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P. Graf - One of the best experts on this subject based on the ideXlab platform.
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Benzalkonium chloride as a preservative in nasal solutions: re-examining the data.
Respiratory medicine, 2001Co-Authors: P. GrafAbstract:Recent studies have suggested that benzalkonium chloride (BKC), an antimicrobial agent used as a preservative in nasal sprays, lacks deleterious effects on the nasal ciliated epithelium. Other data, including recent in vivo findings, suggest that BKC may, in fact, produce adverse clinical effects on human nasal tissue, including the aggravation of Rhinitis medicamentosa. Toxic effects have also been reported. In light of the discrepancy between negative results and studies suggesting no safety concerns, we consider the possibility of problems in the design and methodology of some of the studies and in the interpretation of results. Clearly, further research is warranted to clarify the significance of conflicting findings. In the meantime, without conclusive data regarding BKC and the possibility of harmful effects, the use of nasal formulations without BKC might be a reasonable alternative.
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Adverse effects of benzalkonium chloride on the nasal mucosa: allergic Rhinitis and Rhinitis medicamentosa.
Clinical therapeutics, 1999Co-Authors: P. GrafAbstract:Prolonged, repeated use of nasal decongestants for symptomatic relief of allergic Rhinitis often results in Rhinitis medicamentosa (RM), a condition involving "rebound swelling" and additional congestion. Most decongestant sprays contain the preservative benzalkonium chloride (BKC), which causes toxic reactions in the nose, eyes, ears, and lungs, and may exacerbate the symptoms of allergic Rhinitis. Recent studies demonstrate the effects of nasal sprays containing BKC or the decongestant oxymetazoline (OXY) in the development of RM. Using rhinostereometry, a technique that measures nasal mucosal swelling and nasal reactivity (with histamine challenge tests), prolonged use of OXY has been shown to induce nasal mucosal swelling and hyperreactivity. Sustained use of BKC alone induces nasal mucosal swelling and, in combination with OXY, BKC appears to have a long-term adverse effect on nasal mucosa. Its presence may also contribute to the RM resulting from overuse of decongestant sprays. Additional research is needed to confirm the deleterious effects of BKC in nasal products. However, these potential effects may be points of clinical differentiation in the treatment of allergic Rhinitis and prevention of RM.
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Changes in Nasal Reactivity in Patients with Rhinitis medicamentosa after Treatment with Fluticasone Propionate and Placebo Nasal Spray
ORL; journal for oto-rhino-laryngology and its related specialties, 1998Co-Authors: P. Graf, H. HallénAbstract:Aim of the Study: To study the changes in nasal reactivity in patients with Rhinitis medicamentosa during treatment with placebo or fluticasone propionate, in order to better unders
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Fluticasone propionate nasal spray is more effective and has a faster onset of action than placebo in treatment of Rhinitis medicamentosa
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1997Co-Authors: H. Hallén, J. Enerdal, P. GrafAbstract:Summary Background Controversy still exists about the treatment of Rhinitis medicamentosa and treatment has never been objectively evaluated. Objective To study the effect of fluticasone propionate aqueous nasal spray compared to placebo nasal spray in the treatment of Rhinitis medicamentosa. Methods A parallel randomized, double-blind study was conducted to evaluate the treatment of Rhinitis medicamentosa. Two groups containing 10 patients with Rhinitis medicamentosa in each group stopped their overuse of nasal vasoconstrictor spray immediately and were treated with either fluticasone propionate nasal spray once daily 200 mg, or placebo nasal spray for 14 days. The nasal mucosal swelling was recorded with rhinostereometry, acoustic rhinometry and a peak inspiratory flow meter. Nasal stuffiness was estimated on a visual analogue scale in the morning and in the evening of each day. Results The mucosal swelling decreased after 7 and 14 days of treatment with fluticasone propionate as well as placebo, but the reduction was significantly greater after treatment with fluticasone propionate. The symptom scores for nasal stuffiness showed a marked reduction during the treatment period in both groups, but there was a faster onset of symptom reduction after treatment with fluticasone propionate. Conclusion Fluticasone propionate is more effective and has a faster onset of action than placebo in the treatment of Rhinitis medicamentosa. An adequate treatment of these patients consists of a combination of vasoconstrictor withdrawal and a topical corticosteroid to alleviate the withdrawal process.
