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Claus Bachert - One of the best experts on this subject based on the ideXlab platform.
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A new allergic rhinitis therapy (MP29-02*) provides effective and rapid symptom relief for patients who suffer most from the bothersome symptoms of Nasal Congestion or ocular itch
Clinical and Translational Allergy, 2015Co-Authors: Wytske J. Fokkens, Joaquim Mullol, Peter Hellings, Ullrich Munzel, Claus BachertAbstract:Background Allergic rhinitis (AR) patients often present with a predominant symptom. Nasal Congestion and ocular symptoms have the greatest negative impact on patients’ quality of life [1]. Our aim was to assess the efficacy of MP29-02* (a novel intraNasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP] in an advanced delivery system) in seasonal AR (SAR) patients presenting with Nasal Congestion or ocular itch predominantly compared to AZE, FP or placebo (PLA) Nasal sprays.
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a new allergic rhinitis therapy mp29 02 provides effective and rapid symptom relief for patients who suffer most from the bothersome symptoms of Nasal Congestion or ocular itch
Clinical and Translational Allergy, 2015Co-Authors: W J Fokkens, Peter Hellings, Joaquim Mullol, Ullrich Munzel, Claus BachertAbstract:Background Allergic rhinitis (AR) patients often present with a predominant symptom. Nasal Congestion and ocular symptoms have the greatest negative impact on patients’ quality of life [1]. Our aim was to assess the efficacy of MP29-02* (a novel intraNasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP] in an advanced delivery system) in seasonal AR (SAR) patients presenting with Nasal Congestion or ocular itch predominantly compared to AZE, FP or placebo (PLA) Nasal sprays.
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Pathophysiology of Nasal Congestion.
International journal of general medicine, 2010Co-Authors: Robert M. Naclerio, Claus Bachert, James N. BaraniukAbstract:Nasal Congestion is a common symptom in rhinitis (both allergic and nonallergic), rhinosinusitis and Nasal polyposis. Congestion can also be caused by physical obstruction of Nasal passages and/or modulation of sensory perception. Mucosal inflammation underlies many of the specific and interrelated factors that contribute to Nasal Congestion, as well as other symptoms of both allergic rhinitis and rhinosinusitis. A wide range of biologically active agents (eg, histamine, tumor necrosis factor-α, interleukins, cell adhesion molecules) and cell types contribute to inflammation, which can manifest as venous engorgement, increased Nasal secretions and tissue swelling/edema, ultimately leading to impaired airflow and the sensation of Nasal Congestion. Inflammation-induced changes in the properties of sensory afferents (eg, expression of peptides and receptors) that innervate the nose can also contribute to altered sensory perception, which may result in a subjective feeling of Congestion. Increased understanding of the mechanisms underlying inflammation can facilitate improved treatment selection and the development of new therapies for Congestion.
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a review of the efficacy of desloratadine fexofenadine and levocetirizine in the treatment of Nasal Congestion in patients with allergic rhinitis
Clinical Therapeutics, 2009Co-Authors: Claus BachertAbstract:Abstract Background: Nasal Congestion is the most troublesome symptom of allergic rhinitis (AR). First-generation and older second-generation antihistamines, while effective against Nasal itching, sneezing, and rhinorrhea, have limited efficacy in relieving Nasal Congestion. Objective: This review included Nasal challenge studies and clinical trials that reported the effects on Nasal Congestion of the newer second-generation antihista-mines desloratadine, fexofenadine, and levocetirizine. Methods: MEDLINE and EMBASE were searched for Nasal challenge studies and clinical trials published in English between January 1, 1991, and January 31, 2009, using the following terms, alone or in combination: antihistamines, second-generation antihistamines, allergic rhinitis, intermittent allergic rhinitis, perennial allergic rhinitis, persistent allergic rhinitis, seasonal allergic rhinitis, Nasal challenge, Nasal blockage, and Nasal Congestion. Studies that were not active or placebo controlled, that did not evaluate change in Nasal Congestion scores, or that focused on treatments other than desloratadine, fexofenadine, and levoce-tirizine for Nasal Congestion associated with AR were excluded. Results: Twenty-six clinical trials met the criteria for inclusion in the review. In 11 placebo-controlled trials that included objective assessment of Nasal Congestion, desloratadine, fexofenadine, and levocetiri-zine were associated with reductions in the severity of Nasal Congestion through maintenance of Nasal airflow. The mean AUC for Nasal airflow over 6 hours was significantly greater with desloratadine compared with placebo in 3 studies ( P P ≤ 0.05), beginning as early as the first 2 hours after allergen challenge. Fexofenadine was associated with significantly lower Nasal Congestion scores compared with placebo in 4 studies ( P P ≤ 0.005). Conclusions: In the studies reviewed, desloratadine, fexofenadine, and levocetirizine were effective in relieving the Nasal Congestion associated with AR compared with placebo. This effect began as early as day 2 and was consistent and progressive throughout treatment. Desloratadine, fexofenadine, and levocetirizine are appropriate options for the treatment of Nasal Congestion in patients with AR.
