Use Of Intranasal Corticosteroids Research Articles

Risks Associated with the Use of Intranasal Corticosteroids: An Analysis of Adverse Reactions Reported to EudraVigilance.

Background: Intranasal corticosteroids (INCS) are used for several conditions, including allergic rhinitis and sinusitis. Consequently, their safety profile needs continuous monitoring. This study aimed to analyse the adverse drug reactions (ADRs) of the INCS with market authorisation in Europe. Methods: A retrospective analysis of the ADR data from EudraVigilance in the period between the 1 January 2011 and 12 June 2023 was performed, with 2641 reports selected for analysis. ADRs were categorised by seriousness and evolution, with a focus on the most prevalent ADRs and their alignment with the Summary of Product Characteristics (SmPC). Results: The 18-64 age group, particularly females, was most affected. Mometasone was the most reported INCS, with predominantly non-serious ADRs, evolving towards resolution, which often were not listed in the SmPC. From the reported ADRs that were not described in the SmPC of the INCS studied, "Anosmia" and "Ageusia" were highlighted. Regarding the ADRs described in the SmPC, the most frequently reported were "Epistaxis" and "Headache". The ADRs belonging to the Designated Medical Event list were also analysed, with "Angioedema" as the most reported ADR, which was mainly associated with budesonide. Conclusions: These findings underscore the importance of continuous INCS monitoring to mitigate ADRs and safeguard public health. Further research is warranted to explore potential novel signs for safety arising from previously unreported ADRs.

Focused allergic rhinitis practice parameter for Canada.

Allergic rhinitis (AR) is a prevalent disease in Canada that affects both children and adults. Several guidelines for the management of AR have been published by professional allergy societies worldwide. However, there are regional differences in the clinical management of AR, and regulatory approval of some AR pharmacotherapies varies among countries. Thus, six research questions specific to the treatment of AR in Canada were identified for this focused practice parameter. Reviews of the literature published since 2016 were conducted to obtain evidence-based support for the responses of the Work Group to each research question. In response to research question 1 "In patients with symptoms indicative of AR, is serum-specific IgE sufficient to identify candidates for immunotherapy or is a skin prick test mandatory?" the Work Group concluded that either sIgE testing or skin prick test are acceptable for diagnosing AR and guiding immunotherapy. In response to research question 2 "When taking into account the preferences of the patient and the prescriber (stakeholder engagement) should second-generation oral antihistamine (OAH) or intranasal corticosteroid (INCS) be first line?" the Work Group concluded that existing guidelines generally agree on the use of INCS as a first-line therapy used for AR, however, patient and provider preferences and considerations can easily shift the first choice to a second-generation OAH. In response to research question 3 "Is a combination intranasal antihistamine (INAH)/INCS formulation superior to INCS plus OAH? Do they become equivalent after prolonged use?" the Work Group concluded that that the combination INAH/INCS is superior to an INCS plus OAH. However, there was insufficient evidence to answer the second question. In response to research question 4 "Do leukotriene receptor antagonists (LTRA) have a greater benefit than OAH in AR for some symptoms to justify a therapeutic trial in those who cannot tolerate INCS?" the Work Group concluded that LTRAs have inferior, or at best equivalent, daytime or overall symptom control compared with OAH, but LTRAs may improve nighttime symptom control and provide benefits in patients with AR and concomitant asthma. In response to research question 5 "Should sublingual immunotherapy (SLIT) tablets be considered first-line immunotherapeutic options over subcutaneous immunotherapy (SCIT) based on the evidence of efficacy?" the Work Group concluded that the choice of SLIT or SCIT cannot be made on efficacy alone, and differences in other factors outweigh any differences in efficacy. In response to research question 6 "Based on efficacy data, should ALL patients seen by an allergist be offered SLIT or SCIT as a treatment option?" the Work Group concluded that the efficacy data suggests that SLIT or SCIT should be used broadly in patients with AR, but other clinical concerns also need to be taken into consideration.

