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Publications (25)87.82 Total impact

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    ABSTRACT: Although the common cold is among the most frequent ailments encountered in clinical practice, little is known about its impact on productivity, absenteeism, and daily life. The United States Attitudes of Consumers Toward Health, Cough, and Cold (ACHOO) survey was developed to inform healthcare providers on patients' experience of cough/cold. This analysis focuses on the impact of cough/cold on daily activity, productivity, and absenteeism; other results are reported elsewhere. ACHOO was a 36-question online survey. US adult Internet/mobile device users (N=3333) were recruited in October 2012. Response quotas modeled on 2010 US Census data ensured a demographically representative sample; 75% of completed surveys were randomized as the primary analysis pool. Demographics and impact of cough/cold were reported using means, frequencies, and percentages. Weighted least squares regression or weighted paired t-test were used to identify factors associated with greater impact. The analysis pool (n=2505) included 1342 (53.6%) women and 1163 (46.4%) men (mean ages, 46.7 and 45.9 years). A majority (84.7%) had ≥1 cold in the past year. Fifty-two percent said cough/cold impacted daily life a fair amount to a lot. Productivity decreased by a mean 26.4%, and 44.5% of respondents reported work/school absenteeism (usually 1-2 days) during a cold. Overall, 93% of survey participants reported sleep difficulty (slight to extreme) during a cough/cold. Among all respondents, 57% reported cough or nasal congestion as the symptoms making sleep difficult. Higher frequency of colds, more cold symptoms, difficulty sleeping, and worse overall health status correlated with greater impact on productivity, absenteeism, and daily life. Study limitations include the potential for recall bias given the retrospective nature of the self-reports. Furthermore, no attempt was made to distinguish treatment effects, if any, from those of the underlying cough/cold. To our knowledge, this is the first large national survey to quantify adverse effects of cough/cold on daily activity, productivity, and absenteeism. Cold- and patient-related characteristics influence the degree of impact.
    Current Medical Research and Opinion 06/2015; DOI:10.1185/03007995.2015.1062355 · 2.37 Impact Factor
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    ABSTRACT: Objective: The Attitudes of Consumers Toward Health, Cough, and Cold (ACHOO) survey was developed to better inform health care providers on the natural history and impact of common cold and cough, and related consumer experience and behaviors. Research design and methods: Randomly selected US Internet/mobile device users were invited to participate in an online survey (N = 3333) in October 2012. Response quotas modeled upon 2010 US Census data ensured a demographically representative sample. To reduce potential bias from the quota design, 75% of the completed surveys were randomly selected as the primary analysis pool. Main outcome measures: Survey questions assessed participant demographics, frequency and duration of cough/cold symptoms, impact of symptoms on daily life, treatment preferences, and knowledge about cough/cold pathophysiology. Results: In the past year, 84.6% of respondents had experienced at least one cold. Colds typically started with sore/scratchy throat (39.2%), nasal congestion (9.8%), and runny nose (9.3%) and lasted 3–7 days. Cough, the most common cold symptom (73.1%), had a delayed onset (typically 1–5 days after cold onset) and a long duration (>6 days in 35.2%). Nasal congestion and cough were the most bothersome symptoms. Many respondents waited until symptoms were ‘bad enough’ (42.6%) or multiple symptoms were present (20.2%) before using nonprescription medications. Drivers of choice included effectiveness in relieving symptoms, safety, and past experience. Respondents rarely consulted clinicians regarding treatment, and more than three-quarters had never received instructions from a clinician on how to choose a nonprescription cough/cold medication. Misperceptions regarding etiology and treatment of the common cold were prevalent. The main limitation is potential recall bias, since respondents had to recall cough/cold episodes over the prior year. Conclusions: The ACHOO survey confirms that cold is a common, bothersome experience and that there are gaps in consumers’ knowledge of pathophysiology and appropriate management of cough/cold.
