We report an improvement in symptoms and quality of life with long-term use of guaifenesin for the treatment of mucus-related symptoms in a patient with chronic bronchitis, who presented with mucus hypersecretion, cough and dyspnea.
We report improved lung function and quality of life following daily use of guaifenesin/dextromethorphan (Mucinex DM®, Reckitt Benckiser) for the treatment of mucus-related symptoms in a patient with COPD, who presented with increasing dyspnea, progressive cough and chest congestion.
Background: Aerosolized intranasal corticosteroid formulations are desirable for many patients with allergic rhinitis (AR), especially children, who wish to avoid the "wet feeling" and "drip down the throat" associated with aqueous formulations. Beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol has been shown to be safe and effective in adolescents and adults with AR.Objective: To evaluate the efficacy and safety of BDP nasal aerosol in pediatric patients with moderate to severe seasonal AR.Methods: In this double-blinded, placebo-controlled study, children (6-11 years of age) with seasonal AR were randomized to once-daily treatment with BDP nasal aerosol 80 mu g (n = 239) or 160 mg (n = 242) or placebo (n = 234). The primary end point was change from baseline in average morning and evening reflective total nasal symptom score over the 2-week treatment period.Results: Treatment with BDP nasal aerosol showed significantly greater improvements in average morning and evening reflective total nasal symptom score vs placebo (80 mu g, -0.71; 160 mu g, -0.76; P < .001 for the 2 comparisons). Similarly, significantly greater improvements in average morning and evening instantaneous total nasal symptom score were seen with BDP nasal aerosol vs placebo (80 mu g, -0.63; 160 mu g, -0.73; P < .001 for the 2 comparisons). The incidence of adverse events from BDP nasal aerosol was comparable to that from placebo.Conclusion: BDP nasal aerosol (80 or 160 mu g/d) provided significant and clinically meaningful nasal symptom relief and an established overall safety profile similar to that of placebo, suggesting that it is an effective and well-tolerated treatment option for pediatric patients with moderate to severe seasonal AR.
Background: Despite the available treatments, asthma remains a serious illness, with a considerable socioeconomic burden associated with a high number of unscheduled visits to the emergency department (ED). Poor adherence and inadequate inhaler technique are contributing factors to poor asthma management and control.Objective: The Asthma Inhaler Design Survey assessed the behaviors, attitudes, needs, and preferences of patients with asthma and their caregivers with regard to quick-relief inhaler usage and device design.Methods: The Asthma and Allergy Foundation of America invited 19,157 adult patients and parents of children with asthma to take part in an online survey that focused on previous asthma diagnosis, symptom severity, and quick-relief and controller medication use. Opinions were also collected.Results: Data from 590 respondents (366 adults; 224 children) were included in the final analysis. Relief inhalers were needed and found to be past the expiration date by 284 of 561 (50.6%) and relief inhalers were found to be empty by 270 of 560 (48.2%). Of the empty inhaler group, 28 of 270 (10.4%) had to visit the ED for treatment, 18 of 270 (6.7%) missed work or school for an unscheduled physician office visit, and 54 of 270 (20%) went without treatment. Although 78.5% indicated that they had at least two quick-relief inhalers nearby, these were not always easily accessible. Few respondents (194/578 [33.6%]) indicated that they and/or their child were very confident that they were using their inhaler properly, even though the majority had received some instruction. When asked what they would do to improve satisfaction with their quick-relief inhalers, 173 of 558 (31%) responded that they would add a dose counter.Conclusion: Unnecessary health care utilization and avoidable loss of time at work or school were associated with the lack of full availability of properly functioning quick-relief inhalers when needed. Adding a dose counter was the most frequently cited response for improving satisfaction with quick-relief inhalers. Confidence about proper inhaler use was low, despite previous instruction.
Allergic rhinitis (AR) affects at least 60 million people in the United States each year, resulting in a major impact on patient quality of life, productivity, and direct and indirect costs. As new therapies, data, and literature emerge in the management of AR, there is a need to communicate and disseminate important information to health care professionals to advance the practice of medicine and lessen the disease burden from AR. Treatment recommendations for AR have not been updated since the 2012 Food and Drug Administration approval of nonaqueous intranasal aerosol agents using hydrofluoroalkane propellants and the first aqueous intranasal combination product. Here, we present an updated algorithm for the pharmacologic treatment of AR that includes these new treatment options. Treatment recommendations are categorized by disease severity (mild versus moderate/severe) and duration of symptoms (episodic versus nonepisodic, with episodic defined as <3 days/wk or for <3 weeks). Preferred treatments are suggested, as well as alternative options for consideration by clinicians in the context of individual patient needs. This recommendation article also outlines the importance of treatment monitoring, which can be conducted using the recently developed Rhinitis Control Assessment Test. Successful therapeutic outcomes depend on multiple factors, including use of the most effective pharmacologic agents as well as patient adherence to therapy. Therefore, it is imperative that rhinitis patients not only receive the most effective therapeutic options, but that they also understand and are able to adhere to the comprehensive treatment regimen. Successful treatment, with all of these considerations in mind, results in better disease outcomes, improved quality of life for patients, and greater economic productivity in the home and workplace.