Eli O. Meltzer - One of the best experts on this subject based on the ideXlab platform.
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Phenylephrine hydrochloride modified-release tablets for Nasal Congestion: a randomized, placebo-controlled trial in allergic rhinitis patients
Annals of allergy asthma & immunology : official publication of the American College of Allergy Asthma & Immunology, 2015Co-Authors: Eli O. Meltzer, Paul H Ratner, Thomas McgrawAbstract:Abstract Background Over-the-counter phenylephrine hydrochloride (PEH) is used for relief of Nasal Congestion caused by allergic rhinitis; however, data to support its efficacy are lacking. The US Food and Drug Administration recommended clinical trials to evaluate the efficacy and safety of PEH in patients with this condition. Objective To evaluate the efficacy and safety of PEH 30-mg modified-release (MR) tablets in patients with Nasal Congestion caused by allergic rhinitis in a multicenter, randomized, double-blinded, placebo-controlled, 2-arm, parallel-group study. Methods Eligible adults at least 18 years old with documented hypersensitivity to fall pollen allergens were randomized to PEH-MR or placebo every 12 hours for 7 days from August 30 to October 12, 2011. The primary end point was mean change from baseline during the entire treatment period in daily reflective Nasal Congestion score. Secondary end points included changes in other symptom score assessments, time to maximal effect, duration of effect, and quality of life. Safety assessments included adverse events, serious adverse events, vital signs, physical examination, and electrocardiograms. Results Of 575 patients, 288 received PEH-MR and 287 received placebo. No significant beneficial difference was detected between PEH-MR and placebo for the primary end point (PEH-MR, mean −0.394, SD 0.4880; placebo, mean −0.412, SD 0.5383; P = .2655). Likewise, no significant differences were observed for most secondary end points or quality of life. Overall, 89 of 575 patients (15.5%), equally distributed between the PEH-MR and placebo groups, experienced at least 1 treatment-emergency adverse event. Conclusion PEH-MR 30-mg tablets taken orally every 12 hours for 7 days is not more efficacious than placebo in relieving Nasal Congestion caused by allergic rhinitis. Trial Registration: clinicaltrials.gov, identifier NCT01413958, protocol CL2011-06.
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Objective and subjective responses to a mechanical external Nasal dilator in healthy children and children with Nasal Congestion.
Allergy and asthma proceedings, 2015Co-Authors: Eli O. Meltzer, Steven M. JohnsonAbstract:BACKGROUND Nasal Congestion is a frequent symptom of allergic rhinitis. Mechanical external Nasal dilators (MEND) can be applied to the outside of the nose to provide temporary relief from Nasal stuffiness. OBJECTIVE To assess the objective and subjective benefits and tolerability of MEND in healthy children and in children with Nasal Congestion due to allergic rhinitis. METHODS Two studies were performed, one in healthy children and one in children with Nasal Congestion. The study of healthy children was a single-center, randomized, crossover study of two pediatric MEND variants, "tan" and "stars." The study of children with Nasal Congestion was a single-center assessment of the stars MEND. In both studies, Nasal patency was measured via peak Nasal inspiratory flow in the seated position and in the supine position at baseline and after the pediatric MEND was affixed to the nose. Assessment questions were administered at baseline and after MEND application, while seated and while supine, to evaluate subjective reduction in Nasal blockage and tolerability. RESULTS Thirty healthy and 26 children with Nasal Congestion were assessed. Pediatric MENDs showed a statistically significant improvement in peak Nasal inspiratory flow for both healthy children and children with Nasal Congestion while seated and for healthy children while recumbent. Pediatric MENDs were perceived as decreasing Nasal obstruction in both healthy children and children with Nasal Congestion in both positions, and there were statistically significant improvements in most subjective measures. Pediatric MENDs were well tolerated. CONCLUSIONS Pediatric MENDs provided significant objective increases in Nasal patency in healthy children and children with Nasal Congestion in the seated position and also subjective reduction in Nasal airway stuffiness in both seated and supine positions; they were also well tolerated.
