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267 A comparison of fluticasone propionate via Diskus™(Accuhaler™) inhaler and budesonide via Turbuhaler™ inhaler in adult asthmatics
J ALLERGY CLIN IMMONOL
Abstracts
249
VOLUME 97, NUMBER 1, PART 3
265
Study of Employees with Anhydride-Induced R e s p i r a t o r y Disease a f t e r R e m o v a l f r o m E x p o s u r e . LC Grammer ME), MA Shaughnessy BS, Chicago, 1L Purpose: To determine clinical and immunologic status of hexahydrophtbalic anhydride (HHPA) exposed employees who had developed an immunologic respiratory disease and who have been removed from exposure for at least one year. Methods: In a surveillance study spanning 4 years, we identified 28 employees with HHPA-induced immunologic respiratory disease who had been removed from exposure for at least one year. Seven had asthma, 9 had hemorrhagic rhinitis, 4 had both, and 8 had allergic rhinitis alone. Respiratory symptoms were assessed by physician administered questionnaire. Physical examination, spirometry, and chest film were performed. Antibody against HHPA conjugated to human serum albumin (HHP-HSA) was measured using an ELISA. Results: Symptoms, signs, and spirometry normalized in all but one employee. There were no chest film findings at follow-up attributed to HHPA. There was a decline in antibody titer for both lgE and lgG against HHP-HSA. Conclusions: In this group of 28 employees, there was only one employee with mild asthma after removal from exposure for at least one year. While specific antibody was still present in many, the titers were generally lower at follow-up than at presentation.
287
A contparison of fluticasone propionate via DiskusrM(Accuhaler TM) i n h a l e r a n d b u d e s o n i d e via T u r b u h a l e r TM i n h a l e r in a d u l t a s t h m a t i c s . R Backman MD t. CAC Pickering FRCP2. C Baumgarten MD 3, SC Huskisson MA 4, Meltola. Finland I. Manchester. UK2, Berlin. Germany3. Greelfford. UK4 A muhicentre, randomised, open, parallel group study was carried out to compare 2 inhaled steroid treatment regimens, flutieasone propionate (FP) 250~.tg bid via Diskus TM inhaler (D) and budesonide (B) 6001.tg bid via Turbuhale& M inhaler (T). 277 patients (155 male) with asthma aged 18-87years with baseline FEVt 50%-90% predicted and treated with 400-1200p.g/day inhaled steroid, were randontised to treatment with FP via D (137 patients) or B xia T (140 patients). No sigqificant differences were seen between the two treatments for the primary, eflit.~:ey variable mean morning PEFR (adjusted means 403L/rain (FP) and 400L/rain (B): 95%CL for difference -5.1,11.3L/min, p=0.456) or mV other efficacy parameter. Device handling assessments favoured D over T" 81% patients used D correctly first time compared x~ith 61% for T; 65% rated D ,,xry easy to use vs 47% for T. 83% liked D compared with 75% for T (p=NS). 80% patients would be happy to be prescibed D compared with 65% for T (p=0.023). FP 250}.tg bid via D and B 600p.g bid via T are equally effective in treatment of asthma but patients rated D more highly than T. Diskus, Accuhalcr are trademarks of the Glaxo Wellcome group of companies. Turbuhaleris a Irademark of Astra.
266
PATIENT SATISFACTION WITH A MULTI.DOSE POWDER INHALER (MDPI) DEVICE IN TREATMENT OF ASTHMA P. Mahajan, Ph.D, L. Okamoto, Pharm.D.J. Schaumberg, Ph.D, M. Goldstein, M.D. RTP, NC, Philadelphia, PA As a part of a randomized, double-blind, double-dummy, placebocontrolled study (N=210) evaluating salmetero150 meg BID via MDPI or DiskhalerTM device over a 4-week period, patients with asthma rated the importance of and their satisfaction with the MDPI. Patients' ability to use the device (open, slide the lever and close it) was also evaluated. The majority of patients considered all attributes assessed as important characteristics of any inhalation device. At both visits, patient satisfaction measures indicated that the majority of mtients favorably rated all attributes of the MDPI (Table). Percentage Respondingthat Attribute is Importantand Pereenta[e With Favorable Satisfaction Scores Importance Satisfaction Assessment Screening Screening Final Like the device NA 84 81 Comfort usingthe device NA 73 76 NA 92 92 Ease of use Ease to hold and operate 83 94 94 96 96 Able to tell no. of doses left 77 Durability 85 NA 85 Convenient to carry 88 NA 73 Satisfaction NA NA 80 Assessments indicated that almost all patients (_>_99%)were able to effectively use the MDPI at the very first visit. Results indicate that patients were satisfied with the MDPI and could comfortably use it following initial exposure. These findings suggest that this breathactuated device may be a good alternative to traditional aerosolized metered-dose inhalers.