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One-week use of oxymetazoline nasal spray in patients with Rhinitis medicamentosa 1 year after treatment.
ORL; journal for oto-rhino-laryngology and its related specialties, 1997Co-Authors: P. Graf, H. HallénAbstract:The aim of the present study was to investigate whether patients with Rhinitis medicamentosa who stopped using the topical vasoconstrictors may use these drugs again more than 1 year later. Eight pati
Janerik Juto - One of the best experts on this subject based on the ideXlab platform.
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Kinetic oscillation stimulation as treatment of non-allergic Rhinitis: an RCT study.
Acta oto-laryngologica, 2014Co-Authors: Janerik Juto, Maria AxelssonAbstract:Abstract Conclusion: Kinetic oscillation stimulation (KOS) of nasal mucosa at low frequency seems to be a possibly effective and safe short-term treatment of non-allergic nasal stuffiness. Objective: To assess the relief of Rhinitis symptoms, especially stuffiness, by comparing active treatment, i.e. KOS at low frequency of the nasal mucosa, with placebo. Methods: Patients were randomized to active or placebo treatment in this double-blinded parallel design study. Treatment with an inflatable oscillating catheter was administered on day 0, and symptom scores (stuffiness, secretion, and itching) were graded daily until day 14. An overall grading of symptoms from 1 week before treatment and during 14 days thereafter was made at day 14. Eighty-six patients (52 with non-allergic perennial Rhinitis, NAR; 34 with Rhinitis medicamentosa, RM) were randomized, and 71 were evaluated (active treatment, n = 35; placebo, n = 36). Results: Patients with either NAR or RM who received active treatment reported reduced sy...
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ORIGINAL ARTICLE Kinetic oscillation stimulation as treatment of non-allergic Rhinitis: an RCT study
2014Co-Authors: Janerik Juto, Maria AxelssonAbstract:Conclusion: Kinetic oscillation stimulation (KOS) of nasal mucosa at low frequency seems to be a possibly effective and safe short-term treatment of non-allergic nasal stuffiness.Objective:To assess the relief of Rhinitis symptoms, especially stuffiness, by comparing active treatment, i.e. KOS at low frequency of the nasal mucosa, with placebo.Methods: Patients were randomized to active or placebo treatment in this double-blinded parallel design study. Treatment with an inflatable oscillating catheter was administered on day 0, and symptom scores (stuffiness, secretion, and itching) were graded daily until day 14. An overall grading of symptoms from 1 week before treatment and during 14 days thereafter was made at day 14. Eighty-six patients (52 with non-allergic perennial Rhinitis, NAR; 34 with Rhinitis medicamentosa, RM) were randomized, and 71 were evaluated (active treatment, n = 35; placebo, n = 36). Results: Patients with either NAR or RM who received active treatment reported reduced symptom scores by some measures, e.g. median RQSS stuffiness measure fell from 2 to 1 on a scale from 0 to 3 during the week following treatment. No significant effect was observed for patients treated with placebo. Mild side effects were reported
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Benzalkonium chloride in a decongestant nasal spray aggravates Rhinitis medicamentosa in healthy volunteers.
