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Shirley C. Chen - One of the best experts on this subject based on the ideXlab platform.
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effects of intranasal Xylometazoline alone or in combination with ipratropium in patients with common cold
Current Medical Research and Opinion, 2010Co-Authors: Ronald Eccles, Kaj Martensson, Shirley C. ChenAbstract:Background: Common cold is one of the most prevalent conditions that family doctors encounter. One of the first symptoms to occur is nasal congestion, which can have a negative impact on daily life and prompts many patients to seek treatment for relief. Xylometazoline nasal spray (Otrivin*) is a topical decongestant that has been used successfully for many years and is generally recognized as an effective and safe therapy. However, most studies have investigated its clinical efficacy in healthy patients and few have included patients with common cold. *Otrivin® is a registered trademark of Novartis AG, Basel, Switzerland. Scope: To review the published clinical efficacy and safety of Xylometazoline alone and in combination in the management of nasal congestion in patients with common cold. Literature searches of PubMed and the Cochrane Library were conducted to obtain published open or blinded, randomized, placebo- or active-controlled studies on the use of Xylometazoline hydrochloride for the symptomatic relief of nasal congestion in patients with common cold. Searches included papers published in English only, up to September 2009. Findings: Despite the small number of studies identified in common cold (n = 4), as per search criteria defined, intranasal Xylometazoline quickly and effectively relieved nasal congestion. When used alone, Xylometazoline had a clinically relevant decongestant effect that was significantly superior for up to 10 hours compared with placebo. The superior decongestant effect with Xylometazoline led to high patient satisfaction with treatment. When used in combination with ipratropium bromide, nasal congestion and rhinorrhoea were treated simultaneously, leading to significantly higher patient general impression scores compared with either agent used alone. Xylometazoline was well tolerated, with generally mild to moderate nasal-related side effects (e.g. epistaxis in 3.4% of patients, and blood-tinged mucus in 10–26% of patients) that were easily resolved; the most frequently reported non-nasal AEs were headache (3.4%) and period pain (10.3%); no cases of sedation were reported. As expected, no rhinitis medicamentosa or rebound congestion was noted with short-term use (<10 days). No clinically important differences in ciliary motility and mucociliary clearance were observed. Xylometazoline does not result in sympathomimetic systemic side effects seen with oral decongestants (e.g. pseudoephedrine, phenylephrine). Conclusions: The few studies available in common cold suggest that intranasal Xylometazoline provides fast and effective relief of nasal congestion and is well tolerated. When Xylometazoline is used in combination with ipratropium, patients with common cold experience the additive benefit of nasal congestion and rhinorrhoea being treated simultaneously.
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effects of intranasal Xylometazoline alone or in combination with ipratropium in patients with common cold
Current Medical Research and Opinion, 2010Co-Authors: Ronald Eccles, Kaj Martensson, Shirley C. ChenAbstract:AbstractBackground:Common cold is one of the most prevalent conditions that family doctors encounter. One of the first symptoms to occur is nasal congestion, which can have a negative impact on daily life and prompts many patients to seek treatment for relief. Xylometazoline nasal spray (Otrivin) is a topical decongestant that has been used successfully for many years and is generally recognized as an effective and safe therapy. However, most studies have investigated its clinical efficacy in healthy patients and few have included patients with common cold. * Otrivin® is a registered trademark of Novartis AG, Basel, Switzerland.Scope:To review the published clinical efficacy and safety of Xylometazoline alone and in combination in the management of nasal congestion in patients with common cold. Literature searches of PubMed and the Cochrane Library were conducted to obtain published open or blinded, randomized, placebo- or active-controlled studies on the use of Xylometazoline hydrochloride for the sympto...
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efficacy and safety of intranasal Xylometazoline and ipratropium in patients with common cold
Expert Opinion on Pharmacotherapy, 2009Co-Authors: P. Graf, Ronald Eccles, Shirley C. ChenAbstract:Background: Many over-the-counter medications are available to treat common cold nasal symptoms, but patients may be unsure which one to use. Methods: This review assesses two widely used intranasal treatments for nasal congestion and rhinorrhea in the common cold: Xylometazoline hydrochloride and ipratropium bromide. Results: Xylometazoline quickly and effectively relieves nasal congestion, while ipratropium is effective at reducing rhinorrhea. When used in combination, a novel approach to treatment, nasal congestion and rhinorrhea are treated simultaneously, providing effective relief from two of the most troublesome symptoms of the common cold Both drugs are well tolerated, with only mild to moderate, nasal-related side effects. Conclusions: The efficacy and safety of the combination product suggest that it should be used first-line in the symptomatic relief of nasal congestion and rhinorrhea, before the use of oral treatments.