    Current Medical Research and Opinion 02/2015; DOI:10.1185/03007995.2014.1002558 · 2.37 Impact Factor
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    ABSTRACT: Allergic rhinitis (AR; also nasal allergies or "hay fever") is a chronic upper airway inflammatory disease that affects ∼60 million adults and children in the United States. The duration and severity of AR symptoms contribute to a substantial burden on patients' quality of life (QoL), sleep, work productivity, and activity. This study was designed to examine symptoms, QoL, productivity, comorbidities, disease management, and pharmacologic treatment of AR in United States and ex-U.S. sufferers. Allergies in America was a comprehensive telephone-based survey of 2500 adults with AR. These data are compared and contrasted with findings from the Pediatric Allergies in America, Allergies in Latin America, and Allergies in Asia-Pacific telephone surveys. The prevalence of physician-diagnosed AR was 14% in U.S. adults, 7% in Latin America adults, and 9% in Asia-Pacific adults. Nasal congestion is the most common and bothersome symptom for adults. Approximately two-thirds of adults rely on medication to relieve intolerable AR symptoms. Incomplete relief, slow onset, <24-hour relief, and reduced efficacy with sustained use were commonly reported with AR medications, including intranasal corticosteroids. One in seven U.S. adults reported achieving little to no relief with AR medications. Bothersome adverse effects of AR medications included drowsiness, a drying feeling, medication dripping down the throat, and bad taste. Perception of inadequate efficacy was the leading cause of medication discontinuation or change and contributed to treatment dissatisfaction. These findings support the assertion that AR burden has been substantially underestimated and identify several important challenges to successful management of AR.
    Allergy and Asthma Proceedings 09/2012; 33 Suppl 1:S113-41. DOI:10.2500/aap.2012.33.3603 · 3.35 Impact Factor
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    ABSTRACT: Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development for treatment of allergic rhinitis. This Phase I study evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of CIC-HFA in healthy subjects (N = 18) and subjects with perennial allergic rhinitis (PAR, N = 18) in a double-blind, placebo-controlled, 3-period crossover design following treatment with 282 μg or 148 μg CIC-HFA or placebo once-daily for 14 days. The concentrations of desisobutyryl-ciclesonide (des-CIC), the pharmacologically active metabolite of CIC were measured by a validated high performance liquid chromatography with tandem mass spectrometry. Maximum serum concentration (C(max)), area under the serum concentration time curve (AUC), time to maximum serum concentration (t(max)) and elimination half life (t(1/2)) where feasible, were calculated. Serum cortisol (AUC(0-24h)) and adverse events (AE) were also evaluated. The overall systemic exposure of des-CIC was low. The mean C(max) for des-CIC on Day 14 was 35.84 ng/L and 25.98 ng/L for the CIC-HFA 282 μg and CIC-HFA 148 μg treatment groups respectively. Mean AUC((0, last)) for des-CIC on Day 14 was 213 ng·h/L and 112.3 ng·h/L for CIC-HFA 282 μg and 148 μg respectively. Mean serum cortisol (AUC(0-24h)) was similar for CIC-HFA 282 μg (178 μg·h/dL), CIC-HFA 148 μg (169 μg·h/dL), and placebo (174 μg·h/dL) on Day 14. The overall incidence of AEs was low and headache and epistaxis were the most common individual AEs reported. In this study, systemic exposure of des-CIC was low and similar in healthy subjects and subjects with PAR with no evidence of clinically relevant accumulation over the 14 day treatment period in either treatment group. Both doses of CIC-HFA were well tolerated without significant effect on cortisol levels.