Clinical & Experimental Allergy, 1995Co-Authors: Janerik JutoAbstract:Summary A randomized double-blind parallel study with 20 healthy volunteers was performed to research the effect of a preservative in a decongestant nasal spray on the development of Rhinitis medicamentosa. Ten subjects received oxymetazoline nasal spray with benzalkonium chloride and the others used oxymetazoline nasal spray without the preservative three times daily for 30 days. Before starting the course of treatment and after its conclusion, recordings of the mucosal surface positions were made with rhinostereometry followed by histamine challenge tests. Symptoms of nasal stuffiness were estimated on visual analogue scales (0–100) in the morning and the evening just before using the nasal spray. After 30 days, rebound swelling and nasal stuffiness were found in both groups. In the group receiving oxymetazoline nasal spray with benzalkonium chloride the mean rebound swelling was 1.1 mm and the estimated mean evening symptom score for nasal stuffiness was 43. In the group without benzalkonium chloride the corresponding variables were significantly less marked, with a mean rebound swelling of 0.5 mm (P
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benzalkonium chloride in a decongestant nasal spray aggravates Rhinitis medicamentosa in healthy volunteers
Clinical & Experimental Allergy, 1995Co-Authors: P. Graf, H. Hallén, Janerik JutoAbstract:Summary A randomized double-blind parallel study with 20 healthy volunteers was performed to research the effect of a preservative in a decongestant nasal spray on the development of Rhinitis medicamentosa. Ten subjects received oxymetazoline nasal spray with benzalkonium chloride and the others used oxymetazoline nasal spray without the preservative three times daily for 30 days. Before starting the course of treatment and after its conclusion, recordings of the mucosal surface positions were made with rhinostereometry followed by histamine challenge tests. Symptoms of nasal stuffiness were estimated on visual analogue scales (0–100) in the morning and the evening just before using the nasal spray. After 30 days, rebound swelling and nasal stuffiness were found in both groups. In the group receiving oxymetazoline nasal spray with benzalkonium chloride the mean rebound swelling was 1.1 mm and the estimated mean evening symptom score for nasal stuffiness was 43. In the group without benzalkonium chloride the corresponding variables were significantly less marked, with a mean rebound swelling of 0.5 mm (P<0.05) and a mean evening symptom score of 25 (P<0.05). The increase in histamine sensitivity in both groups was interpreted as a sign of nasal hyperreactivity. A new type of nasal spray bottle was used that has been shown to prevent bacterial contamination. In conclusion, the long-term use of benzalkonium chloride in oxymetazoline nasal spray accentuates the severity of Rhinitis medicamentosa in healthy volunteers.
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four week use of oxymetazoline nasal spray nezeril once daily at night induces rebound swelling and nasal hyperreactivity
Acta Oto-laryngologica, 1995Co-Authors: P. Graf, Hans Hallen, Janerik JutoAbstract:A randomized double-blind parallel study with 20 healthy volunteers was performed to examine the effect of oxymetazoline nasal spray on the development of Rhinitis medicamentosa. For 30 days, 10 subjects were given oxymetazoline nasal spray once daily at night and placebo in the morning and at noon, while the others used oxymetazoline nasal spray three times daily. Before and after the course of treatment, the mucosal surface positions were determined with rhinostereome-try, followed by histamine challenge tests. In the morning and the evening just before use of the nasal spray, symptoms of nasal stuffiness were evaluated on visual analogue scales (0 100). After 30 days, rebound swelling and nasal stuffiness were found in both groups. In the group receiving oxymetazoline nasal spray once daily at night, the mean rebound swelling was 0.8 mm (p <0.01) and the estimated mean symptom score for nasal stuffiness in the evening was 43 (p <0.05). In the group receiving the same nasal spray three times daily, the ...