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The Nasal Decongestant Effect of Xylometazoline in the Common Cold
American Journal of Rhinology, 2008Co-Authors: Ronald Eccles, Margareta Eriksson, Steve Garreffa, Shirley C. ChenAbstract:Background: Xylometazoline is a nasal decongestant spray that constricts nasal blood vessels and increases nasal airflow, enabling patients with a blocked nose to breathe more easily. The purpose of this study was to characterize objectively and subjectively the decongestant and additional effects of Xylometazoline in the common cold. Methods: A double-blind, placebo-controlled, parallel group study was performed. Patients with a common cold (n = 61) were treated with Xylometazoline 0.1% (n = 29) or placebo (saline solution; n = 32; 1 spray three times a day for up to 10 days). The primary objective was to determine the decongestant effect (nasal conductance); the secondary objectives were to determine the peak subjective effect (visual analog scale), duration of relief of nasal congestion, total and individual cold symptoms and general well-being (patients' daily diary), and adverse events (AEs). Results: The decongestant effect of Xylometazoline was significantly greater than placebo, as shown by the nasal conductance at 1 hour (384.23 versus 226.42 cm3/s; p ≤ 0.0001) and peak subjective effect (VAS, 20.7 mm versus 31.5 mm; p = 0.0298). Nasal conductance was significantly superior for up to 10 hours (p = 0.0009) and there was a trend in favor of Xylometazoline for up to 12 hours (not statistically significant). Xylometazoline significantly improved total and some individual common cold symptoms scores (p < 0.05), leading to significantly greater patient general evaluation and satisfaction with treatment (p < 0.05). Nineteen AEs were reported: 8 with Xylometazoline (all mild-moderate) and 11 with placebo (1 severe). Conclusion: Xylometazoline is an effective and well-tolerated decongestant nasal spray that significantly relieved nasal congestion compared with placebo in the common cold and provided long-lasting relief with just 1 spray, helping patients to breathe more easily for a longer period of time.
Ronald Eccles - One of the best experts on this subject based on the ideXlab platform.
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effects of intranasal Xylometazoline alone or in combination with ipratropium in patients with common cold
Current Medical Research and Opinion, 2010Co-Authors: Ronald Eccles, Kaj Martensson, Shirley C. ChenAbstract:AbstractBackground:Common cold is one of the most prevalent conditions that family doctors encounter. One of the first symptoms to occur is nasal congestion, which can have a negative impact on daily life and prompts many patients to seek treatment for relief. Xylometazoline nasal spray (Otrivin) is a topical decongestant that has been used successfully for many years and is generally recognized as an effective and safe therapy. However, most studies have investigated its clinical efficacy in healthy patients and few have included patients with common cold. * Otrivin® is a registered trademark of Novartis AG, Basel, Switzerland.Scope:To review the published clinical efficacy and safety of Xylometazoline alone and in combination in the management of nasal congestion in patients with common cold. Literature searches of PubMed and the Cochrane Library were conducted to obtain published open or blinded, randomized, placebo- or active-controlled studies on the use of Xylometazoline hydrochloride for the sympto...
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effects of intranasal Xylometazoline alone or in combination with ipratropium in patients with common cold
Current Medical Research and Opinion, 2010Co-Authors: Ronald Eccles, Kaj Martensson, Shirley C. ChenAbstract:Background: Common cold is one of the most prevalent conditions that family doctors encounter. One of the first symptoms to occur is nasal congestion, which can have a negative impact on daily life and prompts many patients to seek treatment for relief. Xylometazoline nasal spray (Otrivin*) is a topical decongestant that has been used successfully for many years and is generally recognized as an effective and safe therapy. However, most studies have investigated its clinical efficacy in healthy patients and few have included patients with common cold. *Otrivin® is a registered trademark of Novartis AG, Basel, Switzerland. Scope: To review the published clinical efficacy and safety of Xylometazoline alone and in combination in the management of nasal congestion in patients with common cold. Literature searches of PubMed and the Cochrane Library were conducted to obtain published open or blinded, randomized, placebo- or active-controlled studies on the use of Xylometazoline hydrochloride for the symptomatic relief of nasal congestion in patients with common cold. Searches included papers published in English only, up to September 2009. Findings: Despite the small number of studies identified in common cold (n = 4), as per search criteria defined, intranasal Xylometazoline quickly and effectively relieved nasal congestion. When used alone, Xylometazoline had a clinically relevant decongestant effect that was significantly superior for up to 10 hours compared with placebo. The superior decongestant effect with Xylometazoline led to high patient satisfaction with treatment. When used in combination with ipratropium bromide, nasal congestion and rhinorrhoea were treated simultaneously, leading to significantly higher patient general impression scores compared with either agent used alone. Xylometazoline was well tolerated, with generally mild to moderate nasal-related side effects (e.g. epistaxis in 3.4% of patients, and blood-tinged mucus in 10–26% of patients) that were easily resolved; the most frequently reported non-nasal AEs were headache (3.4%) and period pain (10.3%); no cases of sedation were reported. As expected, no rhinitis medicamentosa or rebound congestion was noted with short-term use (<10 days). No clinically important differences in ciliary motility and mucociliary clearance were observed. Xylometazoline does not result in sympathomimetic systemic side effects seen with oral decongestants (e.g. pseudoephedrine, phenylephrine). Conclusions: The few studies available in common cold suggest that intranasal Xylometazoline provides fast and effective relief of nasal congestion and is well tolerated. When Xylometazoline is used in combination with ipratropium, patients with common cold experience the additive benefit of nasal congestion and rhinorrhoea being treated simultaneously.
