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46 Airflow profiles and inhaler technique with the new mometasone furoate dry powder inhaler (MF-DPI)
J ALLERGY CLIN IMMUNOL JANUARY 2000
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47
Airflow Profiles and Inhaler Technique With the Ne;w Mometasone Furoate Dry Powder Inhaler (MF-DPI) D Miller*, E&her&elf, D Kenyon$, J Harrisonf *New England Research Center, North Dartmouth, MA, USA tValley Clinical Research Center, Easton, PA, USA SSchering-Plough Research Institute, Kenilworth, NJ, USA Patients’ airflow during inhalation is a key determinant of DPI performance; therefore we assessed airflow profiles and inhaler technique at two separate visits to the clinic among 17 adults involved in a 12week, placebo-controlled study of MF-DPI in the treatment of mild and moderate asthma. We used a functional model of the MF-DPI connected to a microprocessor that measures inspiratory flow rate (IFR), IFR rise time (the rapidity of inhalation), and duration of inspiration. One configuration, the MF-DPI trainer, was used to teach and reinforce proper inhaler technique by providing feedback to the patient by means of colored lights indicating IFRs and rise times relative to optimal levels. Airflow data were formally recorded using the MF-DPI trainer attached to a laptop computer. The first set of airflow profiles was obtained at the baseline visit. at which time all patients achieved IFRs 260 Umin and rise times ~300 msec. A second set of profiles was obtained at the study endpoint, and the same results were achieved (see Figure), with the exception of one patient whose rise time was ~300 msec. Based on in vitro studies, the MF-DPI requires IFRs of at least 20 Umin and rise times ~300 msec to deliver a precise dose of MF relative to claimed delivery, and that IFRs of approximately 60 Umin provide optimal distribution of respirable particles. Therefore, we conclude that all but one patient in the present study generated airflow profiles sufficient to deliver precise doses of medication with the MF-DPI, and that proper inhaler technique was maintained over time.
Pediatric Airtlow Profiles With the New Mometasone Furoate Dry Powder Inhaler (MF-DPI) D Skoner*, B Angelini*, D Gentile*, D Kenyont *Children’s Hospital, Pittsburgh, PA, USA tSchering-Plough Research Institute, Kenilworth, NJ, USA To determine the practicality of the MFDPI for pediatric use, we assessed airflow profiles and inhaler technique among children involved in a placebo-controlled clinical study of MF-DPI. Airflow profiles were obtained from 55 children with mild persistent asthma, ranging in age from 5 to 12 years, at two separate visits to the clinic. At each visit, inspiratory flow rate (JFR), 1FR rise time (the rapidity of inhalation), and duration of inspiration were measured with a functional model of the MF-DPI connected to a microprocessor. One configuration of the MF-DPI trainer was used to teach and reinforce proper inhaler technique by providing feedback to the patient by way of colored lights indicating IFRs and rise times relative to optimal levels. Airflow data were formally recorded using the MF-DPI trainer attached to a laptop computer. The first set of airflow profiles was obtained upon screening for enrollment in the study, at which time the average IFR was :*55 Ymin. The same results were achieved when a second set of profiles was obtained at study baseline, which ranged from I to 2 weeks after screening (see Figure). The lowest IFRs were 46 Wmin among children 5 to 8 years old and 48 Umin among those 9 to 12 years old. Rise times were l 300 msec in both subgroups at both visits. Based on in vitro studies, reported elsewhere, the MF-DPI requires IFRs of at least 20 Wmin and rise times -300 msec to deliver a precise dose of MF relative to claimed delivery. At both visits in pre-
sent study, all patients generated adequate IFRs and rise times. We conclude that children as young as 5 years of age generated sufficient airflow to operate the MF-DPI, and that they maintained proper inhaler technique over time. A-
-Puramvna
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48 Assessing
the Impact of Fluticasone, Salmeterol, and Zatlrlukast Using Statistical Process Control Theory SW Yancey, L Edwards Research Triangle Park, NC Assessing the Impact of Fhrticasone, Salmeterol and Zafirlukast Using Statistical Process Control Theory. PB Boggs MD, SW Yancey MS, L Edwards PhD. Sherepon, LA, RTP, NC. Statistical process control is a methodology that uses graphic and statistical tools to analyze, control, and reduce variation within a process and it can be applied to assessing asthma therapies. By examining data in series (e.g., daily diary data), upper and lower natural process limits for this data can be calculated. These limits help to explain whether variation within an outcome (e.g., PEFR, asthma symptoms) is due to natural random variation or is due to an event outside of “normal” or natural variation (e.g., treatment effect). Values that fall below the lower natural process limit (LNPL) or above the upper natural process limit (UNPL) indicate asthma control well below or above natural random variation. A retrospective analysis of 533 patients from 4 studies ranging in duration of 4-l 2 weeks compared patients receiving fluticasone (F), salmeterol (S), zafirlukast (Z), or short-acting beta-agonist (A). Demographics were comparable between groups. The LNPL for AM PEFR improved from baseline by 63.4 1, 34, and 28 Vmin in F, S, Z, and A recipients, respectively. Each treatment was significantly improved from baseline, and F and S were significantly better than Z (p=O.OOS). The UNPL for asthma symptom scores improved from baseline by -.21, -.17, -. 13 and -. 13 and in F, S, 2 and A recipients respectively. Each treatment was significantly improved from baseline, and F and S were significantly better than Z (p
49