H. Hallén - One of the best experts on this subject based on the ideXlab platform.
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Changes in Nasal Reactivity in Patients with Rhinitis medicamentosa after Treatment with Fluticasone Propionate and Placebo Nasal Spray
ORL; journal for oto-rhino-laryngology and its related specialties, 1998Co-Authors: P. Graf, H. HallénAbstract:Aim of the Study: To study the changes in nasal reactivity in patients with Rhinitis medicamentosa during treatment with placebo or fluticasone propionate, in order to better unders
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Fluticasone propionate nasal spray is more effective and has a faster onset of action than placebo in treatment of Rhinitis medicamentosa
Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology, 1997Co-Authors: H. Hallén, J. Enerdal, P. GrafAbstract:Summary Background Controversy still exists about the treatment of Rhinitis medicamentosa and treatment has never been objectively evaluated. Objective To study the effect of fluticasone propionate aqueous nasal spray compared to placebo nasal spray in the treatment of Rhinitis medicamentosa. Methods A parallel randomized, double-blind study was conducted to evaluate the treatment of Rhinitis medicamentosa. Two groups containing 10 patients with Rhinitis medicamentosa in each group stopped their overuse of nasal vasoconstrictor spray immediately and were treated with either fluticasone propionate nasal spray once daily 200 mg, or placebo nasal spray for 14 days. The nasal mucosal swelling was recorded with rhinostereometry, acoustic rhinometry and a peak inspiratory flow meter. Nasal stuffiness was estimated on a visual analogue scale in the morning and in the evening of each day. Results The mucosal swelling decreased after 7 and 14 days of treatment with fluticasone propionate as well as placebo, but the reduction was significantly greater after treatment with fluticasone propionate. The symptom scores for nasal stuffiness showed a marked reduction during the treatment period in both groups, but there was a faster onset of symptom reduction after treatment with fluticasone propionate. Conclusion Fluticasone propionate is more effective and has a faster onset of action than placebo in the treatment of Rhinitis medicamentosa. An adequate treatment of these patients consists of a combination of vasoconstrictor withdrawal and a topical corticosteroid to alleviate the withdrawal process.
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One-week use of oxymetazoline nasal spray in patients with Rhinitis medicamentosa 1 year after treatment.
ORL; journal for oto-rhino-laryngology and its related specialties, 1997Co-Authors: P. Graf, H. HallénAbstract:The aim of the present study was to investigate whether patients with Rhinitis medicamentosa who stopped using the topical vasoconstrictors may use these drugs again more than 1 year later. Eight pati
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One Year Follow-Up of Patients With Rhinitis medicamentosa After Vasoconstrictor Withdrawal
American journal of rhinology, 1997Co-Authors: P. Graf, H. HallénAbstract:The aim of the study was to systematically follow-up 10 patients with Rhinitis medicamentosa for at least 1 year after vasoconstrictor withdrawal. During withdrawal of the decongestants the patients used budesonide nasal spray, 400 micrograms/day, for 6 weeks. The thickness of the nasal mucosa, the decongestive effect of oxymetazoline, and the histamine sensitivity were measured with rhinostereometry during the period. The thickness of the nasal mucosa and the symptom scores of nasal stuffiness were reduced considerably 6 and 12 months after vasoconstrictor withdrawal. The histamine sensitivity reflecting nasal hyperreactivity was still increased after 6 months, but not after 1 year. The decongestive effect of oxymetazoline increased after 6 months, indicating reversible tolerance. We conclude that when given adequate treatment and information about nose-drop overuse, all patients were able to stop using the vasoconstrictors and no one relapsed into a daily long-term overuse of vasoconstrictors during the 1-year follow-up period.
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Effect on the Nasal Mucosa of Long‐Term Treatment With Oxymetazoline, Benzalkonium Chloride, and Placebo Nasal Sprays
The Laryngoscope, 1996Co-Authors: P. Graf, H. HallénAbstract:A parallel, randomized, double-blind study was performed in 30 healthy subjects to investigate the effects on the nasal mucosa of a 1-month treatment with nasal sprays. Ten subjects received oxymetazoline nasal spray; 10 subjects used a nasal spray containing the preservative benzalkonium chloride, and the others were treated with a placebo nasal spray. The three variables that were studied --nasal mucosal swelling, symptom scores, and nasal reactivity-- were estimated by histamine challenge before and after 28 days of treatment. Rhinostereometry was used to measure nasal mucosal swelling and nasal reactivity. After 28 days of use, benzalkonium chloride spray alone induced an increase in nasal mucosal swelling. At the end of the month, the score for nasal stuffiness was significantly higher for the group treated with oxymetazoline than for those treated with benzalkonium chloride. Oxymetazoline nasal spray induced a pronounced increase in nasal reactivity, which was significantly greater than that induced in the placebo group. Long-term use of placebo and benzalkonium chloride nasal sprays also caused an increase in nasal reactivity, but not to the same extent as with the nasal sprays containing oxymetazoline. The authors concluded that long-term use of oxymetazoline induces a sensation of nasal stuffiness, which may be due to unconscious exaggeration of the degree of nasal stuffiness, induced nasal hyperreactivity, or a combination of both. These factors are probably the main reasons for the prolonged use of nasal decongestive sprays and the development of Rhinitis medicamentosa. Benzalkonium chloride induces mucosal swelling, which explains why the presence of this preservative in a decongestant spray aggravates Rhinitis medicamentosa.