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efficacy and safety of intranasal Xylometazoline and ipratropium in patients with common cold
Expert Opinion on Pharmacotherapy, 2009Co-Authors: P. Graf, Ronald Eccles, Shirley C. ChenAbstract:Background: Many over-the-counter medications are available to treat common cold nasal symptoms, but patients may be unsure which one to use. Methods: This review assesses two widely used intranasal treatments for nasal congestion and rhinorrhea in the common cold: Xylometazoline hydrochloride and ipratropium bromide. Results: Xylometazoline quickly and effectively relieves nasal congestion, while ipratropium is effective at reducing rhinorrhea. When used in combination, a novel approach to treatment, nasal congestion and rhinorrhea are treated simultaneously, providing effective relief from two of the most troublesome symptoms of the common cold Both drugs are well tolerated, with only mild to moderate, nasal-related side effects. Conclusions: The efficacy and safety of the combination product suggest that it should be used first-line in the symptomatic relief of nasal congestion and rhinorrhea, before the use of oral treatments.
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The Nasal Decongestant Effect of Xylometazoline in the Common Cold
American Journal of Rhinology, 2008Co-Authors: Ronald Eccles, Margareta Eriksson, Steve Garreffa, Shirley C. ChenAbstract:Background: Xylometazoline is a nasal decongestant spray that constricts nasal blood vessels and increases nasal airflow, enabling patients with a blocked nose to breathe more easily. The purpose of this study was to characterize objectively and subjectively the decongestant and additional effects of Xylometazoline in the common cold. Methods: A double-blind, placebo-controlled, parallel group study was performed. Patients with a common cold (n = 61) were treated with Xylometazoline 0.1% (n = 29) or placebo (saline solution; n = 32; 1 spray three times a day for up to 10 days). The primary objective was to determine the decongestant effect (nasal conductance); the secondary objectives were to determine the peak subjective effect (visual analog scale), duration of relief of nasal congestion, total and individual cold symptoms and general well-being (patients' daily diary), and adverse events (AEs). Results: The decongestant effect of Xylometazoline was significantly greater than placebo, as shown by the nasal conductance at 1 hour (384.23 versus 226.42 cm3/s; p ≤ 0.0001) and peak subjective effect (VAS, 20.7 mm versus 31.5 mm; p = 0.0298). Nasal conductance was significantly superior for up to 10 hours (p = 0.0009) and there was a trend in favor of Xylometazoline for up to 12 hours (not statistically significant). Xylometazoline significantly improved total and some individual common cold symptoms scores (p < 0.05), leading to significantly greater patient general evaluation and satisfaction with treatment (p < 0.05). Nineteen AEs were reported: 8 with Xylometazoline (all mild-moderate) and 11 with placebo (1 severe). Conclusion: Xylometazoline is an effective and well-tolerated decongestant nasal spray that significantly relieved nasal congestion compared with placebo in the common cold and provided long-lasting relief with just 1 spray, helping patients to breathe more easily for a longer period of time.
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Efficacy and safety of topical combinations of ipratropium and Xylometazoline for the treatment of symptoms of runny nose and nasal congestion associated with acute upper respiratory tract infection.