Intranasal corticosteroids (INSs) have been effectively used for >40 years for the treatment of seasonal allergic rhinitis (SAR) and perennial AR (PAR). Following the Montreal Protocol, the initial aerosol formulations using chlorofluorocarbon (CFC) propellants were phased out. For the past 20 years, aqueous solutions have been the only available option for INS treatment. In 2012, the U.S. Food and Drug Administration approved two new nonaqueous aerosol AR treatments that use a hydrofluoroalkane (HFA) propellant. In 2012, the first intranasal aqueous combination product was also approved. This article reviews the clinical profiles of HFA beclomethasone dipropionate (BDP) and HFA ciclesonide (CIC) and the aqueous combination intranasal antihistamine (INA)/INS formulation of azelastine hydrochloride/fluticasone propionate (AZE/FP). The medical literature was searched for clinical trials investigating the use of BDP, CIC, and AZE/FP in SAR and PAR. Clinical trials involving aqueous solutions and CFC propellant or HFA propellant delivery were included. Data from prescribing information and published efficacy and safety data were presented as part of the clinical profile for the reviewed agents. AZE/FP has shown efficacy and safety comparable or greater with the current AR treatment options. Although efficacy comparisons of new HFA formulations have not been investigated in head-to-head clinical trials with aqueous formulations, HFA formulations have shown similar efficacy rates. Furthermore, HFA formulations may have some additional benefits, including a preferable sensory profile for some patients. These new formulations will provide additional options for clinicians and patients to better individualize therapy for control of AR.
This article summarizes the findings of an expert panel of nationally recognized allergists and pulmonologists who met to discuss how to improve detection and diagnosis of exercise-induced bronchoconstriction (EIB), a transient airway narrowing that occurs during and most often after exercise in people with and without underlying asthma. EIB is both commonly underdiagnosed and overdiagnosed. EIB underdiagnosis may result in habitual avoidance of sports and physical activity, chronic deconditioning, weight gain, poor asthma control, low self-esteem, and reduced quality of life. Routine use of a reliable and valid self-administered EIB screening questionnaire by professionals best positioned to screen large numbers of people could substantially improve the detection of EIB. The authors conducted a systematic review of the literature that evaluated the accuracy of EIB screening questionnaires that might be adopted for widespread EIB screening in the general population. Results of this review indicated that no existing EIB screening questionnaire had adequate sensitivity and specificity for this purpose. The authors present a call to action to develop a new EIB screening questionnaire, and discuss the rigorous qualitative and quantitative research necessary to develop and validate such an instrument, including key methodological pitfalls that must be avoided. (C) 2014 American Academy of Allergy, Asthma & Immunology
BACKGROUND:Exercise-induced bronchoconstriction (EIB) describes acute airway narrowing that occurs as a result of exercise. EIB occurs in a substantial proportion of patients with asthma, but may also occur in individuals without known asthma. METHODS:To provide clinicians with practical guidance, a multidisciplinary panel of stakeholders was convened to review the pathogenesis of EIB and to develop evidence-based guidelines for the diagnosis and treatment of EIB. The evidence was appraised and recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluation approach. RESULTS:Recommendations for the treatment of EIB were developed. The quality of evidence supporting the recommendations was variable, ranging from low to high. A strong recommendation was made for using a short-acting β(2)-agonist before exercise in all patients with EIB. For patients who continue to have symptoms of EIB despite the administration of a short-acting β(2)-agonist before exercise, strong recommendations were made for a daily inhaled corticosteroid, a daily leukotriene receptor antagonist, or a mast cell stabilizing agent before exercise. CONCLUSIONS:The recommendations in this Guideline reflect the currently available evidence. New clinical research data will necessitate a revision and update in the future.