268
Comparison Trial of Pirbuterol Acetate Administered Via A Breath-Actuated Inhaler with Albuterol Administered by a MDI with a S p a c i n g D e v i c e . J Grossman, D G Tinkelman, I Ziment, Tucson, AZ Objective: Difficulties have been demonstrated in coordination of actuation and inhalation of conventional metered dose inhalers (IvlDls). The objective of this stud)' was to compare two methods for overcoming these difficulties and determine tf patients maintained the santo degree of asthma control when using the breath-actuated Maxair T M Autohaler T M to deliver pirbuterol acetate aerosol compared with using albuterol (Ventolinqi_~)administered by MDI and a spacing de, ice (AcroChamber~9). Methods: This trit4 was a multi-orator randmnized, open-label, two-period (4 weeks each) crossover comparison m patients w~th chronic stable astl.ma. Asthma comrol was the priin~, measurement as assessed by ant mid pm peak flo~x measurements, asthma symptom scores, study medic,ation beta-2 use. and concomitant astlmla medication use. A patient questionnmre on the case of use for each device was also cmnpared. Results: Sixtyfive patients were randotuized to treatment with 54 asthma pattents completing both periods. There were no climeal or statisttcal differences between the Maxair Autohaler and Ventolin MDI with spacer for atLvof the prinmry efficacy variables or safety parameters (80% power to detect a 20% difference at alpha=0.05). Both treatments afforded effective asthma control. The Maxair Autohalcr was consistendy rated as easier to use, easier to carD', and preferred by patients over the MDI and spacer. Conclusion: This stud)' demonstrated that patients maintained the same degree of asthma control using Maxair Autohaler and Ventolin MDI with spacer as demonstrated by peak flow measurements and asthma symptom scores. Patients preferred the Maxair Autolmler and rated it easier to use and caster to carry, than the MDI wtth spacer.
Abstracts
249
VOLUME 97, NUMBER 1, PART 3
265
Study of Employees with Anhydride-Induced R e s p i r a t o r y Disease a f t e r R e m o v a l f r o m E x p o s u r e . LC Grammer ME), MA Shaughnessy BS, Chicago, 1L Purpose: To determine clinical and immunologic status of hexahydrophtbalic anhydride (HHPA) exposed employees who had developed an immunologic respiratory disease and who have been removed from exposure for at least one year. Methods: In a surveillance study spanning 4 years, we identified 28 employees with HHPA-induced immunologic respiratory disease who had been removed from exposure for at least one year. Seven had asthma, 9 had hemorrhagic rhinitis, 4 had both, and 8 had allergic rhinitis alone. Respiratory symptoms were assessed by physician administered questionnaire. Physical examination, spirometry, and chest film were performed. Antibody against HHPA conjugated to human serum albumin (HHP-HSA) was measured using an ELISA. Results: Symptoms, signs, and spirometry normalized in all but one employee. There were no chest film findings at follow-up attributed to HHPA. There was a decline in antibody titer for both lgE and lgG against HHP-HSA. Conclusions: In this group of 28 employees, there was only one employee with mild asthma after removal from exposure for at least one year. While specific antibody was still present in many, the titers were generally lower at follow-up than at presentation.