Anti-Inflammatory Properties of Desloratadine (DCL): Effect on Eosinophil Chemotaxis, Adhesion and Release of Superoxide Anions Devendra K. Agmwal*t$, Abdo Berro*$, William Kreutnet-j1 Robert G. Townley*f# *Allergic Disease Center tcreighton
46
47
Airflow Profiles and Inhaler Technique With the Ne;w Mometasone Furoate Dry Powder Inhaler (MF-DPI) D Miller*, E&her&elf, D Kenyon$, J Harrisonf *New England Research Center, North Dartmouth, MA, USA tValley Clinical Research Center, Easton, PA, USA SSchering-Plough Research Institute, Kenilworth, NJ, USA Patients’ airflow during inhalation is a key determinant of DPI performance; therefore we assessed airflow profiles and inhaler technique at two separate visits to the clinic among 17 adults involved in a 12week, placebo-controlled study of MF-DPI in the treatment of mild and moderate asthma. We used a functional model of the MF-DPI connected to a microprocessor that measures inspiratory flow rate (IFR), IFR rise time (the rapidity of inhalation), and duration of inspiration. One configuration, the MF-DPI trainer, was used to teach and reinforce proper inhaler technique by providing feedback to the patient by means of colored lights indicating IFRs and rise times relative to optimal levels. Airflow data were formally recorded using the MF-DPI trainer attached to a laptop computer. The first set of airflow profiles was obtained at the baseline visit. at which time all patients achieved IFRs 260 Umin and rise times ~300 msec. A second set of profiles was obtained at the study endpoint, and the same results were achieved (see Figure), with the exception of one patient whose rise time was ~300 msec. Based on in vitro studies, the MF-DPI requires IFRs of at least 20 Umin and rise times ~300 msec to deliver a precise dose of MF relative to claimed delivery, and that IFRs of approximately 60 Umin provide optimal distribution of respirable particles. Therefore, we conclude that all but one patient in the present study generated airflow profiles sufficient to deliver precise doses of medication with the MF-DPI, and that proper inhaler technique was maintained over time.
Pediatric Airtlow Profiles With the New Mometasone Furoate Dry Powder Inhaler (MF-DPI) D Skoner*, B Angelini*, D Gentile*, D Kenyont *Children’s Hospital, Pittsburgh, PA, USA tSchering-Plough Research Institute, Kenilworth, NJ, USA To determine the practicality of the MFDPI for pediatric use, we assessed airflow profiles and inhaler technique among children involved in a placebo-controlled clinical study of MF-DPI. Airflow profiles were obtained from 55 children with mild persistent asthma, ranging in age from 5 to 12 years, at two separate visits to the clinic. At each visit, inspiratory flow rate (JFR), 1FR rise time (the rapidity of inhalation), and duration of inspiration were measured with a functional model of the MF-DPI connected to a microprocessor. One configuration of the MF-DPI trainer was used to teach and reinforce proper inhaler technique by providing feedback to the patient by way of colored lights indicating IFRs and rise times relative to optimal levels. Airflow data were formally recorded using the MF-DPI trainer attached to a laptop computer. The first set of airflow profiles was obtained upon screening for enrollment in the study, at which time the average IFR was :*55 Ymin. The same results were achieved when a second set of profiles was obtained at study baseline, which ranged from I to 2 weeks after screening (see Figure). The lowest IFRs were 46 Wmin among children 5 to 8 years old and 48 Umin among those 9 to 12 years old. Rise times were l 300 msec in both subgroups at both visits. Based on in vitro studies, reported elsewhere, the MF-DPI requires IFRs of at least 20 Wmin and rise times -300 msec to deliver a precise dose of MF relative to claimed delivery. At both visits in pre-
sent study, all patients generated adequate IFRs and rise times. We conclude that children as young as 5 years of age generated sufficient airflow to operate the MF-DPI, and that they maintained proper inhaler technique over time. A-
-Puramvna
n~~hmrv
now M nnw
48 Assessing
the Impact of Fluticasone, Salmeterol, and Zatlrlukast Using Statistical Process Control Theory SW Yancey, L Edwards Research Triangle Park, NC Assessing the Impact of Fhrticasone, Salmeterol and Zafirlukast Using Statistical Process Control Theory. PB Boggs MD, SW Yancey MS, L Edwards PhD. Sherepon, LA, RTP, NC. Statistical process control is a methodology that uses graphic and statistical tools to analyze, control, and reduce variation within a process and it can be applied to assessing asthma therapies. By examining data in series (e.g., daily diary data), upper and lower natural process limits for this data can be calculated. These limits help to explain whether variation within an outcome (e.g., PEFR, asthma symptoms) is due to natural random variation or is due to an event outside of “normal” or natural variation (e.g., treatment effect). Values that fall below the lower natural process limit (LNPL) or above the upper natural process limit (UNPL) indicate asthma control well below or above natural random variation. A retrospective analysis of 533 patients from 4 studies ranging in duration of 4-l 2 weeks compared patients receiving fluticasone (F), salmeterol (S), zafirlukast (Z), or short-acting beta-agonist (A). Demographics were comparable between groups. The LNPL for AM PEFR improved from baseline by 63.4 1, 34, and 28 Vmin in F, S, Z, and A recipients, respectively. Each treatment was significantly improved from baseline, and F and S were significantly better than Z (p=O.OOS). The UNPL for asthma symptom scores improved from baseline by -.21, -.17, -. 13 and -. 13 and in F, S, 2 and A recipients respectively. Each treatment was significantly improved from baseline, and F and S were significantly better than Z (p
49
Anti-Inflammatory Properties of Desloratadine (DCL): Effect on Eosinophil Chemotaxis, Adhesion and Release of Superoxide Anions Devendra K. Agmwal*t$, Abdo Berro*$, William Kreutnet-j1 Robert G. Townley*f# *Allergic Disease Center tcreighton