American journal of rhinology, 2007Co-Authors: Ronald Eccles, Anette Pedersen, Dan Regberg, Heikki Tulento, Peter Borum, Pär StjärneAbstract:Background: Rhinorrhea and nasal congestion are simultaneous symptoms associated with the common cold. This study investigated the efficacy and safety of a combination nasal spray of ipratropium and Xylometazoline for simultaneous treatment of these symptoms. Methods: The trial was a multicenter double-blind, parallel-group, randomized design on patients with common cold symptoms. Patients scored symptoms of runny nose and nasal congestion and recorded adverse events in a diary for up to 7 days. Patients also recorded tissue use. The five test treatments consisted of ipratropium, 0.6 mg/mL, and Xylometazoline, 1.0 mg/mL; ipratropium, 0.6 mg/mL, and Xylometazoline, 0.5 mg/mL; ipratropium, 0.6 mg/mL; Xylometazoline, 1.0 mg/mL; and placebo solution. Results: Eight hundred sixty-four patients were screened and 786 patients received treatment. One day after treatment there was a clear separation between the scores for the placebo and ipratropium treatment groups for rhinorrhea and between the placebo and Xylometazoline treatment groups for congestion. Both ipratropium/Xylometazoline 1.0 and ipratropium/Xylometazoline 0.5 treatments were superior to Xylometazoline with respect to rhinorrhea (p < 0.0001) and superior to ipratropium with respect to nasal congestion scores (p < 0.001). Both the ipratropium combination treatments had significantly lower tissue use than the Xylometazoline treatment group (p < 0.0001). Adverse events were distributed equally between the treatments, except mucus tinged with blood, epistaxis, nasal passage irritation, and nasal dryness, which had a higher incidence in the three groups that received medicines containing ipratropium. Conclusion: The results indicate that a combination medicine of ipratropium and Xylometazoline is safe and effective for treatment of rhinorrhea and nasal congestion associated with common cold.
Halis H Unlu - One of the best experts on this subject based on the ideXlab platform.
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a comparative analysis of the decongestive effect of oxymetazoline and Xylometazoline in healthy subjects
European Journal of Clinical Pharmacology, 2011Co-Authors: Görkem Eskiizmir, Zafer Hircin, Beyhan Cengiz Ozyurt, Halis H UnluAbstract:Background Oxymetazoline and Xylometazoline are locally effective and direct acting drugs that relieve nasal congestion. The aim of this study was to objectively determine and compare the decongestive effects of oxymetazoline and Xylometazoline in healthy subjects.
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a comparative analysis of the decongestive effect of oxymetazoline and Xylometazoline in healthy subjects
European Journal of Clinical Pharmacology, 2011Co-Authors: Görkem Eskiizmir, Zafer Hircin, Beyhan Cengiz Ozyurt, Halis H UnluAbstract:Oxymetazoline and Xylometazoline are locally effective and direct acting drugs that relieve nasal congestion. The aim of this study was to objectively determine and compare the decongestive effects of oxymetazoline and Xylometazoline in healthy subjects. The study population comprised thirty healthy adults. All subjects underwent active anterior rhinomanometry (AARhm) and acoustic rhinometry (AR) tests following the application of oxymetazoline, Xylometazoline, or placebo (physiological saline). The change in nasal resistance, nasal airflow, and different cross-sectional areas (CSAs) of the nasal cavity in the subjects were examined for each solution separately. The measurements were obtained over a 1-h period (baseline and 1, 15, 30, and 60 min post-dosing). All results were analyzed using the Kruskal–Wallis test and the Mann–Whitney U test. A total of 6,300 measurements of AARhm and AR were obtained. The application of placebo did not cause a statistically significant change in nasal resistance, nasal airflow, and CSAs (CSA1, 2, and 3, respectively) of the nasal cavity. In contrast, statistically significant changes in nasal resistance (inspiration p = 0.000 and p = 0.004; expiration p = 0.000 and p = 0.000), nasal airflow (inspiration p = 0.000 and p = 0.004; expiration p = 0.000 and p = 0.000), and CSAs of the nasal cavity (CSA2 p = 0.000 and p = 0.000, CSA3 p = 0.000 and p = 0.00), with the exception of CSA1 (p = 0.982 and p = 0.994), were obtained after the application of oxymetazoline and Xylometazoline. A comparison of oxymetazoline and Xylometazoline based on nasal resistance, nasal airflow, and CSAs of the nasal cavity demonstrated no statistically significant difference, except for CSA3. Oxymetazoline and Xylometazoline are fast-acting and potent topical decongestants that have similar decongestive effects.
Tilman Keck - One of the best experts on this subject based on the ideXlab platform.
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Immediate effect of benzalkonium chloride in decongestant nasal spray on the human nasal mucosal temperature.