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oral phenylephrine hcl for Nasal Congestion in seasonal allergic rhinitis a randomized open label placebo controlled study
The Journal of Allergy and Clinical Immunology: In Practice, 2015Co-Authors: Eli O. Meltzer, Paul H Ratner, Thomas McgrawAbstract:Background Phenylephrine hydrochloride (PE HCl) is widely used for the treatment of Nasal Congestion, but efficacy at the 10-mg dose is not known for certain. The Food and Drug Administration has requested that sufficiently powered, multicenter, dose-ranging studies be conducted to assess the efficacy and safety of PE HCl. Objective To evaluate subjective Nasal Congestion symptom relief and safety of 4 different doses of PE HCl immediate-release 10-mg tablets and placebo in adults with seasonal allergic rhinitis (SAR). Methods This multicenter, phase 2, parallel, open-label trial randomized 539 adults with SAR (but otherwise healthy) to 7 days of treatment with either PE HCl 10-mg tablets at fixed doses of 10, 20, 30, or 40 mg or placebo. The primary efficacy end point was the mean change from baseline over the entire treatment period in daily reflective Nasal Congestion score. Other efficacy end points and safety were also evaluated. Results None of the PE HCl treatment groups had a statistically significant change from baseline in instantaneous or reflective Nasal Congestion scores compared with the placebo group. PE HCl was well tolerated at doses of up to 30 mg. At least 1 treatment-emergent adverse event was experienced by 18.4% of the participants, the most common being headache (3.0%). Conclusions PE HCl, at doses of up to 40 mg every 4 hours, is not significantly better than placebo at relieving Nasal Congestion in adults with SAR. The phenylephrine section of the Food and Drug Administration monograph on over-the-counter cold, cough, allergy, bronchodilator, and antiasthmatic products should be revised accordingly.
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Relieving Nasal Congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate Nasal spray.
The World Allergy Organization journal, 2013Co-Authors: Eli O. Meltzer, Davis Gates, Carlos E. Baena-cagnani, Ariel TeperAbstract:Background In surveys of children with allergic rhinitis (AR), Nasal Congestion has been identified as the most frequently experienced and bothersome symptom. This analysis was conducted to investigate the effect of mometasone furoate Nasal spray (MFNS) on Congestion in children with AR.
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Mometasone furoate Nasal spray for moderate-to-severe Nasal Congestion in subjects with seasonal allergic rhinitis.
Allergy and asthma proceedings, 2011Co-Authors: Eli O. Meltzer, Tulin Shekar, Ariel TeperAbstract:Nasal Congestion is a frequent, bothersome symptom of seasonal allergic rhinitis (SAR). Mometasone furoate Nasal spray (MFNS) has established efficacy in treating Nasal allergy symptoms, but no study has been conducted with the primary purpose of evaluating MFNS for relief of Congestion. This study assessed MFNS for Congestion and other Nasal symptoms in SAR. Two double-blind, placebo-controlled studies randomized symptomatic SAR patients to 15 days of MFNS, 200 micrograms, or placebo q.d. each morning. Participants scored individual components of total Nasal symptom score (TNSS; Congestion, rhinorrhea, sneezing, and itching) on a 4-point scale in the morning (A.M.) and evening (P.M.). Symptoms were scored for the time of assessment (NOW) and for the previous 12 hours (PRIOR). The pooled population comprised 684 patients randomized to MFNS (n = 344) or placebo (n = 340). Change from baseline in A.M./P.M. PRIOR Nasal Congestion score averaged over days 1-15, the primary end point, was significantly (p < 0.001) greater with MFNS than with placebo (0.68-point [25.2%] reduction versus 0.45-point [16.0%] reduction, respectively). Reduction in A.M./P.M. PRIOR TNSS averaged over days 1-15, a key secondary end point, was also superior with MFNS (2.83 points [28.5%] versus 1.79 points [17.6%]; p < 0.001). Predose A.M. NOW Congestion, other Nasal symptoms, and TNSS improved significantly more with MFNS, indicating 24-hour efficacy. Adverse events were infrequent and localized; the most common (epistaxis and pharyngolaryngeal pain) occurred in 1.0% of MFNS patients. MFNS q.d. provides sustained relief for Nasal Congestion and other SAR symptoms.
Wytske J. Fokkens - One of the best experts on this subject based on the ideXlab platform.
