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Results of a comparative trial measuring rate of symptom relief in patients with acute bacterial sinusitis
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Abstracts
86 IsBudesonide Aqueous Nasal Spray (BANS: Rhinocort~ AquaTM) Effective as Monotherapy in Stable Patients With Chronic Rhinosinusitis(CRS) V Lund*, S Black§, Zs Ldszl6~, C Schrewelius~, A t~ker/und~ *Royal National Throat, Nose and Ear Hospital, London, UK §Port Elizabeth Center of ENT, Port Elizabeth, South Africa ¥3HIETE FiJl-Orr-Grgrszeti Clinic, Budapest, Hungary CAstraZeneca Lund, Lund, Sweden The objective of this study was to compare the efficacy of Rhinocort ® Aqua TM 128 ~g bid with placebo (PL) in patients with symptoms of CRS stable enough not to require antibiotics. One hundred and sixty-seven patients (aged >18 years) with CRS (symptoms present for >12 weeks) were randomized to 20 weeks of treatment in a double-blind manner with BANS 128/.tg or PL. Ninety-eight patients were judged as non-atopic (negative skin-prick test) and 69 as atopic. Antibiotic therapy was administered during the first 2 weeks of the 3-week run-in period. Additional antibiotic therapy was given during the treatment period only if exacerbations occurred, as judged by the investigator. BANS was administered as 64/.tg per nostril, twice daily. Efficacy was determined from combined symptom scores (CSS: 0-3 each for facial pain, nasal blockage, nasal discharge, impaired sense of smell), measurements of individual peak nasal inspiratory flow (PNIF), and the health-related quality of life (HRQL) questionnaire SF-36. BANS improved CSS significantly more than PL (morning reduction 1.85 vs 1.02, p=0.005; evening reduction 1.78 vs 1.02. p=0.012, respectively). During the study PNIF increased by a mean of 49.1 1/min in the BANS group compared with 10.4 l/min in the PL group (p<0.001). There was also a significant improvement in the general health domain of the HRQL questionnaire (p<0.04) in the BANS-treated patients compared with the PL group. The number of exacerbations was low in both groups (BANS, 1.3; PL, 1.1) and the proportion of antibiotic-free days was not significantly different (BANS, 92.3%; PL, 94.6%; p=0.61). In conclusion Rhinocort ®Aqua TM was efficacious as monotherapy in the treatment of stable adult chronic rhinosinusitis, providing significant benefits in terms of symptoms, PNIF and HRQL improvements compared with placebo.
'7 373 Patients With Sinus Pain/Pressure and Upper Respiratory 8Q g.ll/Symptoms-A Migraine Variant Syndrome Results of a New Management Strategy
M Lazarovich*, M Roznowski§, M Abrahamowicz¥ *National Sinus Research Center, Berlin, VT §Szpital im Jozefa Dietla, Krakow, Poland ~q)ivision of Clinical Epidemiology, Montreal General Hospital, Montreal, PQ Allergists are often the last resort of patients with chronic sinus pain/pressure and upper respiratory symptoms. Clinical observations and literature review led to a hypothesis of a neuroimmunological mechanism being responsible for the syndrome with histamine as one of the major mediators. A low impact (low probability of side effects) treatment protocol was designed accordingly. We present data on 373 patients managed over a 5-year period. Patients did not have CT scan evidence of significant sinusitis to explain self reported symptom (Bergner et al, Abstract 126). Management consisted of daily non-sedating antihistamine, unscented intranasal steroid and vitamin B2. Low dose (10-30 mg) amitryptiline was added in a group of patients with significant insomnia. Patients were asked to stop all caffeine, chocolate and sugar substitutes, drink a minimum of 2 liters of fluids per day and eat a minimum of 3 meals. The average baseline frequency of headache-days per month was 20.58. On follow up visit the average number of headaches per month was 4.31 (average reduction of 16.27 headache-days per month, p<0.0001). Over 90% of patients reported a significant reduction in the frequency of headaches (50% or better) while more than 60% of patients reported a complete resolution of symptoms. Patients with clinical allergy symptoms and corresponding positive skin tests (62.08%) were asked to implement environmental modifications when indicated. Allergic and non-allergic patients were managed with identical pharmacotherapy. There were no significant differences in response rates
J ALLERGY CLIN IMMUNOL JANUARY 2002
between the allergic and non-allergic patients. Histamine appears to be a mediator in allergic and non-allergic individuals. We propose that sinus pain/pressure with upper respiratory symptoms is a neuroimmunologicaly mediated migraine variant syndrome with significant genetic predisposition and a variety of internal and external trigger factors including allergens, non-specific organic irritants, ingestible neuroactive substances, hormonal changes, dehydration and hypoglycemia. The great majority of patients can be successfully managed with low impact pharmacotherapy and dietary modifications. A prospective, parallel group, double blind, placebo controlled study is planned.