Clinical Otolaryngology, 2004Co-Authors: Jörg Lindemann, Richard Leiacker, Kerstin Wiesmiller, Gerhard Rettinger, Tilman KeckAbstract:: Benzalkonium chloride is a preservative commonly used in nasal decongestant sprays. It has been suggested that benzalkonium chloride may be harmful to the nasal mucosa. Decongestion with the vasoconstrictor Xylometazoline containing benzalkonium chloride has been shown to cause a significant reduction of the nasal mucosal temperature. The purpose of the present study was to determine the short-term influence of Xylometazoline nasal spray with and without benzalkonium chloride on the nasal mucosal temperature. Healthy volunteers (30) were included in the study. Fifteen volunteers received Xylometazoline nasal spray (1.0 mg/mL) containing benzalkonium chloride (0.1 mg/mL) and 15 age-matched subjects, received Xylometazoline nasal spray without benzalkonium chloride. Using a miniaturized thermocouple the septal mucosal temperature was continuously measured at defined intranasal detection sites before and after application of the nasal spray. The mucosal temperature values did not significantly differ between the group receiving Xylometazoline containing benzalkonium chloride and the group receiving Xylometazoline spray without benzalkonium chloride before and after decongestion (P > 0.05). In both study groups septal mucosal temperatures significantly decreased after decongestion (P < 0.05) because of a reduction of the nasal mucosal blood flow following vasoconstriction. This study indicates that benzalkonium chloride itself does not seem to influence nasal blood flow and nasal mucosal temperature in topical nasal decongestants.
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the effect of topical Xylometazoline on the mucosal temperature of the nasal septum
American Journal of Rhinology, 2002Co-Authors: Jörg Lindemann, Richard Leiacker, Gerhard Rettinger, Tilman KeckAbstract:BACKGROUND The purpose of this study was to determine the short-term influence of the alpha2-adrenoreceptor agonist Xylometazoline on the nasal mucosal temperature. METHODS Thirty healthy subjects were enrolled into the study. Fifteen of these subjects got Xylometazoline and 15 subjects, matched to age, got saline solution as control. A miniaturized thermocouple was used for continuous detection of the septal mucosal temperature without interruption of nasal breathing before and after application of nose spray. RESULTS In the anterior nasal segment, the mucosal temperatures before decongestion were significantly higher than after decongestion (p < 0.05). These changes could not be found in the control group after saline solution. The mean end-expiratory mucosal temperatures were significantly higher than the end-inspiratory ones in both study groups (p < 0.005). CONCLUSIONS The reduction of the nasal mucosal bloodflow because of vasoconstriction and the increase of the nasal cavity volume after decongestion with Xylometazoline seem to cause a significant decrease of the septal mucosal temperature in the anterior nasal segment. This might be one possible causative factor of the common symptom of the "dry nose" in patients with nasal decongestant abuse.
Martina Morokuttikurz - One of the best experts on this subject based on the ideXlab platform.
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development of a nasal spray containing Xylometazoline hydrochloride and iota carrageenan for the symptomatic relief of nasal congestion caused by rhinitis and sinusitis
International Journal of General Medicine, 2018Co-Authors: Christine Graf, Eva Prieschlgrassauer, Andreas Bernkopschnurch, Alena Egyed, Christiane Koller, Martina MorokuttikurzAbstract:Introduction Xylometazoline hydrochloride (HCl) is a nasal decongestant that causes vasoconstriction in the nasal submucosa. It has been used for more than 50 years for the treatment of nasal congestion caused by rhinitis/sinusitis. Iota-carrageenan is effective against a broad variety of respiratory viruses, which are the most common cause of infections of the upper respiratory tract. Therefore, it is used as the active component in the antiviral nasal spray Coldamaris prophylactic (1.2 mg/mL iota-carrageenan in 0.5% NaCl) and other medical device nasal sprays that are approved and marketed in the EU. Recently, we developed a nasal spray formulation containing both Xylometazoline HCl (0.05%) and iota-carrageenan (0.12%) that provides decongestion and antiviral protection of the nasal mucosa at the same time. Results A set of in vitro experiments revealed that the vasoconstrictive properties of Xylometazoline HCl and the antiviral effectiveness of iota-carrageenan against human rhinovirus (hRV) 1a, hRV8 and human coronavirus OC43 were maintained in the formulation containing these two compounds. Permeation experiments using bovine nasal mucosa showed that iota-carrageenan had no significant influence on the permeation of Xylometazoline HCl. Finally, in the local tolerance and toxicity study, it was shown that the formulation was well tolerated at the application site with no occurrence of erythema or edema in the nostrils of all rabbits or any signs of toxicity in any of the organs and tissues inspected. Conclusion Investigations on compatibility of Xylometazoline HCl and iota-carrageenan demonstrated that the substances do not influence each other, allowing both to fulfill their known specific clinical efficacy (Xylometazoline HCl) and effectiveness (iota-carrageenan).