Assessment of the long-term effects of intranasal corticosteroids is important for their safe and effective use. The objective of this study was to evaluate the long-term safety and tolerability of hydrofluoroalkane nasal aerosol formulation of ciclesonide (CIC-HFA) which is in clinical development, following 26 weeks of treatment. Patients ≥12 years of age with a ≥2 year history of perennial allergic rhinitis (PAR) who had completed a 26-week efficacy and safety study of treatment with CIC-HFA 74 μg, CIC-HFA 148 μg, or placebo were eligible. In this open-label, multi-center, long-term extension study, patients received CIC-HFA 148 μg (N=824) QD AM for an additional 26 weeks. Safety assessments were patient-reported adverse events (AEs), and specific nasal AEs on examination including epistaxis, nasal ulcerations and nasal septal perforations during the 26-week treatment period. Efficacy assessments were change from baseline in morning reflective and instantaneous total nasal symptom score (AM rTNSS & AM iTNSS) at the end of the 26-week treatment period. A total of 431 (52.3%) patients reported AEs (≥2% of patients reporting any AE)). The most common AE was upper respiratory tract infection, (N=61, 7.4%).Specific nasal AEs were epistaxis (N=46, 5.6%), nasal septum disorder (N=13, 1.6%), nasal septum ulceration (N=4, 0.5%), and nasal discomfort (N=2, 0.2%). Improvement in AM rTNSS and AM iTNSS from baseline were observed following treatment with CIC-HFA 148 μg dose for 26 weeks. In this study, once-daily treatment with CIC-HFA 148 μg for 26 weeks was well tolerated and showed improvements in the nasal symptoms of PAR.
Controlled clinical trials have shown the recombinant humanized monoclonal anti-IgE antibody omalizumab to improve asthma control and reduce symptom exacerbations in patients with moderate-to-severe allergic asthma who remain clinically unstable despite optimal medical therapy. An objective retrospective review compared clinical experience with the data reported in the controlled studies. Data tracking for 167 patients progressively enrolled between 2003 and 2010 treated with omalizumab included symptoms, forced expiratory volume at 1 second (FEV(1)), systemic steroid bursts, and need for short-acting bronchodilator rescue measured at the start of therapy; 3, 6, and 12 months after starting treatment, and yearly thereafter. Exacerbations were compared for the 12 months before and the 12 months after starting treatment in a subgroup of patients. Asthma control improved with omalizumab over time (up to 6 years) as indicated by fewer symptoms and less need for rescue medication (p < 0.001 for both). FEV(1) remained stable. The number of patients reporting asthma exacerbations requiring urgent care decreased by 49% during the first 12 months of treatment (p ≤ 0.01), and significant reductions in exacerbations were also evident when measured by hospitalizations or systemic corticosteroid bursts (p < 0.001 for both). This is the first long-term pragmatic review of omalizumab. Our clinical experience (up to 6 years in some patients) supports the results of earlier controlled studies, confirming the usefulness of adding omalizumab to the long-term management of patients with difficult-to-treat disease who suffer from persistent symptoms despite optimal therapy with medications.
People with allergic rhinitis rate their overall health significantly lower than individuals without nasal allergies. Compared with the general population, more people with AR complain of difficulty getting to sleep, waking up during the night, lack of a good night's sleep, or a combination of these, as a result of their nasal symptoms. More than half of individuals with AR describe their symptoms as impacting daily life a lot or to a moderate degree. More adults with AR report that their health limits them from doing well at work compared with adults without nasal allergies, and their estimated productivity drops by an average of 20% on days when their nasal symptoms are at their worst.
Published Practice Parameters of the Joint Task Force on Practice Parameters for Allergy & Immunology include the following: 1Practice parameters for the diagnosis and treatment of asthma. J Allergy Clin Immunol. 1995;96(suppl):S707–S870. 2Practice parameters for allergy diagnostic testing. Ann Allergy. 1995;75:543–625. 3Practice parameters for the diagnosis and management of immunodeficiency. Ann Allergy. 1996;76:282–294. 4Practice parameters for allergen immunotherapy. J Allergy Clin Immunol. 1996;98:1001–1011. 5Disease management of atopic dermatitis: a practice parameter. Ann Allergy. 1997;79:197–211. 6The diagnosis and management of anaphylaxis. J Allergy Clin Immunol. 1998;101(suppl):S465–S528. 7Algorithm for the diagnosis and management of asthma: a practice parameter update. Ann Allergy. 1998;81:415–420. 8Diagnosis and management of rhinitis: parameter documents of the Joint Task Force on Practice Parameters in Allergy, Asthma and Immunology. Ann Allergy. 1998;81(suppl):S463–S518. 9Parameters for the diagnosis and management of sinusitis. J Allergy Clin Immunol. 