8QQ Results of a Comparative Trial Measuring Rate of Symptom L I I U Relief in Patients With Acute Bacterial Sinusitis Gavin Corcoran*, James F Lawless§, Daniel Haverstock*, Cheryl Pause*, Miriam Faruqi*, Deborah Church* *Bayer Corporation, West Haven, CT §F F M Clinical Research, Camillus, NY BACKGROUND: Acute bacterial sinusitis (ABS) affects more than 30 million individuals each year in the United States and is associated with substantial patient morbidity. In a recent 1-year study, 26.7 million physician visits were attributable to sinusitis and related airway disorders. Additionally, the symptoms experienced by sinusitis patients result in a considerable negative effect on quality of life. METHODS: Patients diagnosed with ABS were enrolled in this multicenter, randomized, open label, three arm clinical trial. Patients received treatment for 10 days with one of the following regimens: moxifloxacin (MXF) 400 mg PO QD, levofloxacin (LEV) 500 mg PO QD, or amoxicillin clavulanate (AMC) 875/125 mg PO BID. Sinusitis symptom improvement was assessed on a daily basis using the Sino-Nasal Outcomes Test-16 (SNOT-16). Also, the rate of callbacks to the physician's office was measured through 14 days after therapy and the reason for the callback was recorded. All patients receiving at least one dose of study drug comprised the intent-to-treat (ITT) population. RESULTS: Within a subset of 746 patients in the ITT population, 715 (96%) had completed SNOT- 16 assessments at pre-treatment and day 3. Of these 715 patients, 45% (104/233) of MXF-, 42% (102/242) of LEV- and 40% (97/240) of AMC-treated patients reported symptomatic relief by day 3 of therapy. Differences between groups did not reach statistical significance. For the 746 ITT patients, the rates of patients making callbacks attributed to lack of symptom relief were 7% (18/247) of MXF-, 11% (28/248) of LEV-, and 13% (32/251) of AMC-treated patients. CONCLUSION: The rates of symptom relief observed in this study suggest that MXF-treated patients "feel better faster" than LEV- and AMCtreated patients and, in addition, may have less need to contact their physician's office. With clinical equivalence often established between comparator drugs, other outcome measures become increasingly relevant. The implications of faster symptom relief as provided by MXF treatment may positively influence patient quality of life, well-being, and productivity.
