K Hörmann1, A Plenker2, C Bachert3, B Hauswald4, L Klimek 5, G Rasp6 , C. Rudack 7, J Spaeth8, R Mösges9 1University Hospital Mannheim, Department of Otorhinolaryngology, Head and Neck Surgery, Mannheim, Germany, 2Essex Pharma GmbH, Munich Germany, 3University Hospital, Ghent, Belgium, 4University Hospital Dresden, Department of Otorhinolaryngology, Head and Neck Surgery, Dresden, Germany, 5Rhinologic Center, Wiesbaden, Germany, 6University Hospital Munich, Department of Otorhinolaryngology, Head and Neck Surgery, Munich, Germany, 7University Hospital Münster, Department of Otorhinolaryngology, Head and Neck Surgery, Münster, Germany, 8Private practice, Düren, Germany, 9University of Cologne, Institute of Medical Statistics, Informatics and Epidemiology, Cologne, Germany Introduction
Study design
• Sinusitis is a frequent disease with an increasing prevalence. In Germany chronic sinusitis has been diagnosed 2.6 million times within a one- year period (July 2000 until This was a phase-III, randomized, placebo-controlled, double-blind, parallel -group, multicenter clinical trial in 60 patients. The study protocol was approved of by independent ethics committees. All patients were required to give their informed consent • It has been proven in a recent study that a monotherapy with a topically applied corticosteroid (budesonide aqueous nasal spray) is efficacious in the treatment of chronic sinusitis.7 Patients with the clinical diagnosis of a chronic sinusitis and a positive CT-scan (Lund-Scale 2- 10) with an opacification of at least one osteomeatal complex and a moderate • Mometasone furoate nasal spray (MFNS) is being investigated for the treatment of or severe nasal obstruction were randomized to receive either MFNS solution (200 mcg chronic sinusitis. In clinical trials, topically applied nasal s teroids have been shown to be BID) or placebo for a study period of 112 days. Patients were required to visit the physician six times over the study period.
• the treatment of allergic rhinitis.
• In previous studies corticosteroids, in particular MFNS, have been proven to be efficacious as an adjunctive treatment to antibiotics in patients with acute sinusitis.6 Between April and September 2003, 60 patients (30 per group) with a history of chronic sinusitis for at least 3 months up to 35 years were randomized to treatment. The • A comparison of several intranasal steroids concedes that mometasone furoate has intention-to-treat population consisted of 45 patients; the per -protocol population the lowest systemic availability. 3, 4, 5 Less than 0.1 % of the dose is absorbed into the Endpoints
The primary efficacy endpoint was the change from baseline in the all day sum score
To evaluate the efficacy and safety of 200 mcg BID mometasone furoate nasal spray of the Total Sinusitis Symptom Score (TSS) as recorded in the patient diaries over the
(MFNS) in the treatment of chronic sinusitis as compared to placebo.
112 days of treatment. The baseline TSS was defined as the sum of the a.m. and the p.m. score on Day 1, prior to taking the first dose of study medication The patients used a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). The single symptoms assessed were: Analysis
• anterior rhinorrhea• postnasal drip according top the intention-to-treat-principle. A complementary analysis was perfomed on the per -protocol -population for the main endpoint only. Treatment groups were compared with respect to the baseline TSS using the Wilcoxon-Mann- Withney test, and also with respect to the secondaryendpoints at baseline using the adequate tests respectively. Secondary efficacy parameters
• Individual symptoms and global evaluation of sinusitis
• Endoscopical appearance score of the sinusitis
• Rhinosinusitis Disability Index Questionaire (RSDI)
• Work productivity and activity impairment questionaire• Satisfactionquestionaire Both treatment groups were comparable at inclusion in terms of their demographic parameters and at baseline also comparable in terms of their symptoms and theirbaseline TSS. The patients had a mean treatment lenght of 113.2 days, no patient Safetyand tolerabilitycriteria
was treated for fewer than 101 days over the 4 month study period. Patients applied a mean of 60 % of the medication foreseen b y the protocol .
• Vital signs and change in weight• Laboratory tests p < 0.05
p < 0.1
Figure 3: Patients rating of satisfaction after
Figure 5: Would you recommend thismedication ?
completion of the trial
p < 0.1
p < 0.05
Figure 4: Investigators rating of efficacy
Figure 1: Improvement of sinusitissymptoms during therapy. Change frombaseline in the all day sumscore of theTSS (p = 0,51).
Figure 6: Would you agree to take thismedication
p < 0.01
p < 0.01
Figure 2: Nasal endoscopical findings
The tolerability of the medication was excellent. One patient in each group left the study This is the first long -term study on the use of mometasone furoate nasal spray in due to an adverse event: pruritus in the verum group and epistaxis in the placebo patients with CT- documented chronic sinusitis. During the course of symptoms over group. The most frequently observed AE was epistaxis, which at 10% fell into the four months of treatment, a clear numerical superiority of the nasal spray containing expected range and occurred at almost the same rate under verum and placebo.
the active ingredient can be noted which also reaches statistical significance on individual days. That this concerns clinically relevant advantag es is reflected in the positive final assessment made by the patients treated with MFNS. Affrime MB, Kosoglou T, Thonoor CM, Flannery BE, Herron JM. Mometasone furoatehas minimal effects on the hypothalamic -pituitary- adrenal axis when delivered at high doses. Chest (United States) 2000;118(6):1538-46.
Affrime MB, Cuss F, Padhi D, Wirth M, P a i S, Clement RP, Lim J, Kantesaria B, Alton K, C a y e n MN. Bioavailability and metabolism of mometasone furoate following administration by metered -dose and dry- powder inhalers in healthy human volunteers. J Clin Pharmacol (United States) 2000;40(11 ):1227-36.
Brannan MD, Herron JM, Affrime MB. Safety and tolerability of once -daily mometasone furoateaqueous nasal spray in children. Clin Ther (United States) 1997;19(6):1330 -9.
Brannan MD, Herron JM, Reidenberg P, Affrime MB. Lack of HPA Axis Suppression Following 36 Days of Intranasal Mometasone Furoate . Ann Allergy Asthma Immunol 1997;78:154.
Brannan MD, Seiberling M, Cutler DL, et al. Lack of Systemic Activity with Intranasal Mometasone Furoate. J Allergy Clin Immunol 1996;97:198.
Meltzer EO, et al. Added relief in the treatment of the acute recurrent sinusitis with adjunctive mometasone furoate nasal spray. J Allergy Clin Immunol 2000;106(4):630 -637.
LundV, Black SA, Szabó LZ, Schrewelius C , ÅkerlundA . Budesonide Aqueous Nasal Spray (BANS: Rhinocort® AquaTM) is Effective as Monotherapy i n Stable Patients w i t h Chronic Rhinosinusitis (CRS). Presented at the 58th Annual Meeting of t h e American Academy of A l l e r g y, Asthma and Immunology (AAAAI), New York, 1st -6th M a r c h 2002.


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