1998;102(suppl):S107–S144. 10Stinging insect hypersensitivity: a practice parameter. J Allergy Clin Immunol. 1999;103:963–980. 11Disease management of drug hypersensitivity: a practice parameter. Ann Allergy. 1999;83(suppl):S665–S700. 12Diagnosis and management of urticaria: a practice parameter. Ann Allergy. 2000;85(suppl):S521–S544. 13Allergen immunotherapy: a practice parameter. Ann Allergy. 2003;90(suppl):SI–S540. 14Symptom severity assessment of allergic rhinitis: part I. Ann Allergy. 2003;91:105–114. 15Disease management of atopic dermatitis: an updated practice parameter. Ann Allergy. 2004;93:S1–S21. 16Stinging insect hypersensitivity: a practice parameter update. J Allergy Clin Immunol. 2004;114:869–886. 17The diagnosis and management of anaphylaxis: an updated practice parameter. J Allergy Clin Immunol. 2005;115:S483–S523. 18Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy. 2005;94:S1–S63. 19Attaining optimal asthma control: a practice parameter. J Allergy Clin Immunol. 2005;116:S3–S11. 20The diagnosis and management of sinusitis: a practice parameter update. J Allergy Clin Immunol. 2005;116:S13–S47. 21Food allergy: a practice parameter. Ann Allergy. 2006;96:S1–S8. 22Contact dermatitis: a practice parameter. Ann Allergy. 2006;97:S1–S38. 23Allergen immunotherapy: a practice parameter second update. J Allergy Clin Immunol. 2007;120:S25–S85. 24Allergy diagnostic testing: an updated practice parameter. Ann Allergy. 2008;100:S1–S147. 25Diagnosis and management of rhinitis: an updated practice parameter. J Am Coll Immunol. 2008;121:S1–S84. 26Kelso J, Li JT. Adverse reactions to vaccines. Ann Allergy. 2009;103:S1–S16. 27Lieberman P, et al. The diagnosis and management of anaphylaxis practice parameter: 2010 Update. J Allergy Clin Immunol 2010: 126(3):477–480.e.42. 28Solensky R, et al. Drug Allergy: An Updated Parameter. Ann Allergy 2010;105:273e.1–273e.78.
Exercise-induced bronchospasm (EIB) is a relatively common condition that affects both recreational and elite athletes. The latest data suggest that it is an inflammatory process, especially in elite athletes. Proper diagnosis is important to differentiate EIB from other respiratory conditions. Effective treatment usually controls this condition.
Triamcinolone acetonide (TAA) aerosol nasal inhaler is an effective and well-tolerated treatment for symptoms of perennial allergic rhinitis (PAR). This multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of once-daily administration of TAA aerosol nasal inhaler (220 mu g) in a pediatric population 6-11 years of age, with a documented history of PAR, a positive skin prick test for perennial allergens, and a minimum qualifying total rhinitis symptom score (greater than or equal to 24 points of a possible 48). One hundred thirty-seven patients received either TAA aerosol nasal inhaler (220 mu g/day) or placebo once daily for 4 weeks. Patients evaluated the severity of PAR symptoms (nasal stuffiness, discharge, sneezing, itching) daily according to a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Patients' and physicians' global evaluations of overall treatment effectiveness were assessed after the 4-week treatment period. Patients treated with TAA aerosol nasal inhaler had significantly (p < 0.05) greater reductions in all nasal symptom scores overall and in nasal stuffiness and nasal index at the end of weeks 1, 2, 3, and 4 compared with the placebo group. Both patients' and physicians' global evaluations of efficacy favored TAA aerosol nasal inhaler compared with placebo. Adverse events mere mild and comparable between the two groups. This study demonstrated that once-daily administration of TAA aerosol nasal inhaler (220 mu g) was well tolerated and effective in reducing the symptoms of PAR in pediatric patients.
Exercise and physical activity are common triggers of symptoms in patients with asthma, although some individuals - especially athletes - may have symptoms with exercise alone. Exercise-induced bronchospasm (EIB) describes airway hyper-reactivity that is observed following exercise in a patient who is not otherwise diagnosed with asthma; exercise-induced asthma (EIA) describes airway hyper-reactivity associated with exercise in a patient who has persistent asthma. Specific challenges affecting both the diagnosis and treatment of these conditions are discussed in this review. The past decade has seen substantial advances in our understanding of EIA and EIB, including new guidelines on their management. With appropriate therapy, all patients with exercise-related symptoms should be able to reach their desired level of performance.
It has long been recognized, even during biblical times, that physical exercise may induce asthma symptoms in susceptible individuals.1 Nevertheless, the term exercise-induced asthma (EIA) only became popular in the 1960s and 1970s when several reports addressed the pattern of airway response to exercise and the influence of drugs on EIA, particularly in children.2,3 Subsequently, reports of studies of the mechanisms causing EIA4 often asserted that EIA represents a distinct clinical category of asthma.