J. E. Juto - One of the best experts on this subject based on the ideXlab platform.
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Four-week use of oxymetazoline nasal spray (Nezeril) once daily at night induces rebound swelling and nasal hyperreactivity.
Acta oto-laryngologica, 1995Co-Authors: P. Graf, H. Hallén, J. E. JutoAbstract:A randomized double-blind parallel study with 20 healthy volunteers was performed to examine the effect of oxymetazoline nasal spray on the development of Rhinitis medicamentosa. For 30 days, 10 subjects were given oxymetazoline nasal spray once daily at night and placebo in the morning and at noon, while the others used oxymetazoline nasal spray three times daily. Before and after the course of treatment, the mucosal surface positions were determined with rhinostereome-try, followed by histamine challenge tests. In the morning and the evening just before use of the nasal spray, symptoms of nasal stuffiness were evaluated on visual analogue scales (0 100). After 30 days, rebound swelling and nasal stuffiness were found in both groups. In the group receiving oxymetazoline nasal spray once daily at night, the mean rebound swelling was 0.8 mm (p
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Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling.
Rhinology, 1995Co-Authors: P. Graf, J. E. JutoAbstract:Long-term use of topical vasoconstrictors for the nose may result in Rhinitis medicamentosa, drug addiction and tachyphylaxis. Some authors also believe that the severity of rebound swelling is proportional to the period during which the drug has been used, the frequency of its administration, and the amount of drug given. It has previously been reported that four-week use of the recommended dose of oxymetazoline induces rebound swelling, a sign of Rhinitis medicamentosa. To study the effect of an increased amount of vasoconstrictor on rebound swelling and the decongestive effect of the drug, nine healthy subjects were given xylometazoline nasal spray in double the recommended dose (1.0 mg/ml; 0.28 ml in each nostril thrice daily) for 30 days. After 30 days on xylometazoline, the decongestive effect was the same 1 h after drug administration as before starting the medication. Similarly, after 30 days on xylometazoline, the decongestive effect was less 5 h after drug administration than it was 6 h after drug administration at the start of medication (p < 0.005). After 10 days no rebound swelling was recorded, but after 30 days rebound swelling occurred in eight out of nine subjects (p < 0.05). When comparing the results of this trial with the corresponding results of the oxymetazoline study, no further increase in rebound swelling was found. We conclude that long-term use of xylometazoline nasal spray shortens the decongestive response in healthy volunteers. Moreover, double the recommended dose of xylometazoline did not further increase the rebound swelling seen when using the recommended dose of oxymetazoline.
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Histamine Sensitivity in the Nasal Mucosa during Long-term Use of Xylometazoline in the Doubled Recommended Dose
American Journal of Rhinology, 1994Co-Authors: P. Graf, J. E. JutoAbstract:It has been suggested that the severity of Rhinitis medicamentosa is dependent on the length of time the drug has been used, on how frequently it is used, and on the amount administered. It has bee...
Hans Hallen - One of the best experts on this subject based on the ideXlab platform.