    Pulmonary Pharmacology &amp Therapeutics 08/2011; 24(4):426-33. DOI:10.1016/j.pupt.2011.04.002 · 2.57 Impact Factor
  • Hugo Neffen, Mark A. Wingertzahn
    Allergy and Asthma Proceedings 07/2010; 31(4):354-354. · 3.35 Impact Factor
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    ABSTRACT: Allergies in Latin America is the first cross-national survey that describes the symptoms, impact, and treatment of nasal allergies (NAs) in individuals >or=4 years old in Latin America (LA). In total, 22,012 households across the Latin American countries of Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, and Venezuela were screened for children, adolescents, and adults with a diagnosis of NA and either symptoms or treatment in the past 12 months. A total of 1088 adults and 457 children and adolescents were included and the sample was probability based to ensure valid statistical inference to the population. Approximately 7% of the LA population was diagnosed with NAs with two of three respondents stating that their allergies were seasonal or intermittent in nature. A general practice physician or otolaryngologist diagnosed the majority of individuals surveyed. Nasal congestion was the most common and bothersome symptom of NAs. Sufferers indicated that their symptoms affected productivity and sleep and had a negative impact on quality of life. Two-thirds of patients reported taking some type of medication for their NAs, with a roughly equal percentage of patients reporting taking over-the-counter versus prescription medications. Changing medications was most commonly done in those reporting inadequate efficacy. The most common reasons cited for dissatisfaction with current medications were related to inadequate effectiveness, effectiveness wearing off with chronic use, failure to provide 24-hour relief, and bothersome side effects (e.g., unpleasant taste and retrograde drainage into the esophagus). Findings from this cross-national survey on NAs have confirmed a high prevalence of physician-diagnosed NAs and a considerable negative impact on daily quality of life and work productivity as well as substantial disease management challenges in LA. Through identification of disease impact on the LA population and further defining treatment gaps, clinicians in LA may better understand and treat NAs, thus leading to improvements in overall patient satisfaction and quality of life.
    Allergy and Asthma Proceedings 05/2010; 31 Suppl 1(3):S9-27. DOI:10.2500/aap.2010.31.3347 · 3.35 Impact Factor
  • Hugo Neffen, Mark A Wingertzahn
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    ABSTRACT: Intranasal corticosteroids (INCSs) are established as the first-line treatment of moderate to severe allergic rhinitis (AR) in both adults and children. Compared with other nasal allergy medications, INCSs are the most effective at providing symptom relief and increasing quality of life. Ciclesonide nasal spray is the most recently approved INCS. The formulation of ciclesonide does not contain benzylalkonium chloride or phenyl ethyl alcohol, excipients that have been associated with reduced mucociliary transport, and unpleasant sensory perceptions. Additionally, ciclesonide has been formulated in a hypotonic suspension that has been shown to optimize intranasal absorption and it has a lower volume of spray compared with most other INCS products. Systemic exposure to ciclesonide and its active metabolite desisobutyryl-ciclesonide is low after intranasal administration. High protein binding ( approximately 99%) and rapid first-pass clearance further reduce systemic exposure to the drug. Studies up to 1 year have shown that intranasal ciclesonide does not cause cortisol suppression as monotherapy and does not have an additive effect on the hypothalamic-pituitary-adrenal axis function when administered in combination with inhaled corticosteroids. The efficacy of ciclesonide, 200 microg/day, has been shown in pediatric, adolescent, and adult patients with moderate to severe seasonal AR and perennial AR treated for up to 1 year. Additionally, environmental exposure unit studies have established an onset of action as early as 1 hour after administration. Ciclesonide nasal spray has also been shown to have an acceptable safety profile in patients with AR as young as 2 years of age. Thus, intranasal ciclesonide appears to provide an additional effective treatment option for patients with AR.