Intranasal corticosteroid users in The Netherlands: A drug utilization study

BackgroundTo improve (patient-tailored) instructions for intranasal corticosteroid (INC) administration we need to gain insight into specific characteristics of INC-users and co-medication use. ObjectiveWe examined INC drug prescriptions, obtained from the Dutch InterAction Database, to get insight into the prevalence- and incidence rates, INC-use in previous years and co-medication. MethodsWe retrospectively examined INC prescriptions between January 1, 2015, and December 31, 2019. Prevalence- and incidence rates were stratified by age and gender. The use of INCs in previous years and co-medication were analyzed. ResultsThe total number of INC prescriptions in 2019 was 172,563, dispensed to 75,048 individuals. The prevalence and incidence of INC users were 68.9 and 25.6 per 1,000 individuals respectively in 2019. INCs were used by all age-groups. More than half of the users in 2019 did not receive a prescription in 2018, almost a quarter received a prescription in five consecutive years. 28% of the users used an INC in combination with an inhaler, 29% with a systemic antihistamine, 9% with ocular medication and 1% with an intranasal antihistamine. Several corticosteroids-containing drugs are used in combination with INCs by 2 to 16%. ConclusionThis study gives insights into opportunities for patient-tailored instructions. INCs are used by various age groups and by new or intermittent users and continuous users. Based on this, patient-tailored instructions can be developed and then it needs to be studied if these instructions affect treatment adherence and efficacy. The insights gained about co-medication provide opportunities for improved evaluation of the INC administration technique. Altogether, these suggestions might lead to a more patient-tailored approach which might lead to improved treatment with intranasal corticosteroids.

General practitioner and patient perspectives on intranasal corticosteroids for allergic rhinitis: Treatment duration and obstacles to adherence, findings from a recent survey

Background and objectiveCurrently, there are no guideline recommendations for the duration of intranasal corticosteroid (INCS) treatment for allergic rhinitis (AR). We aimed to catalogue real-world AR-INCS prescription patterns. Materials and methodsThis multicenter, non-interventional, cross-sectional study used online general practitioner (GP) and patient surveys from 4 countries. Eligible GPs had 3–35 years of practical experience, regularly prescribed INCSs for AR treatment, and had managed ≥5 patients with AR per month according to Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines in the previous year. Eligible patients with AR were non-pregnant females or males, aged 18–65 years, previous AR-INCS users (≥12 months), and receiving GP-prescribed AR therapy. Survey participants were from countries with 15–50% AR prevalence and mostly prescription-only INCS use of ≥100 million units annually (Brazil, Mexico, Spain, Thailand). GP surveys and GP-completed patient record forms (PRFs) gathered AR-care and INCS-use data over 10 months; each GP completed patient record forms (PRFs) for 3 patients with AR under their care. The patient survey reflected actual AR-INCS experience, treatment duration, and adherence factors from patient perspectives. The target sample size was 75 GPs, 75 patients, and ≥30 respondents per country. ResultsFrom 900 GP-PRFs, the mean GP-recommended AR-INCS durations reported were 8.4 (Brazil), 8.3 (Mexico), 5.4 (Spain), and 6.4 (Thailand) weeks. From 300 patient surveys, mean reported INCS recommended durations were 6.4 (Brazil), 5.1 (Mexico), 4.0 (Spain), and 4.9 (Thailand) weeks; reported actual use durations were 6.2, 4.8, 3.6, and 6.4 weeks, respectively. The most frequent GP-PRF-reported factors influencing AR-INCS treatment duration were symptom severity (76–85%), symptom recurrence (49–73%), and existing comorbidities (33–57%). The most frequent GP-PRF-reported obstacles to adherence included forgetting to take medication regularly (54–100%), subsiding symptoms (42–91%), and being unable to continue activities (33–51%). Subsiding symptoms (36–53%) and reaching the prescription duration end (20–51%) were most frequent obstacles reported by the patient survey. Patients from all surveyed countries indicated that they visited the GP, a different physician, or a pharmacy for assistance with symptom recurrence; some patients also self-medicated. ConclusionsReal-world AR-INCS prescription durations vary between countries and actual use tends to be shorter than prescribed. Understanding underlying factors may support appropriate AR-INCS use. The study was not powered to statistically compare intercountry differences; hence, comparisons have not been drawn, and the small sample may not reflect a complete picture of clinical practice and patients with AR in each country.