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A new allergic rhinitis therapy (MP29-02*) provides effective and rapid symptom relief for patients who suffer most from the bothersome symptoms of Nasal Congestion or ocular itch
Clinical and Translational Allergy, 2015Co-Authors: Wytske J. Fokkens, Joaquim Mullol, Peter Hellings, Ullrich Munzel, Claus BachertAbstract:Background Allergic rhinitis (AR) patients often present with a predominant symptom. Nasal Congestion and ocular symptoms have the greatest negative impact on patients’ quality of life [1]. Our aim was to assess the efficacy of MP29-02* (a novel intraNasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP] in an advanced delivery system) in seasonal AR (SAR) patients presenting with Nasal Congestion or ocular itch predominantly compared to AZE, FP or placebo (PLA) Nasal sprays.
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Diagnostic strategies in Nasal Congestion.
International journal of general medicine, 2010Co-Authors: John H. Krouse, Wytske J. Fokkens, Valerie J. Lund, Eli O. MeltzerAbstract:Nasal Congestion is a major symptom of upper respiratory tract disorders, and its characterization an important part of the diagnosis of these illnesses. Patient history and assessment of Nasal symptoms are essential components of diagnosis, providing an initial evaluation that may be adequate to rule out serious conditions. However, current Congestion medications are not always fully effective. Thus, if symptoms do not respond adequately to therapy, or symptoms suggestive of more serious conditions are present, specialized assessments may be needed. Various techniques are available for diagnosing patients, including those used chiefly by primary care clinicians and those requiring the expertise of otolaryngologists, allergists, and other specialists. Endoscopy remains a mainstay for evaluating Nasal blockage and its causes, while modalities such as peak Nasal inspiratory flow and acoustic rhinometry are evolving to provide easy-to-use, noninvasive procedures that are sensitive enough to measure small but clinically important abnormalities and therapeutic changes. Several imaging modalities are available to the specialist for severe or unusual cases, as are specialized diagnostic procedures that measure adjunctive features of Congestion, such as impaired mucociliary function.
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Evidence-based recommendations regarding the differential diagnosis and assessment of Nasal Congestion: using the new GRADE system.
Allergy, 2008Co-Authors: E. Van Spronsen, Koen J. A. O. Ingels, A.p.h. Jansen, Kees Graamans, Wytske J. FokkensAbstract:Nasal Congestion is an important symptom in Nasal pathology and can be defined as an objective restriction of Nasal cavity airflow because of mucosal pathology and/or increased mucus secretion (excluding anatomical variants). Using the new Grading Recommendations Assessment, Development and Evaluation system, evidence-based recommendations are made that will encompass different clinical questions regarding diagnostic modalities of Nasal Congestion: (i) their usefulness in assessment of presence and severity of Congestion; (ii) their usefulness in assessment of etiological pathology responsible for Congestion; and (iii) their usefulness in follow up and treatment effectiveness evaluation of Nasal Congestion.
Joaquim Mullol - One of the best experts on this subject based on the ideXlab platform.
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a new allergic rhinitis therapy mp29 02 provides effective and rapid symptom relief for patients who suffer most from the bothersome symptoms of Nasal Congestion or ocular itch
Clinical and Translational Allergy, 2015Co-Authors: W J Fokkens, Peter Hellings, Joaquim Mullol, Ullrich Munzel, Claus BachertAbstract:Background Allergic rhinitis (AR) patients often present with a predominant symptom. Nasal Congestion and ocular symptoms have the greatest negative impact on patients’ quality of life [1]. Our aim was to assess the efficacy of MP29-02* (a novel intraNasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP] in an advanced delivery system) in seasonal AR (SAR) patients presenting with Nasal Congestion or ocular itch predominantly compared to AZE, FP or placebo (PLA) Nasal sprays.
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A new allergic rhinitis therapy (MP29-02*) provides effective and rapid symptom relief for patients who suffer most from the bothersome symptoms of Nasal Congestion or ocular itch
Clinical and Translational Allergy, 2015Co-Authors: Wytske J. Fokkens, Joaquim Mullol, Peter Hellings, Ullrich Munzel, Claus BachertAbstract:Background Allergic rhinitis (AR) patients often present with a predominant symptom. Nasal Congestion and ocular symptoms have the greatest negative impact on patients’ quality of life [1]. Our aim was to assess the efficacy of MP29-02* (a novel intraNasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP] in an advanced delivery system) in seasonal AR (SAR) patients presenting with Nasal Congestion or ocular itch predominantly compared to AZE, FP or placebo (PLA) Nasal sprays.