    Allergy and Asthma Proceedings 05/2010; 31 Suppl 1(3):S29-37. DOI:10.2500/aap.2010.31.3348 · 3.35 Impact Factor
  • Ruediger Nave, Rolf Herzog, Aziz Laurent, Mark A Wingertzahn
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    ABSTRACT: Ciclesonide, an intranasal corticosteroid, is administered as a prodrug and is converted to the active metabolite, desisobutyryl ciclesonide, in the upper and lower airways. Previous studies have assessed systemic exposure with the ciclesonide hydrofluoroalkane metered dose inhaler (CIC HFA-MDI) and the ciclesonide aqueous nasal spray (CIC-AQ) formulations. However, systemic exposure with ciclesonide HFA nasal aerosol (CIC-HFA) developed for the treatment of allergic rhinitis has not been investigated. This study compared the systemic exposure of ciclesonide and desisobutyryl ciclesonide after administration of ciclesonide formulated as an aqueous nasal spray, an HFA nasal aerosol, or as an orally inhaled HFA-MDI. Healthy adults (aged 18-60 years) were randomly assigned in an open-label, singledose, 3-period crossover design to CIC-AQ 300 microg, CIC-HFA 300 microg, or CIC HFA-MDI 320 microg. Serum samples were collected before study drug administration and at 5, 15, and 30 minutes and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, 18, 22, and 24 hours after dosing. The primary pharmacokinetic parameters were AUC(0-infinity) and C(max) of desisobutyryl ciclesonide. Adverse events were elicited by direct questioning of participants throughout the study. Thirty volunteers were randomly assigned. Most of the volunteers were male (63% [19/30]) and white (83% [25/30]); the mean age was 36 years and mean weight was 68 kg. Concentrations of desisobutyryl ciclesonide were quantifiable (lower limit of quantitation [LLOQ] = 10 ng/L) in the serum samples of only 5 volunteers (of 30) receiving CIC-AQ, and the highest C(max) value of desisobutyryl ciclesonide was 26.7 ng/L (mean C(max), 15.2 ng/L). The AUC(0-infinity) of desisobutyryl ciclesonide for CIC-AQ was below the LLOQ of the bioanalytic assay. Mean C(max) and AUC(0-infinity) of desisobutyryl ciclesonide were 59.1 ng/L and 397.5 ng . h/L, respectively, for CIC-HFA; and 586.2 ng/L and 2685.0 ng . h/L, respectively, for CIC HFA-MDI. Concentrations of the parent compound, ciclesonide, were below the LLOQ in serum samples after administration of CIC-AQ; they were detectable up to 2 hours after administration of CIC-HFA and up to 4 hours after administration of CIC HFA-MDI. Treatment-emergent adverse events occurred with a low frequency in all 3 treatment groups (30% [9/30] overall) and were mild in intensity as determined by the study investigator. In this study, compared with that of CIC HFA-MDI, the systemic exposure of desisobutyryl ciclesonide was 10-fold lower after administration of CIC-HFA and at least 40-fold lower after administration of CIC-AQ. All treatments were well tolerated.
    Clinical Therapeutics 12/2009; 31(12):2988-99. DOI:10.1016/j.clinthera.2009.12.002 · 2.59 Impact Factor
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    ABSTRACT: Aerosol-based corticosteroid nasal formulations may be preferred over current aqueous nasal sprays by some patients because they traditionally cause less pharyngeal and anterior nose runoff. To determine the optimal dose, safety, and tolerability of ciclesonide hydrofluoroalkane nasal aerosol in patients with seasonal allergic rhinitis (SAR). Patients 12 years or older with a history of SAR received ciclesonide hydrofluoroalkane nasal aerosol to a total dose of 75, 150, or 300 microg or placebo once daily (half dose per nostril) for 2 weeks. The primary efficacy assessment was patient-reported average morning and evening reflective (24-hour) total nasal symptom scores (rTNSS). Secondary efficacy assessments included patient-reported average morning and evening instantaneous TNSS (iTNSS), patient-reported morning iTNSS, physician-assessed nasal signs and symptom severity, and Rhinoconjunctivitis Quality of Life Questionnaire responses. Safety and tolerability were also assessed. Ciclesonide hydrofluoroalkane nasal aerosol demonstrated a statistically significantly greater reduction from baseline in average morning and evening rTNSS (24-hour) vs placebo, with treatment differences as follows: 0.81 (P = .001; 300 microg), 0.90 (P < .001; 150 microg), and 0.66 (P = .01; 75 microg). Improvements in average morning and evening iTNSS and patient-reported morning iTNSS were also significantly improved regardless of dose (P < or = .003 for all ciclesonide groups vs placebo). The incidence of treatment-related adverse events was low (< 1.6% for all) and similar among groups. Ciclesonide hydrofluoroalkane nasal aerosol demonstrated statistically significant improvements in SAR symptoms vs placebo. On the basis of comparable efficacy and safety profiles observed for all doses, these results suggest that the 75-microg and 150-microg doses of ciclesonide hydrofluoroalkane appear appropriate for further evaluation of efficacy.
    Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 08/2009; 103(2):166-73. DOI:10.1016/S1081-1206(10)60171-8 · 2.75 Impact Factor
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    ABSTRACT: Allergic rhinitis (AR), a chronic inflammatory disease of the upper airway, is one of the most common chronic diseases in the United States and is estimated to affect up to 60 million people. Pediatric Allergies in America is the largest and most comprehensive survey to date of pediatric patients and parents of patients with allergy, as well as health care providers (HCPs), regarding AR in children and its treatment. The goals of the survey were to determine the prevalence of AR in the US pediatric population and to collect information on what effect the condition has on patients in terms of symptom burden, quality of life, productivity, disease management, and pharmacologic treatment. This national survey screened 35,757 households to identify 500 children with HCP-diagnosed nasal allergies and 504 children without nasal allergies who were between the ages of 4 and 17 years. Parents of young children, as well as children 10 to 17 years of age, were questioned about the condition and its treatment. In parallel, 501 HCPs were interviewed. This survey has captured previously unavailable data on the prevalence of nasal allergies and their most common and most bothersome symptoms, on the effect of nasal allergies on the quality of life of children, and on medication use, including both over-the-counter and prescription medications, and has identified factors affecting satisfaction with treatment. The Pediatric Allergies in America survey also identifies distinct areas for improvement in the management of AR in children. In fact, based on the results of this survey, it appears that HCPs overestimate patients' and parents' satisfaction with disease management and the benefit of medications used for the treatment of nasal allergies in children. Findings from this national survey have identified important challenges to the management of AR, suggesting that its burden on children in the United States has been significantly underestimated.
    The Journal of allergy and clinical immunology 08/2009; 124(3 Suppl):S43-70. DOI:10.1016/j.jaci.2009.05.013 · 11.25 Impact Factor
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    ABSTRACT: Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR). To evaluate the time to onset of action of ciclesonide, 200 microg/d, in patients with seasonal AR (SAR). In a double-blind, randomized, placebo-controlled study conducted in an environmental exposure chamber, 509 adults with at least a 2-year history of SAR completed 1 to 5 priming sessions of ragweed pollen exposure (mean [SD] of 3,500 [500] grains/m3). Patients with successful priming visits (defined as patient-assessed instantaneous total nasal symptom scores [TNSSs] > or =6 and rhinorrhea or nasal congestion scores -2) received a single dose of intranasal ciclesonide, 200 microg (n = 255), or placebo (n = 254). The difference in the change from baseline in TNSSs between the ciclesonide and placebo groups was measured hourly 1 to 12 hours after study drug administration. At hour 6, the mean treatment difference in TNSSs between ciclesonide and placebo was 0.53 (95% confidence interval, 0.03-1.03; P = .02). Significant treatment differences in favor of ciclesonide were also observed at 2 additional time points: hour 10 (P = .01) and hour 12 (P = .008). These results confirm that intranasal ciclesonide, 200 microg/d, has an onset of action of 6 hours in patients with SAR.
    Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 02/2009; 102(1):62-8. DOI:10.1016/S1081-1206(10)60110-X · 2.75 Impact Factor
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    ABSTRACT: Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis. We conducted a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the time to onset of action of ciclesonide 200 microg once daily in 502 adults with seasonal allergic rhinitis of at least 2 years' duration. To trigger immunologic priming, patients underwent between one and five priming sessions with exposure to 3,500 grains/m(3) (+/-500) of ragweed pollen in an environmental exposure chamber. The criteria for a successful priming session were a patient-assessed instantaneous total nasal symptom score of at least 6 (of a possible 12) and a nasal congestion or rhinorrhea score of at least 2 (of a possible 3) 90 minutes after allergen exposure during at least two consecutive priming sessions. Patients were then randomly assigned to receive either a single dose of ciclesonide 200 microg (n = 251) or placebo (n = 251) administered intranasally. The difference in the change from baseline total nasal symptom scores in the two groups was assessed hourly for 12 hours after administration. Onset of action was determined to have taken place the first time that the effects of ciclesonide, as reflected in the total nasal symptom score, were significantly greater than those of placebo at a particular hourly assessment, provided that the subsequent hourly assessment also showed a statistically significant difference. The onset of action of ciclesonide occurred within 1 hour of administration (p = 0.01 vs. placebo), and the significant difference in total nasal symptom scores between ciclesonide and placebo was maintained through post-treatment hour 12 (p = 0.018).