Early Endoscopic Sinus Surgery after Medical Failure Improves Postoperative Inflammation Control in Chronic Rhinosinusitis without Nasal Polyps

Objective: To determine the association between time to elective endoscopic sinus surgery (ESS) and postoperative medication consumption and cost during a two-year follow up in patients with chronic rhinosinusitis without nasal polyps (CRSsNP). Materials and Methods: The authors reviewed medical records of patients treated with ESS after medical failure between 2009 and 2020 at the Songklanagarind Hospital. The patients were divided into three groups, early surgery at less than one year, mid-surgery at one to five years, and late surgery at more than five years. The number of postoperative visits, CRS-related medications, and costs were compared among the groups. Multivariate analysis was performed to estimate the relationships between the independent factors. Results: Sixty-nine patients were enrolled in the present study with 30.4% who underwent early surgery, 52.2% who were treated with mid-surgery, and 17.4% who underwent late surgery. The number of 2-year postoperative intranasal corticosteroids (INCS) used, and CRS-related medication costs compared with the time to surgery were significantly different. The higher frequency of prescriptions for INCS use and CRS-related medication costs were significantly different between the groups. Conclusion: Time to sinus surgery was associated with the 2-year postoperative INCS use and CRS-related medication costs. Early surgery, after the appropriate medical treatment failed, was a better prognostic predictor for reduced INCS use and medication costs after surgery and could be an effective option for improving postoperative inflammation control and managing CRS.

Study protocol: the biologics in severe chronic rhinosinusitis with nasal polyps survey

IntroductionChronic rhinosinusitis with nasal polyps (CRSwNP) is a frequent condition affecting approximately 2% of the population. Medical treatment consists long-term use of intranasal corticosteroids and short-term use of oral corticosteroids,...

Intranasal antihistamines and corticosteroids in allergic rhinitis: A systematic review and meta-analysis

BackgroundThere is insufficient systematised evidence on the effectiveness of individual intranasal medications in allergic rhinitis (AR). ObjectiveTo perform a systematic review to compare the efficacy of individual intranasal corticosteroids and antihistamines against placebo in improving the nasal and ocular symptoms and the rhinoconjunctivitis-related quality-of-life of patients with perennial or seasonal AR. MethodsWe searched four electronic bibliographic databases and three clinical trials databases for randomised controlled trials (i) assessing adult patients with seasonal or perennial AR and (ii) comparing the use of intranasal corticosteroids or antihistamines versus placebo. Assessed outcomes included the Total Nasal Symptom Score (TNSS), the Total Ocular Symptom Score (TOSS) and the Rhinoconjunctivitis Quality-of-Life Questionnaire (RQLQ). We performed random-effects meta-analyses of mean differences for each medication and outcome. We assessed evidence certainty using the GRADE approach. ResultsWe included 151 primary studies, most of which assessed patients with seasonal AR and displayed unclear or high risk of bias. Both in perennial and seasonal AR, most assessed treatments were more effective than placebo. In seasonal AR, azelastine-fluticasone, fluticasone furoate and fluticasone propionate were the medications with the highest probability of resulting in moderate or large improvements in the TNSS and RQLQ. Azelastine-fluticasone displayed the highest probability of resulting in moderate or large improvements of TOSS. Overall, evidence certainty was considered “high” in 6/46 analyses, “moderate” in 23/46 analyses, and “low”/“very low” in 17/46 analyses. ConclusionMost intranasal medications are effective in improving rhinitis symptoms and quality-of-life. However, there are relevant differences in the associated evidence certainty.

The updated role of budesonide in managing children and adolescents with allergic rhinitis.

Allergic rhinitis (AR) is a prevalent disease in childhood and adolescence. A type 2 inflammation characterizes AR and, mainly, sustains nasal obstruction. Budesonide aqueous nasal spray (BANS) is an intranasal corticosteroid (INCS) available since the early 1980s. BANS is indicated for treating allergic rhinitis. There is evidence about its efficacy in treating children and adolescents with seasonal and perennial AR. In addition, BANS is safe with negligible local and systemic side effects. Recent guidelines for patients with AR recommend the use of INCS as first line in many situations. In particular, AR patients (and their parents) may assess the perception of symptoms' severity using the Visual Analog Scale (VAS). A score ≥5/10 means uncontrolled symptoms and requires adequate treatment. BANS could appropriately be used in patients with uncontrolled symptoms and/or moderate/severe nasal obstruction. In conclusion, BANS represents a valuable option in managing children and adolescents with AR.