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Oral plus Nasal corticosteroids improve smell, Nasal Congestion, and inflammation in sino-Nasal polyposis
The Laryngoscope, 2013Co-Authors: Isam Alobid, Pedro Benítez, Sara Cardelús, Francisco De Borja Callejas, Eduardo Lehrer-coriat, Laura Pujols, César Picado, Joaquim MullolAbstract:Objectives/Hypothesis To assess the effect of oral plus intraNasal corticosteroids on subjective outcomes (smell and Nasal Congestion) and objective outcomes (tissue eosinophilia and nitric oxide) in severe Nasal polyposis (NP). Study Design After a 4-week steroid washout period (w0), severe NP were randomized into a treatment group (n = 67) that receive oral prednisone for 2 weeks (w2) plus intraNasal budesonide for 12 weeks (w12), and a control group (n = 22) that received no steroid treatment. Methods Barcelona Smell Test 24 (BAST-24), Nasal Congestion, tissue eosinophilia, and Nasal nitric oxide (nNO) were assessed. Results Before treatment, patients showed a significant impairment of smell detection (30.7 ± 39.5%), identification (7.1 ± 16.1%), and forced choice (13.8 ± 23.3%) in BAST-24 compared to healthy population. At w2, the treatment group showed a significant improvement in detection, identification, and forced choice. Positive effect was also seen after 12 weeks of intraNasal corticosteroids. A significant reduction of Nasal Congestion (1.17 ± 1.0 vs. 2.73 ± 0.5) and polyp tissue eosinophilia (10.9 ± 4.2 vs. 41.2 ± 12.2) with an increase of nNO (650 ± 317 vs. 420 ± 221 ppb) were observed at w2 compared to w0 and to the control group. These effects were also seen at w12. Conclusions Combined oral and intraNasal corticosteroids improve smell and Nasal Congestion and decrease Nasal inflammation, as measured by reduced tissue eosinophilia and increased detection of nNO. Severity of smell loss correlates with degree of Nasal Congestion but not with inflammation, as measured by tissue eosinophilia or Nasally exhaled nNO. Our findings suggest that improvement in smell may be related to improved conduction of odorants to the olfactory neuroepithelium. Level of Evidence Ib. Laryngoscope, 124:50–56, 2014
Ariel Teper - One of the best experts on this subject based on the ideXlab platform.
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Relieving Nasal Congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate Nasal spray.
The World Allergy Organization journal, 2013Co-Authors: Eli O. Meltzer, Davis Gates, Carlos E. Baena-cagnani, Ariel TeperAbstract:Background In surveys of children with allergic rhinitis (AR), Nasal Congestion has been identified as the most frequently experienced and bothersome symptom. This analysis was conducted to investigate the effect of mometasone furoate Nasal spray (MFNS) on Congestion in children with AR.
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Mometasone furoate Nasal spray for moderate-to-severe Nasal Congestion in subjects with seasonal allergic rhinitis.
Allergy and asthma proceedings, 2011Co-Authors: Eli O. Meltzer, Tulin Shekar, Ariel TeperAbstract:Nasal Congestion is a frequent, bothersome symptom of seasonal allergic rhinitis (SAR). Mometasone furoate Nasal spray (MFNS) has established efficacy in treating Nasal allergy symptoms, but no study has been conducted with the primary purpose of evaluating MFNS for relief of Congestion. This study assessed MFNS for Congestion and other Nasal symptoms in SAR. Two double-blind, placebo-controlled studies randomized symptomatic SAR patients to 15 days of MFNS, 200 micrograms, or placebo q.d. each morning. Participants scored individual components of total Nasal symptom score (TNSS; Congestion, rhinorrhea, sneezing, and itching) on a 4-point scale in the morning (A.M.) and evening (P.M.). Symptoms were scored for the time of assessment (NOW) and for the previous 12 hours (PRIOR). The pooled population comprised 684 patients randomized to MFNS (n = 344) or placebo (n = 340). Change from baseline in A.M./P.M. PRIOR Nasal Congestion score averaged over days 1-15, the primary end point, was significantly (p < 0.001) greater with MFNS than with placebo (0.68-point [25.2%] reduction versus 0.45-point [16.0%] reduction, respectively). Reduction in A.M./P.M. PRIOR TNSS averaged over days 1-15, a key secondary end point, was also superior with MFNS (2.83 points [28.5%] versus 1.79 points [17.6%]; p < 0.001). Predose A.M. NOW Congestion, other Nasal symptoms, and TNSS improved significantly more with MFNS, indicating 24-hour efficacy. Adverse events were infrequent and localized; the most common (epistaxis and pharyngolaryngeal pain) occurred in 1.0% of MFNS patients. MFNS q.d. provides sustained relief for Nasal Congestion and other SAR symptoms.