287
A contparison of fluticasone propionate via DiskusrM(Accuhaler TM) i n h a l e r a n d b u d e s o n i d e via T u r b u h a l e r TM i n h a l e r in a d u l t a s t h m a t i c s . R Backman MD t. CAC Pickering FRCP2. C Baumgarten MD 3, SC Huskisson MA 4, Meltola. Finland I. Manchester. UK2, Berlin. Germany3. Greelfford. UK4 A muhicentre, randomised, open, parallel group study was carried out to compare 2 inhaled steroid treatment regimens, flutieasone propionate (FP) 250~.tg bid via Diskus TM inhaler (D) and budesonide (B) 6001.tg bid via Turbuhale& M inhaler (T). 277 patients (155 male) with asthma aged 18-87years with baseline FEVt 50%-90% predicted and treated with 400-1200p.g/day inhaled steroid, were randontised to treatment with FP via D (137 patients) or B xia T (140 patients). No sigqificant differences were seen between the two treatments for the primary, eflit.~:ey variable mean morning PEFR (adjusted means 403L/rain (FP) and 400L/rain (B): 95%CL for difference -5.1,11.3L/min, p=0.456) or mV other efficacy parameter. Device handling assessments favoured D over T" 81% patients used D correctly first time compared x~ith 61% for T; 65% rated D ,,xry easy to use vs 47% for T. 83% liked D compared with 75% for T (p=NS). 80% patients would be happy to be prescibed D compared with 65% for T (p=0.023). FP 250}.tg bid via D and B 600p.g bid via T are equally effective in treatment of asthma but patients rated D more highly than T. Diskus, Accuhalcr are trademarks of the Glaxo Wellcome group of companies. Turbuhaleris a Irademark of Astra.
266
PATIENT SATISFACTION WITH A MULTI.DOSE POWDER INHALER (MDPI) DEVICE IN TREATMENT OF ASTHMA P. Mahajan, Ph.D, L. Okamoto, Pharm.D.J. Schaumberg, Ph.D, M. Goldstein, M.D. RTP, NC, Philadelphia, PA As a part of a randomized, double-blind, double-dummy, placebocontrolled study (N=210) evaluating salmetero150 meg BID via MDPI or DiskhalerTM device over a 4-week period, patients with asthma rated the importance of and their satisfaction with the MDPI. Patients' ability to use the device (open, slide the lever and close it) was also evaluated. The majority of patients considered all attributes assessed as important characteristics of any inhalation device. At both visits, patient satisfaction measures indicated that the majority of mtients favorably rated all attributes of the MDPI (Table). Percentage Respondingthat Attribute is Importantand Pereenta[e With Favorable Satisfaction Scores Importance Satisfaction Assessment Screening Screening Final Like the device NA 84 81 Comfort usingthe device NA 73 76 NA 92 92 Ease of use Ease to hold and operate 83 94 94 96 96 Able to tell no. of doses left 77 Durability 85 NA 85 Convenient to carry 88 NA 73 Satisfaction NA NA 80 Assessments indicated that almost all patients (_>_99%)were able to effectively use the MDPI at the very first visit. Results indicate that patients were satisfied with the MDPI and could comfortably use it following initial exposure. These findings suggest that this breathactuated device may be a good alternative to traditional aerosolized metered-dose inhalers.
268
Comparison Trial of Pirbuterol Acetate Administered Via A Breath-Actuated Inhaler with Albuterol Administered by a MDI with a S p a c i n g D e v i c e . J Grossman, D G Tinkelman, I Ziment, Tucson, AZ Objective: Difficulties have been demonstrated in coordination of actuation and inhalation of conventional metered dose inhalers (IvlDls). The objective of this stud)' was to compare two methods for overcoming these difficulties and determine tf patients maintained the santo degree of asthma control when using the breath-actuated Maxair T M Autohaler T M to deliver pirbuterol acetate aerosol compared with using albuterol (Ventolinqi_~)administered by MDI and a spacing de, ice (AcroChamber~9). Methods: This trit4 was a multi-orator randmnized, open-label, two-period (4 weeks each) crossover comparison m patients w~th chronic stable astl.ma. Asthma comrol was the priin~, measurement as assessed by ant mid pm peak flo~x measurements, asthma symptom scores, study medic,ation beta-2 use. and concomitant astlmla medication use. A patient questionnmre on the case of use for each device was also cmnpared. Results: Sixtyfive patients were randotuized to treatment with 54 asthma pattents completing both periods. There were no climeal or statisttcal differences between the Maxair Autohaler and Ventolin MDI with spacer for atLvof the prinmry efficacy variables or safety parameters (80% power to detect a 20% difference at alpha=0.05). Both treatments afforded effective asthma control. The Maxair Autohalcr was consistendy rated as easier to use, easier to carD', and preferred by patients over the MDI and spacer. Conclusion: This stud)' demonstrated that patients maintained the same degree of asthma control using Maxair Autohaler and Ventolin MDI with spacer as demonstrated by peak flow measurements and asthma symptom scores. Patients preferred the Maxair Autolmler and rated it easier to use and caster to carry, than the MDI wtth spacer.