Modern approaches to rational combination pharmacotherapy of allergic rhinitis

Allergic rhinitis (AR) can significantly reduce the quality of life of patients leading to increased fatigue, mood changes, cognitive impairment, and depression. In clinical practice, insufficient effectiveness of initial AR monotherapy is often noted, and a significant proportion of patients referring for medical care have moderate-severe AR. In this regard, the issues of optimization of combined pharmacological treatment of AR are becoming more and more urgent. This paper provides analysis of the opportunities of combined pharmacotherapy within the framework of current management strategy of AR. Based on the results of some studies and known pharmacological properties of medications it is being discussed the advantages of combined use of intranasal corticosteroids and leukotriene receptor antagonists, in particular mometasone furoate and montelukast, in the therapy of AR, including such comorbidities as bronchial asthma, chronic polyposis rhinosinusitis and pharyngeal tonsil hyperplasia. Some aspects of combination therapy with montelukast and second-generation systemic antihistamines as an alternative approach in case of inability to take intranasal corticosteroids, including the reasonability of using a fixed combination of montelukast and levocetirizine, are analyzed from the perspective of rational pharmacotherapy. The problem of interchangeability of brand-name and generic drugs for the treatment of AR is discussed, considering the almost complete absence of studies of their therapeutic equivalence.

Intranasal antihistamines and corticosteroids in the treatment of allergic rhinitis: a systematic review and meta-analysis protocol

IntroductionIntranasal antihistamines and corticosteroids are some of the most frequently used drug classes in the treatment of allergic rhinitis. However, there is uncertainty as to whether effectiveness differences may exist...

Using Intranasal Corticosteroids and Oral Antihistamines to Treat Allergic Rhinitis: A Comparison of The Mean Total Nasal Symptom Score

Background: Allergic rhinitis (AR) is a global public health issue. The disease is a leading cause of death and disabilities globally. Objective: To compare the mean total nasal symptom score using intranasal corticosteroids with oral anti-histamine in management of allergic rhinitis. Study Design: Randomized controlled trial. Settings: Department of ENT, Shalamar Medical and Dental College/ Shalamar Hospital, Lahore Pakistan. Duration: 1st January 2023 to 30 June 2023. Methods: 100 cases equally divided in two groups A&B, Intranasal corticosteroids were administered in Group A and oral anti-histamine in Group B cases, The final evaluation was done after 4 weeks of treatment. Results: Comparison of mean total nasal symptom score using intranasal corticosteroids with oral anti-histamine in management of allergic rhinitis shows that 1.51 ± 0.37 score in Group-A and 1.27 ± 0.11 score in Group-B, (p-value < 0.05). Conclusion: We found that the use of intranasal corticosteroids resulted in a substantially reduced mean total nasal symptom score compared to the use of oral anti-histamine in the treatment of allergic rhinitis.

COVID-19 and Its Impact on Common Diseases in the Allergy Clinics

Coronavirus disease 2019 (COVID-19) is a highly contagious viral disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It has various effects on asthma, allergic rhinitis, atopic dermatitis and urticaria and may change the course of the disease depending on the severity of the infection and control status of the disease. Conversely these diseases may also impact the course of COVID-19. Chronic urticaria and atopic dermatitis patients may have COVID-19-induced disease exacerbations and biological treatments reduce the risk of exacerbations. Poor asthma control is linked to severe COVID-19 while allergic asthma is associated with lower risk of death and a lower rate of hospitalization due to COVID-19 compared to non-allergic asthma. The use of intranasal corticosteroids is associated with lower rates of hospitalization due to COVID-19 in allergic rhinitis patients, whereas the effect of inhaled corticosteroids is confounded by asthma severity. These observations reinforce the importance of keeping allergic diseases under control during pandemics. The use of biologicals during COVID-19 is generally regarded as safe, but more evidence is needed. The pandemic substantially changed the management of allergic disorders such as home implementation of various biologicals, allergen immunotherapy, food introduction and increased use of telemedicine and even home management of anaphylaxis to reduce emergency department burden and reduce risk of infection. Physicians need to be aware of the potential impact of COVID-19 on allergic diseases and educate their patients on the importance of continuing prescribed medications and adhering to their treatment plans to maintain optimal control of their disease.