    Ear, nose, & throat journal 07/2008; 87(6):340-53. · 0.88 Impact Factor
  • Pediatric Asthma Allergy &amp Immunology 06/2008; 21(2):73-82. DOI:10.1089/pai.2007.0022.73
  • Pediatric Asthma Allergy &amp Immunology 12/2007; 20(4):229-242. DOI:10.1089/pai.2007.002
  • Paul Ratner, Patrick Darken, Mark Wingertzahn, Tushar Shah
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    ABSTRACT: Coexisting asthma and allergic rhinitis (AR) are often treated with both intranasal and inhaled corticosteroids. This study investigated whether intranasal ciclesonide 200 microg once daily has an additional effect on cortisol suppression when coadministered with inhaled hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP). Adult patients (n = 150) with perennial AR received HFA-BDP 320 microg twice daily and placebo once daily during a run-in period. Patients were then randomized to ciclesonide or placebo and HFA-BDP (43 days). A single 2-mg dose of dexamethasone was administered on the last treatment day. Plasma cortisol decreased by 67.8 microg x h/dL (p < 0.001) during the run-in period. When ciclesonide was added, the change in mean plasma cortisol was similar for ciclesonide and placebo (8.5 microg x h/dL and 1.0 microg x h/dL, respectively). Dexamethasone decreased mean plasma cortisol (p < 0.001), demonstrating that further cortisol suppression was possible. This study suggests that intranasal ciclesonide can be used with an inhaled corticosteroid without increased cortisol suppression.
    Journal of Asthma 11/2007; 44(8):629-33. DOI:10.1080/02770900701554359 · 1.83 Impact Factor
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    ABSTRACT: The nasal tissue uptake and metabolism of ciclesonide, a new-generation corticosteroid under investigation for treatment of allergic rhinitis, to its active metabolite, desisobutyryl-ciclesonide (des-CIC), was evaluated when administered to rabbits in a hypotonic versus an isotonic ciclesonide suspension. Nasal mucosa extracts from normal Japanese white rabbits were evaluated by high-performance liquid chromatography with tandem mass spectrometry detection after a single 143-mug dose of ciclesonide. Retention and formation of fatty acid conjugates of des-CIC were also measured in nasal mucosa extracts postadministration of a hypotonic ciclesonide suspension (143-mug single dose). Versus an isotonic suspension, the hypotonic suspension achieved higher concentrations of des-CIC (5.6-fold, 11.4-fold, and 13.4-fold; p < 0.05 for all) and ciclesonide (25.3-fold, 34.2-fold [p = not significant], and 16-fold [p < 0.05]) at 30, 120, and 240 min postadministration. Additionally, when administered via a hypotonic suspension, des-CIC was retained up to 24 h postadministration (45.46 pmol/g tissue). Highest concentration of major fatty acid ester conjugate, des-CIC-oleate, was detected in nasal mucosa at 8 h postadministration. These data suggest that a hypotonic ciclesonide suspension provides higher intracellular concentrations of des-CIC up to 24 h, thereby providing a rationale for investigation of ciclesonide as a convenient once-daily nasal spray for treatment of allergic rhinitis.
    BMC Pharmacology 06/2007; 7:7. DOI:10.1186/1471-2210-7-7
  • Mark A Wingertzahn, M Jennifer Derebery, Harold S Nelson
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    ABSTRACT: Intranasal corticosteroids (INCSs) provide safe and effective treatment of allergic rhinitis (AR). Currently available INCSs differ in terms of the components included in each formulation that may influence efficacy, tolerability, and patient preference for treatment. Patient preference for a specific INCS is largely attributable to the sensory attributes that are dependent on characteristics of the formulation. Preservatives and additives can irritate and dry the mucosal membranes, or they can confer an unpleasant odor or taste to an INCS formulation. Spray volume also may affect patients' sensory perceptions of INCS formulations. Relative osmotic pressure or tonicity may affect nasal absorption and retention of an INCS and potentially affect clinical efficacy. A hypotonic suspension is a new formulation option for INCSs that may improve sensory attributes and has the potential to improve patient satisfaction and treatment outcomes in patients with AR. Optimization of INCS formulations may improve efficacy and tolerability and influence patient preference for treatment.
