisions. This study was designed to evaluate
psychometric evidence for the self-administered Allergic Rhinitis Treatment
Satisfaction and Preference (ARTSP) scale as a patient-reported outcomes measure
for use in clinical research. Analytic methods included qualitative analysis of
patient focus groups and psychometric analysis of scale data collected from 185
AR subjects enrolled in a randomized, 2-week, crossover, comparative U.S.
clinical trial. Qualitative analysis conceptually supported nine treatment
satisfaction subscales. Reliability by Cronbach alpha met accepted standards.
Evidence was found for construct validity using structural equation modeling,
criterion validity from correlation patterns between treatment satisfaction and
health-related quality of life scales, and discriminant validity analysis based
on AR symptom-defined groups. Responsiveness was shown by significant change in
treatment satisfaction subscales among AR symptom change groups. Scores on
treatment preference items discriminated between the aqueous and aerosol INS
formulations. The ARTSP scale is a conceptually sound, reliable, valid, and
responsive measure of patient evaluations of alternative therapies, providing
detailed information about treatment characteristics that are likely to influence
adherence levels and subsequent AR clinical control.
PMID: 24079817
total nasal symptom score by 5.7 as compared to azelastine (4.4; P < 0.001),
fluticasone propionate (5.1; P < 0.001) and placebo (3.0; P < 0.001). The
findings were supported by secondary assessments of scores of specific nasal and
ocular symptoms. Pharmacokinetic studies have revealed no drug-drug interactions
but a discrete increase in bioavailability of fluticasone propionate which was
considered clinically unimportant. Further efficacy and quality-of-life studies
of combination products of nasal antihistamines and corticosteroids are needed,
especially, in primary care settings and in children before fixed combination
treatment can be considered first line therapy in allergic rhinitis. Fixed
combination treatment of azelastine and fluticasone propionate may offer
additional benefit to selected populations of adolescents and adults with
moderate-to-severe symptoms.
PMID: 23862774
p < 0.01) groups. The flow rate test results indicated significant improvements
in the MFM group (t = 2.27, p < 0.05).
CONCLUSION: Following the 4-week therapy, MFM provided greater improvement
compared to FP for symptoms of childhood perennial-allergic rhinitis. Based on
their TSSs, the MFM group experienced more effective relief of nasal symptoms,
whereas the FP group experienced more effective relief of non-nasal symptoms.
Copyright 2013. Published by Elsevier B.V.
PMID: 23597528
congestion, but the combination has not been fully studied. This study was
designed to assess the efficacy of the combination of MFNS and OXY for the relief
of seasonal allergic rhinitis (SAR) symptoms.
METHODS: This phase 2 controlled clinical trial randomized adolescent and adult
subjects (12 years; 2-year SAR) to MFNS q.d. (200 g) + 3 sprays/nostril of OXY
0.05% (MFNS + OXY3); MFNS q.d. + 1 spray/nostril of OXY (MFNS + OXY1); MFNS q.d.;
OXY b.i.d.; or placebo for 15 days, with 1-week follow-up. Coprimary end points
were change from baseline in morning/evening (A.M./P.M.) instantaneous (NOW)
total nasal symptom score (TNSS) over days 1-15 and AUC (AUC[0-4 hr]) change from
baseline in day 1 congestion.
RESULTS: In 705 subjects, both combinations reduced A.M./P.M. NOW TNSS over days
1-15 significantly more than OXY b.i.d. or placebo (p 0.002). Mean standardized
AUC(0-4 hr) day 1 congestion change from baseline was significantly greater in
combination and OXY b.i.d. groups (MFNS + OXY3, -0.92; MFNS + OXY1, -0.80; OXY
b.i.d., -1.06) versus placebo (-0.57) and MFNS q.d. (-0.63). Combinations and
MFNS q.d. were significantly effective for A.M./P.M. NOW TNSS over each weekly
period; OXY b.i.d. was superior to placebo in week 1. Adverse events (AEs) were
few and similar across treatments; one MFNS q.d. and one placebo subject
experienced a serious AE, with neither considered treatment related.
CONCLUSION: Combining MFNS with OXY relieves SAR symptoms, including congestion,
with faster onset of action than MFNS q.d. and better sustained efficacy than OXY
b.i.d.
PMID: 23562197
SLIT, superiority of one mode of administration over the other could not be
consistently demonstrated through indirect comparison, and further research is
needed to establish the comparative effectiveness of SCIT versus SLIT.
Copyright 2013 American Academy of Allergy, Asthma & Immunology. Published by
Mosby, Inc. All rights reserved.