The Effect of Intranasal Steroid on Nasal Mucociliary Clearance in Allergic Rhinitis

Intranasal glucocorticosteroids are the most effective treatment for allergic rhinitis and are recommended as first-line therapy for patients with moderate to severe Allergic Rhinitis, particularly when nasal congestion is the prominent symptom. The use of intranasal corticosteroids showed to affect the mucociliary action by decreasing the prolonged mucociliary clearance time and increasing the mucociliary clearance rate. Keywords: AR- Allergic Rhinitis, INCS- Intranasal corticosteroid, NMC- Nasomucociliary clearance, MCT- Mucociliary Clearance Time, MCR- Mucociliary clearance rate, OAH- Oral antihistamine

Evaluation of Chronic Rhinosinusitis Symptoms' Severity Following COVID-19 Infection: A Retrospective Analysis.

Objectives This study aims to compare the severity of chronic rhinosinusitis (CRS) symptoms pre- and post-COVID-19infection and estimate the impact of the COVID-19 pandemic on the use of intranasal corticosteroids (ICS) among adult CRS patients. Methods This was an observational retrospective cohort study conducted at King Abdulaziz University Hospital, Riyadh, Saudi Arabia, between July 2022 and October 2022. Adult CRS patients with sino-nasal outcomes test-22 (SNOT-22) scores documented prior to March 2020, marking the occurrence of Saudi Arabia's initial reported case of COVID-19, were requested to complete the SNOT-22 questionnaire following COVID-19 infection.A comparison was subsequently made between the two scores obtained. Results The study enrolled a total of 33 patients, with 16 assigned to the control group and 17 with a history of COVID-19 infection. The mean age of the patients was 43 years, and the majority (52%) were males. Statistical analysis did not reveal any statistically significant differences in the total SNOT-22 scores or domain-level scores between the two groups. Furthermore, the use of ICS during the COVID-19 pandemic did not show any significant associations, except for patients with asthma, where 80% of them used ICS during the pandemic (p=0.0073). Conclusion There was no statistically significant disparity observed in the SNOT-22 scores between patients who tested positive for COVID-19 and those who did not.The use of corticosteroids during the COVID-19 pandemic was found to be more prevalent in this study compared to previous studies conducted before the pandemic, particularly among patients with asthma. The use of ICS during the pandemic was not associated with the presence of polyps, functional endoscopic sinus surgery (FESS), allergic rhinitis, or eczema.

Evaluation of the clinical features and laboratory data of patients with severe asthma classified as super-responder or non super-responder to omalizumab treatment: a single-center real-life study

Introduction Omalizumab is used for the treatment of severe allergic asthma. Objective The aim of this study was to evaluate the clinical features and laboratory data of patients with severe allergic asthma classified as super-responder or non super-responder to omalizumab. Methods Comparisons were made of the laboratory data and clinical features of patients with severe allergic asthma. Patients who had no asthma exacerbation, no oral corticosteroid (OCS) use, asthma control test (ACT) score >20 and forced expiratory volume in 1 s (FEV1) >80% were considered super-responder after omalizumab. Results A total of 90 patients were included in the study, comprising 19 (21.1%) males. The age at onset of asthma, allergic rhinitis rate, number of endoscopic sinus surgeries (ESS), intranasal corticosteroid (INS) use, baseline FEV 1 (%) and ACT score were significantly higher in the omalizumab super-responder group (p = 0.013, p = 0.015, p = 0.002, p = 0.001, p = 0.001 and p < 0.001, respectively). The duration of asthma, rate of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), regular use of OCS, baseline eosinophil count and eosinophil-to-lymphocyte ratio were significantly higher in the omalizumab non super-responder group (p = 0.015, p < 0.001, p = 0.004, p < 0.001 and p < 0.001, respectively). Blood eosinophil count (AUC: 0.187, p < 0.001), eosinophil-to-lymphocyte ratio (AUC: 0.150, p < 0.001) and FEV1 (%) (AUC:0.779, p = 0.001) were determined to have diagnostic value in predicting the treatment response to omalizumab of patients with severe allergic asthma. Conclusion High-blood eosinophil levels, CRSwNP and low pretreatment lung capacity may affect omalizumab treatment response in patients with severe allergic asthma. These results should be supported by further multicenter real-life studies.