    Allergy and Asthma Proceedings 05/2007; 28 Suppl 1:S18-24. DOI:10.2500/aap.2007.28.2993 · 3.35 Impact Factor
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    ABSTRACT: Ciclesonide is an intranasal corticosteroid approved for the treatment of allergic rhinitis (AR). To evaluate the efficacy, safety, and quality-of-life benefits of intranasal ciclesonide, 200 microg once daily, for the treatment of perennial AR (PAR). In this multicenter, randomized, double-blind, placebo-controlled study, adults and adolescents with at least a 2-year history of PAR received intranasal ciclesonide, 200 microg, or placebo once daily for 6 weeks. Patient-evaluated total nasal symptom scores (TNSSs), physician-assessed overall nasal signs and symptoms severity scores, and Rhinoconjunctivitis Quality of Life Questionnaire scores were evaluated. Patient baseline characteristics were similar in the ciclesonide (n = 238) and placebo (n = 233) groups and were consistent with moderate PAR severity. Ciclesonide therapy significantly reduced average morning and evening reflective TNSSs compared with placebo (P < .001) and significantly reduced average morning and evening instantaneous TNSSs (P = .001) over 6 weeks of treatment. At the end point, a greater decrease from baseline was observed in physician-assessed overall nasal signs and symptoms severity for the ciclesonide group compared with the placebo group (P = .051). An appreciable improvement in combined Rhinoconjunctivitis Quality of Life Questionnaire scores at the end point was also observed in the ciclesonide group (P = .01 vs placebo). The frequency of adverse events was similar between treatment groups. In this study, intranasal ciclesonide treatment was associated with significant reductions in nasal symptoms and appreciable improvements in health-related quality of life in adult and adolescent patients with PAR. Ciclesonide was well tolerated, with a safety profile comparable with that of placebo.
    Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 02/2007; 98(2):175-81. DOI:10.1016/S1081-1206(10)60693-X · 2.75 Impact Factor
  • Journal of Allergy and Clinical Immunology 01/2007; 119(1). DOI:10.1016/j.jaci.2006.11.687 · 11.25 Impact Factor
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    ABSTRACT: Ciclesonide is an investigational corticosteroid under development for treatment of allergic rhinitis. Ciclesonide is converted to active metabolite, desisobutyryl-ciclesonide (des-CIC), by upper and lower airway esterases. In vitro studies in human nasal epithelial cells and bronchial epithelial cells have demonstrated a long duration of anti-inflammatory activity of des-CIC. To evaluate the dose-dependent efficacy and safety of a hypotonic intranasal formulation of ciclesonide in patients with seasonal allergic rhinitis (SAR). This was a phase 2, randomized, parallel-group, double-blind, placebo-controlled study. Adults (n = approximately 145 per treatment group) with a minimum 2-year history of SAR received placebo or ciclesonide (25, 50, 100, or 200 microg/d) for 14 days. The primary end point was change in the sum of morning and evening reflective total nasal symptom scores (TNSSs) over 2 weeks. Safety was monitored throughout the study. Ciclesonide, 100 microg/d (P = .04) and 200 microg/d (P = .003), significantly improved the sum of morning and evening reflective TNSS vs placebo at more than 2 weeks of treatment. Baseline values for morning and evening reflective TNSS ranged from 17.80 to 18.82 across treatment groups. The average change from baseline in reflective TNSS was -4.2 for placebo and -4.8, -4.8, -5.3, and -5.8 for ciclesonide, 25, 50, 100, and 200 microg/d, respectively. There were no dose-related differences in the incidence of adverse events among treatment groups. Results from this study indicate that 100-microg and 200-microg daily doses of ciclesonide are effective in the treatment of SAR. Ciclesonide, 200 microg/d, appears to be the optimal dose studied for reducing the symptoms of SAR while maintaining an acceptable safety profile.
    Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 12/2006; 97(5):657-63. DOI:10.1016/S1081-1206(10)61097-6 · 2.75 Impact Factor