889
Health Demographicsof ObstructiveAirway Disease in the Disadvantaged Elderly of Chicago
D Abraham, LC Grammer, CA Saltoun, P Yarnold, A Malik Northwestern University Medical School, Chicago, IL BACKGROUND: Asthma is a common, chronic respiratory disease often described in younger age groups. However. it is common in the elderly as well and is often underdiagnosed. A particular subset of elderly often not represented are the economically disadvantaged. OBJECTIVE: The objective of this cross-sectional study was to describe the differences in a variety of health demographics and quality of life measurements between the disadvantaged elderly with doctor diagnosed asthma and those without diagnosed asthma. METHODS: The research subjects were recruited from 3 city subsidized facilities for the elderly. The research subjects agreed to complete a questionnaire about their health. They received a $10 gift certificate to a
Abstracts
86 IsBudesonide Aqueous Nasal Spray (BANS: Rhinocort~ AquaTM) Effective as Monotherapy in Stable Patients With Chronic Rhinosinusitis(CRS) V Lund*, S Black§, Zs Ldszl6~, C Schrewelius~, A t~ker/und~ *Royal National Throat, Nose and Ear Hospital, London, UK §Port Elizabeth Center of ENT, Port Elizabeth, South Africa ¥3HIETE FiJl-Orr-Grgrszeti Clinic, Budapest, Hungary CAstraZeneca Lund, Lund, Sweden The objective of this study was to compare the efficacy of Rhinocort ® Aqua TM 128 ~g bid with placebo (PL) in patients with symptoms of CRS stable enough not to require antibiotics. One hundred and sixty-seven patients (aged >18 years) with CRS (symptoms present for >12 weeks) were randomized to 20 weeks of treatment in a double-blind manner with BANS 128/.tg or PL. Ninety-eight patients were judged as non-atopic (negative skin-prick test) and 69 as atopic. Antibiotic therapy was administered during the first 2 weeks of the 3-week run-in period. Additional antibiotic therapy was given during the treatment period only if exacerbations occurred, as judged by the investigator. BANS was administered as 64/.tg per nostril, twice daily. Efficacy was determined from combined symptom scores (CSS: 0-3 each for facial pain, nasal blockage, nasal discharge, impaired sense of smell), measurements of individual peak nasal inspiratory flow (PNIF), and the health-related quality of life (HRQL) questionnaire SF-36. BANS improved CSS significantly more than PL (morning reduction 1.85 vs 1.02, p=0.005; evening reduction 1.78 vs 1.02. p=0.012, respectively). During the study PNIF increased by a mean of 49.1 1/min in the BANS group compared with 10.4 l/min in the PL group (p<0.001). There was also a significant improvement in the general health domain of the HRQL questionnaire (p<0.04) in the BANS-treated patients compared with the PL group. The number of exacerbations was low in both groups (BANS, 1.3; PL, 1.1) and the proportion of antibiotic-free days was not significantly different (BANS, 92.3%; PL, 94.6%; p=0.61). In conclusion Rhinocort ®Aqua TM was efficacious as monotherapy in the treatment of stable adult chronic rhinosinusitis, providing significant benefits in terms of symptoms, PNIF and HRQL improvements compared with placebo.
'7 373 Patients With Sinus Pain/Pressure and Upper Respiratory 8Q g.ll/Symptoms-A Migraine Variant Syndrome Results of a New Management Strategy
M Lazarovich*, M Roznowski§, M Abrahamowicz¥ *National Sinus Research Center, Berlin, VT §Szpital im Jozefa Dietla, Krakow, Poland ~q)ivision of Clinical Epidemiology, Montreal General Hospital, Montreal, PQ Allergists are often the last resort of patients with chronic sinus pain/pressure and upper respiratory symptoms. Clinical observations and literature review led to a hypothesis of a neuroimmunological mechanism being responsible for the syndrome with histamine as one of the major mediators. A low impact (low probability of side effects) treatment protocol was designed accordingly. We present data on 373 patients managed over a 5-year period. Patients did not have CT scan evidence of significant sinusitis to explain self reported symptom (Bergner et al, Abstract 126). Management consisted of daily non-sedating antihistamine, unscented intranasal steroid and vitamin B2. Low dose (10-30 mg) amitryptiline was added in a group of patients with significant insomnia. Patients were asked to stop all caffeine, chocolate and sugar substitutes, drink a minimum of 2 liters of fluids per day and eat a minimum of 3 meals. The average baseline frequency of headache-days per month was 20.58. On follow up visit the average number of headaches per month was 4.31 (average reduction of 16.27 headache-days per month, p<0.0001). Over 90% of patients reported a significant reduction in the frequency of headaches (50% or better) while more than 60% of patients reported a complete resolution of symptoms. Patients with clinical allergy symptoms and corresponding positive skin tests (62.08%) were asked to implement environmental modifications when indicated. Allergic and non-allergic patients were managed with identical pharmacotherapy. There were no significant differences in response rates
J ALLERGY CLIN IMMUNOL JANUARY 2002
between the allergic and non-allergic patients. Histamine appears to be a mediator in allergic and non-allergic individuals. We propose that sinus pain/pressure with upper respiratory symptoms is a neuroimmunologicaly mediated migraine variant syndrome with significant genetic predisposition and a variety of internal and external trigger factors including allergens, non-specific organic irritants, ingestible neuroactive substances, hormonal changes, dehydration and hypoglycemia. The great majority of patients can be successfully managed with low impact pharmacotherapy and dietary modifications. A prospective, parallel group, double blind, placebo controlled study is planned.