Knowledge of, Attitudes towards, and Practices of Intranasal Corticosteroids Usage among the Allergic Rhinitis Patients of Northern Saudi Arabia: A Cross-Sectional Study.

Intranasal corticosteroids (INCS) are generally safe and effective treatments for allergic rhinitis (AR). The improper use of INCS may not alleviate AR symptoms, and it could lead to complications and an impaired quality of life. We evaluated the knowledge of, attitudes towards, and practices of INCS usage and associated factors among AR patients using a pretested Arabic questionnaire. Of the 400 participating AR patients, 39.3%, 29.0%, and 36.5% had poor scores for knowledge, attitude, and practice, respectively. We found a significant association between knowledge and education (p < 0.001) and follow-up facilities (p = 0.036). The attitude category was significantly associated with age (p = 0.003), marital status (p = 0.004), and type of allergic patients (p < 0.001), and the practice category was significantly associated with education (p = 0.027), type of allergic patients (p = 0.008), and follow-up facilities (p = 0.030). Smoking status was significantly associated with all three categories. Furthermore, we found a positive correlation between knowledge and practice scores (Spearman's rho of 0.451, p < 0.001). We recommend improving AR patients' knowledge of the proper practices of INCS through health education programs. Furthermore, we recommend an exploratory mixed-method survey on the INCS usage among AR patients that involves other provinces in the KSA.

The Joint Task Force on Practice Parameters GRADE guidelines for the medical management of chronic rhinosinusitis with nasal polyposis

These evidence-based guidelines support patients, clinicians, and other stakeholders in decisions about the use of intranasal corticosteroids (INCS), biologics, and aspirin therapy after desensitization (ATAD) for the management of chronic rhinosinusitis with nasal polyposis (CRSwNP). It is important to note that the current evidence on surgery for CRSwNP was not assessed for this guideline nor were management options other than INCS, biologics, and ATAD. The Allergy-Immunology Joint Task Force on Practice Parameters formed a multidisciplinary guideline panel balanced to include the views of multiple stakeholders and to minimize potential biases. Systematic reviews for each management option informed the guideline. The guideline panel used the Grading of Recommendations Assessment, Development and Evaluation approach to inform and develop recommendations. The guideline panel reached consensus on the following statements: (1) In people with CRSwNP, the guideline panel suggests INCS rather than no INCS (conditional recommendation, low certainty of evidence). (2) In people with CRSwNP, the guideline panel suggests biologics rather than no biologics (conditional recommendation, moderate certainty of evidence). (3) In people with aspirin (nonsteroidal anti-inflammatory drug)-exacerbated respiratory disease, the guideline panel suggests ATAD rather than no ATAD (conditional recommendation, moderate certainty of evidence). The conditions for each recommendation are discussed in the guideline.

Effects of Inhaled Corticosteroids on Bone in Asthma Patients

Background: Although inhaled corticosteroids are taken into the bloodstream, it is unclear how much damage they do to bones. The issue is crucial because 3% of people consistently use inhaled corticosteroids and could be doing for several decades. Method: In 195 adults (118 women) with asthmatic, aged 25 to 45, we examined the dose-response relationship between total inhaled corticosteroid dosage and bone mineralization concentration at the lumbar region and proximal femur. Participants had received only a little amount of systemic steroids and had routinely used an inhaled corticosteroid for a minimum of six months. Multiple regression analysis was employed to evaluate the total dosage of inhaled corticosteroid's impact on the density of bones from surveys, computerized general practitioners' data, and printed and handwritten general medical documents. Results: Treatment with inhaled corticosteroids lasted an average of 6 years (0–23), with a baseline total dose of 875 mg (87–4370). Both before and after adjusting for the influences of aging and gender, the results showed a negative correlation between the total dose of inhaled corticosteroid and skeletal mineral density at the lumbar region (L2-L4), femoral neck, and trochanter. An increase in inhaled corticosteroid dosage by twofold was linked to a 0•17 SD (95% CI 0•03-0•27) reduction in lumbar spine concentration of bone minerals... The femoral neck and trochanter all showed identical declines. The relationships remained strong after controlling for possible influencing variables such as regular exercise and previous use of oral, intranasal, cutaneous, and injectable corticosteroids. Conclusion: This investigation shows a link between the overall average dosage of inhaled corticosteroids and decreased bone mineralization concentration in asthmatic sufferers. Keywords: Corticosteroids, fracture, bone mineralization, inhaled, dosage, asthma, lumbar region, femur