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Acoustic rhinometer Nasal reactivity
2015Co-Authors: Peter M. Graf, Hans Hallen, Fluticasone PropionateAbstract:Aim of the Study: To study the changes in nasal reactivity in patients with Rhinitis medicamentosa during treatment with placebo or fluticasone propio-nate, in order to better understand the mechanisms of nasal congestion in such patients. Study Design: A parallel, double-blind study. Twenty patients with Rhinitis medicamentosa were randomized to either placebo or fluticasone treatment during 14 days. Material and Methods: Nasal mucosa reactivity was studied with a histamine challenge model using three concentrations of histamine to challenge the nasal mucosa (1, 2 and 4 mg histamine/ml). Recordings of the nasal mucosa response were made 5 min after each chal-lenge, using rhinostereometry and acoustic rhinometry, before and after the period of treatment. Results: The fluticasone group had a significantly increased histamine sensitivity after treatment, unlike the placebo group who had an unchanged or slightly decreased histamine sensitivity after treatment. Conclusions: The results of this study support the theory that the nasal obstruction in Rhinitis medicamentosa is due to interstitial oedema rather than to vasodilatation. On the first day of vasoconstrictor withdrawal, the inferior concha was congested and oedematous with a limited capacity to respond to histamine challenge. However, after 14 days of treatment with a corticosteroid nasal spray, the oedema was reduced and the increase in histamine sensitivity reflected the persistence of nasal hyperrreactivity. In the placebo group, hista-mine sensitivity remains unchanged with the measuring technique we used. This probably indicates that oedema was still present after treatment. OOOOOOOOOOOOOOOOOOOOO
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effect on the nasal mucosa of long term treatment with oxymetazoline benzalkonium chloride and placebo nasal sprays
Laryngoscope, 1996Co-Authors: P. Graf, Hans HallenAbstract:A parallel, randomized, double-blind study was performed in 30 healthy subjects to investigate the effects on the nasal mucosa of a 1-month treatment with nasal sprays. Ten subjects received oxymetazoline nasal spray; 10 subjects used a nasal spray containing the preservative benzalkonium chloride, and the others were treated with a placebo nasal spray. The three variables that were studied --nasal mucosal swelling, symptom scores, and nasal reactivity-- were estimated by histamine challenge before and after 28 days of treatment. Rhinostereometry was used to measure nasal mucosal swelling and nasal reactivity. After 28 days of use, benzalkonium chloride spray alone induced an increase in nasal mucosal swelling. At the end of the month, the score for nasal stuffiness was significantly higher for the group treated with oxymetazoline than for those treated with benzalkonium chloride. Oxymetazoline nasal spray induced a pronounced increase in nasal reactivity, which was significantly greater than that induced in the placebo group. Long-term use of placebo and benzalkonium chloride nasal sprays also caused an increase in nasal reactivity, but not to the same extent as with the nasal sprays containing oxymetazoline. The authors concluded that long-term use of oxymetazoline induces a sensation of nasal stuffiness, which may be due to unconscious exaggeration of the degree of nasal stuffiness, induced nasal hyperreactivity, or a combination of both. These factors are probably the main reasons for the prolonged use of nasal decongestive sprays and the development of Rhinitis medicamentosa. Benzalkonium chloride induces mucosal swelling, which explains why the presence of this preservative in a decongestant spray aggravates Rhinitis medicamentosa.
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four week use of oxymetazoline nasal spray nezeril once daily at night induces rebound swelling and nasal hyperreactivity
Acta Oto-laryngologica, 1995Co-Authors: P. Graf, Hans Hallen, Janerik JutoAbstract:A randomized double-blind parallel study with 20 healthy volunteers was performed to examine the effect of oxymetazoline nasal spray on the development of Rhinitis medicamentosa. For 30 days, 10 subjects were given oxymetazoline nasal spray once daily at night and placebo in the morning and at noon, while the others used oxymetazoline nasal spray three times daily. Before and after the course of treatment, the mucosal surface positions were determined with rhinostereome-try, followed by histamine challenge tests. In the morning and the evening just before use of the nasal spray, symptoms of nasal stuffiness were evaluated on visual analogue scales (0 100). After 30 days, rebound swelling and nasal stuffiness were found in both groups. In the group receiving oxymetazoline nasal spray once daily at night, the mean rebound swelling was 0.8 mm (p <0.01) and the estimated mean symptom score for nasal stuffiness in the evening was 43 (p <0.05). In the group receiving the same nasal spray three times daily, the ...