8QQ Results of a Comparative Trial Measuring Rate of Symptom L I I U Relief in Patients With Acute Bacterial Sinusitis Gavin Corcoran*, James F Lawless§, Daniel Haverstock*, Cheryl Pause*, Miriam Faruqi*, Deborah Church* *Bayer Corporation, West Haven, CT §F F M Clinical Research, Camillus, NY BACKGROUND: Acute bacterial sinusitis (ABS) affects more than 30 million individuals each year in the United States and is associated with substantial patient morbidity. In a recent 1-year study, 26.7 million physician visits were attributable to sinusitis and related airway disorders. Additionally, the symptoms experienced by sinusitis patients result in a considerable negative effect on quality of life. METHODS: Patients diagnosed with ABS were enrolled in this multicenter, randomized, open label, three arm clinical trial. Patients received treatment for 10 days with one of the following regimens: moxifloxacin (MXF) 400 mg PO QD, levofloxacin (LEV) 500 mg PO QD, or amoxicillin clavulanate (AMC) 875/125 mg PO BID. Sinusitis symptom improvement was assessed on a daily basis using the Sino-Nasal Outcomes Test-16 (SNOT-16). Also, the rate of callbacks to the physician's office was measured through 14 days after therapy and the reason for the callback was recorded. All patients receiving at least one dose of study drug comprised the intent-to-treat (ITT) population. RESULTS: Within a subset of 746 patients in the ITT population, 715 (96%) had completed SNOT- 16 assessments at pre-treatment and day 3. Of these 715 patients, 45% (104/233) of MXF-, 42% (102/242) of LEV- and 40% (97/240) of AMC-treated patients reported symptomatic relief by day 3 of therapy. Differences between groups did not reach statistical significance. For the 746 ITT patients, the rates of patients making callbacks attributed to lack of symptom relief were 7% (18/247) of MXF-, 11% (28/248) of LEV-, and 13% (32/251) of AMC-treated patients. CONCLUSION: The rates of symptom relief observed in this study suggest that MXF-treated patients "feel better faster" than LEV- and AMCtreated patients and, in addition, may have less need to contact their physician's office. With clinical equivalence often established between comparator drugs, other outcome measures become increasingly relevant. The implications of faster symptom relief as provided by MXF treatment may positively influence patient quality of life, well-being, and productivity.
889
Health Demographicsof ObstructiveAirway Disease in the Disadvantaged Elderly of Chicago
D Abraham, LC Grammer, CA Saltoun, P Yarnold, A Malik Northwestern University Medical School, Chicago, IL BACKGROUND: Asthma is a common, chronic respiratory disease often described in younger age groups. However. it is common in the elderly as well and is often underdiagnosed. A particular subset of elderly often not represented are the economically disadvantaged. OBJECTIVE: The objective of this cross-sectional study was to describe the differences in a variety of health demographics and quality of life measurements between the disadvantaged elderly with doctor diagnosed asthma and those without diagnosed asthma. METHODS: The research subjects were recruited from 3 city subsidized facilities for the elderly. The research subjects agreed to complete a questionnaire about their health. They received a $10 gift certificate to a