Adverse Drug Reactions of Intranasal Corticosteroids in the Netherlands: An Analysis from the Netherlands Pharmacovigilance Center.

BackgroundIntranasal corticosteroids are one of the cornerstone treatment options for allergic rhinitis and chronic sinusitis complaints. Safety information in the summary of product characteristics may not be representative for observations in daily clinical practice. The Netherlands Pharmacovigilance Center (Lareb) collects post-marketing safety information, using spontaneous reporting systems.ObjectiveOur objective was to analyse reports of adverse drug reactions associated with intranasal corticosteroids reported in the Dutch spontaneous reporting database of the Netherlands Pharmacovigilance Center Lareb to obtain insight into real-world safety data.MethodsWe retrospectively examined all adverse drug reactions of intranasal corticosteroids reported to the Netherlands Pharmacovigilance Center Lareb, entered into the database from 1991 until 1 July, 2020.ResultsIn total, 2263 adverse drug reactions after intranasal corticosteroid use were reported in 1258 individuals. Headache (n = 143), epistaxis (n = 124) and anosmia (n = 57) were reported most frequently. Nasal septum perforation (reporting odds ratio 463.2; 95% confidence interval: 186.7–1149.7) had the highest reporting odds ratio, followed by nasal mucosal disorder (reporting odds ratio 104.5; 95% confidence interval 36.3–301.3) and hyposmia (reporting odds ratio 90.8; 95% confidence interval 45.1–182.7). Moreover, 101 (4.5%) reports were classified as serious by Lareb, including reports of Cushing’s syndrome, adrenal cortical hypofunction and growth retardation.ConclusionsMany side effects are consistent with the safety information in the summary of product characteristics of intranasal corticosteroids. Several serious (systemic) side effects are reported and it is important to realise that intranasal corticosteroids may contribute to the development. Healthcare providers and patients should be aware of the potential (individual) adverse drug reactions of intranasal corticosteroids. This information could help in discussing treatment options.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40801-022-00301-x.

Measuring the patient experience of chronic rhinosinusitis with nasal polyposis: qualitative development of a novel symptom diary.

BackgroundThis qualitative study assessed the experience of patients with chronic rhinosinusitis with nasal polyposis (NP) to inform the development of a novel symptom diary for clinical study use.MethodsConcept elicitation and cognitive interviews were conducted with patients who had a physician‐verified diagnosis of NP and a history of intranasal corticosteroid use. Concepts were identified via open‐ended and follow‐up questions. Relative symptom/impact disturbance level was assessed using a scale of 0 (not at all disturbing) to 10 (extremely disturbing).ResultsPatients (n = 30) attributed numerous symptoms and impacts to NP; the most prevalent and disturbing were nasal congestion (identified by 100% of patients; average disturbance rating = 7.9), nasal blockage/obstruction (97%; 8.2), difficulty with sense of smell (97%; 7.6), facial pressure (90%; 6.2), postnasal drip (87%; 6.5), runny nose (87%; 6.2), facial pain (80%; 6.3), and headache (77%; 6.5). These symptoms, along with the impact of NP on sleep and daily activities, were included in the Nasal Polyposis Symptom Diary (NPSD). Cognitive interviews confirmed that patients understood the NPSD items and could select a response reflective of their experience at its worst over the past 24 hours using a four‐point scale (none, mild, moderate, or severe).ConclusionThe most relevant and disturbing symptoms, according to patients with NP, were included in the NPSD. Interviews confirmed the suitability of NPSD in capturing the daily experience of patients. These findings support the content validity of the NPSD as a suitable tool for capturing NP symptoms and impacts.