PMID: 23557834
with PER.
METHODS: A multicenter, randomized, double-blind, placebo-controlled study was
carried out worldwide. Patients between 6 and 11 yr with a diagnosis of PER
according to ARIA criteria were randomized to receive either rupatadine oral
solution (1 mg/ml) or placebo over 6 wk. The primary efficacy end-point was the
change from baseline of the total nasal symptoms score (T4SS) after 4 wk of
treatment.
RESULTS: A total of 360 patients were randomized to rupatadine (n = 180) or
placebo (n = 180) treatment. Rupatadine showed statistically significant
differences vs. placebo for the T4SS reduction both at 4 (-2.5 1.9 vs.
-3.1 2.1; p = 0.018) and 6 wk (-2.7 1.9 vs. -3.3 2.1; p = 0.048).
Rupatadine also showed a statistically better improvement in the children's
quality of life compared with placebo. Adverse reactions were rare and
non-serious in both treatment groups. No QTc or laboratory test abnormalities
were reported.
CONCLUSIONS: Rupatadine oral solution (1 mg/ml) was significantly more effective
than placebo in reducing nasal symptoms at 4 and 6 wk and was well tolerated
overall. This is the first large clinical report on the efficacy of an H1
receptor antagonist in children with PER in both symptoms and quality of life.
2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.
PMID: 23384091
68. Int Forum Allergy Rhinol. 2013 Jun;3(6):504-9. doi: 10.1002/alr.21123. Epub
2013
Jan 10.
The association between allergic rhinitis and sleep-disordered breathing in
children: a systematic review.
Lin SY(1), Melvin TA, Boss EF, Ishman SL.
Author information:
(1)Johns Hopkins Department of Otolaryngology-Head and Neck Surgery, Baltimore,
MD 21287, USA. slin@jhmi.edu
BACKGROUND: The objective of this work was to systematically review existing
literature on the association between allergic rhinitis (AR) and sleep-disordered
breathing (SDB) in children.
METHODS: We performed a literature search encompassing the last 25 years in
PubMed, EMBASE, and Cochrane CENTRAL. Inclusion criteria included
English-language papers containing original human data, number of subjects 7,
and age <18 years old. Data was systematically collected on study design, patient
demographics, clinical characteristics/outcomes, and level-of-evidence. Two
investigators independently reviewed all articles.
RESULTS: The initial search yielded 433 abstracts, of which 18 articles were
included. Twelve (67%) of the 18 articles showed a statistically significant
association between AR and SDB. All articles were either case-series or
case-control studies. Based on the Newcastle-Ottawa scale, the quality of the
articles was determined to be fair to good. For characterizing AR, 7 (39%)
studies included skin-prick testing and/or in vitro testing. For determining
presence of SDB, 7 (39%) of the studies used polysomnographic data, of which 1
study incorporated data from a home polysomnogram. Habitual snoring was the most
common form of SDB studied, in 10 (56%) of the articles. Obstructive sleep apnea
was studied in 6 (33%) articles.
CONCLUSION: Although the majority of the studies included in this review showed a
significant association between AR and SDB, all of the studies were evidence
level 3b and 4, for an overall grade of B- evidence (Oxford Evidence-Based
Medicine Center). Further higher-quality studies should be performed in the
future to better evaluate the relationship between AR and SDB in children.
daily for 10 days and then swapped to the others. The washout period was at least
5 days. Primary outcomes were nasal symptoms, mucociliary clearance time, and
nasal patency. Outcomes were compared between baseline and posttreatment and also
between various kinds of solution. Secondary outcomes were patients' preference
and adverse events.
RESULTS: Thirty-six subjects entered the study, and there were no dropouts.
Overall nasal symptom was significantly improved from baseline (P = 0.03) only by
buffered solution with mild alkalinity. Sneezing was significantly improved from
baseline (P = 0.04) only by buffered solution with alkalinity. No other
significant improvements were achieved by any solution. When comparing between
the three nasal irrigations, there were no differences in all parameters. The
patients significantly preferred the buffered solution with mild alkalinity (P =
0.02).
CONCLUSIONS: Buffered isotonic saline with some degree of alkalinity may improve
nasal symptoms. Isotonic saline irrigations, regardless of alkalinity, may not
improve mucociliary function and nasal patency. Buffered isotonic saline with
mild alkalinity is the most preferred.
Copyright 2012 The American Laryngological, Rhinological, and Otological
Society, Inc.
PMID: 23070939