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Takateru Izumi - One of the best experts on this subject based on the ideXlab platform.
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dose response study of Ipratropium bromide aerosol on maximum exercise performance in stable patients with chronic obstructive pulmonary disease
Thorax, 1996Co-Authors: Akihiko Ikeda, Koichi Nishimura, Hiroshi Koyama, Mitsuhiro Tsukino, Michiaki Mishima, Takateru IzumiAbstract:BACKGROUND: Although the bronchodilating effect of inhaled anticholinergics has been established in patients with chronic obstructive pulmonary disease (COPD), their effects on exercise capacity are still controversial. Previous studies have suggested that the standard dosage hardly affects exercise tolerance, whereas higher doses might elicit an improvement. The aim of the present study was to determine the dose of Ipratropium bromide aerosol that improves exercise performance using progressive cycle ergometry in patients with stable COPD. METHODS: Twenty men with stable COPD of mean (SD) age 69.2 (4.6) years and forced expiratory volume in one second (FEV1) 1.00 (0.37) 1 were studied in a randomised double blind manner. Each patient received Ipratropium bromide in doses of 240 micrograms, 160 micrograms, 80 micrograms, 40 micrograms, and placebo from a metered dose inhaler (MDI) with an InspirEase spacer on five separate days. Spirometric parameters were assessed before and at 30, 60, 90, and 120 minutes after each inhalation, and pulse rate and blood pressure were also measured immediately before each spirometric measurement. Symptom limited progressive (20 watts/min) cycle ergometer exercise tests were performed 90 minutes after each inhalation. RESULTS: Ipratropium bromide in doses of 160 micrograms and 240 micrograms produced a greater increase in FEV1 than 40 micrograms or 80 micrograms Ipratropium bromide at all time points. Doses of 160 micrograms and 240 micrograms Ipratropium bromide also produced greater increases in maximal work load and maximal oxygen consumption than placebo, whereas 40 micrograms and 80 micrograms Ipratropium bromide did not. There was a weak correlation between the change in FEV1 and the change in maximal work load (r = 0.45). No differences were found in pulse rate or blood pressure between the treatment and placebo groups, and no side effects were noted throughout the study. CONCLUSIONS: A dose of at least four times the standard dose of Ipratropium bromide from an MDI with a spacer device was necessary to improve maximal cycle exercise capacity in patients with stable COPD. Although the data from cycle ergometry cannot be directly applied to exercise performed during day to day activities, it is conceivable that the recommended doses of Ipratropium bromide do not elicit the optimal clinical benefits.
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Bronchodilating Effects of Combined Therapy With Clinical Dosages of Ipratropium Bromide and Salbutamol for Stable COPD:: Comparison With Ipratropium Bromide Alone
Chest, 1995Co-Authors: Akihiko Ikeda, Koichi Nishimura, Hiroshi Koyama, Takateru IzumiAbstract:Several studies have suggested that anticholinergics are at least equal to or may be superior to beta agonists in the treatment of stable COPD. However, since most previous studies have been performed to evaluate the bronchodilating effects of these two agents at relatively high doses, the clinical value of combining these two agents still is under debate. The purpose of this study was to determine if combination therapy with Ipratropium bromide and salbutamol, in clinically available dosages, is superior in bronchodilation to Ipratropium bromide alone. Twenty-six male patients (mean age, 67.5±5.9 years; FEV 1 , 0.87±0.32 L) with stable COPD were studied in randomized, double-blind, placebo-controlled experiments. On five separate days, all the patients received one of the following: (1) 40 µg Ipratropium bromide, (2) 80 µg Ipratropium bromide, (3) 40 µg Ipratropium bromide plus 200 µg salbutamol, (4) 80 µg Ipratropium bromide plus 400 µg salbutamol, or (5) placebo, using metered-dose inhalers (MDIs). Spirometry was assessed before and 15, 30, 60, 90, and 120 min after inhalation. Positive FEV 1 responses to combined dosages of 80 µg Ipratropium bromide and 400 µg salbutamol were significantly greater than responses to any other treatment regimen. Significantly greater responses also were achieved by combining 200 µg salbutamol with 40 µg Ipratropium bromide compared with 40 µg Ipratropium bromide alone. Combination therapy with 200 µg salbutamol and 40 µg Ipratropium bromide produced a significantly greater effect on forced vital capacity than therapy with 80 µg Ipratropium bromide alone. No significant differences were found between the responses induced by therapy with 80 and 40 µg Ipratropium bromide. No adverse reactions to any regimen were noted throughout the study. In conclusion, combining the standard dosages of Ipratropium bromide and salbutamol may provide greater bronchodilation than doubling the standard dosage of Ipratropium bromide in patients with COPD.
Y Zhao - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of Ipratropium bromide albuterol delivered via respimat inhaler versus mdi
Respiratory Medicine, 2010Co-Authors: Richard Zuwallack, M C De Salvo, T Kaelin, Eric D Bateman, Choonsik Park, R Abrahams, F Fakih, P Sachs, Krishna Pudi, Y ZhaoAbstract:Summary We compared the efficacy and safety of Ipratropium bromide/albuterol delivered via Respimat ® inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and Ipratropium Respimat ® inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study. Patients with moderate to severe COPD were randomized to Ipratropium bromide/albuterol (20/100mcg) Respimat ® inhaler, Ipratropium bromide/albuterol MDI [36mcg/206mcg (Combivent ® Inhalation Aerosol MDI)], or Ipratropium bromide (20mcg) Respimat ® inhaler. Each medication was administered four times daily. Serial spirometry was performed over 6h (0.15min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1s (FEV 1 ) change from test day baseline at 12 weeks. A total of 1209 of 1480 randomized, treated patients completed the study; the majority were male (65%) with a mean age of 64 yrs and a mean screening pre-bronchodilator FEV 1 (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat ® inhaler had comparable efficacy to Ipratropium bromide/albuterol MDI for FEV 1 area under the curve at 0–6h (AUC 0–6 ), superior efficacy to Ipratropium Respimat ® inhaler for FEV 1 AUC 0–4 and comparable efficacy to Ipratropium Respimat ® inhaler for FEV 1 AUC 4–6 . All active treatments were well tolerated. This study demonstrates that Ipratropium bromide/albuterol 20/100mcg inhaler ® administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to Ipratropium bromide/albuterol 36mcg/206mcg MDI, and significantly improved lung function compared with the mono-component Ipratropium bromide 20 mcg Respimat ® inhaler. [Clinical Trial Identifier Number: NCT00400153]
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Efficacy and safety of Ipratropium bromide/albuterol delivered via Respimat® inhaler versus MDI
Respiratory medicine, 2010Co-Authors: Richard Zuwallack, M C De Salvo, T Kaelin, Eric D Bateman, Choonsik Park, R Abrahams, F Fakih, P Sachs, Krishna Pudi, Y ZhaoAbstract:Summary We compared the efficacy and safety of Ipratropium bromide/albuterol delivered via Respimat ® inhaler, a novel propellant-free inhaler, versus chlorofluorocarbon (CFC)-metered dose inhaler (MDI) and Ipratropium Respimat ® inhaler in patients with COPD. This was a multinational, randomized, double-blind, double-dummy, 12-week, parallel-group, active-controlled study. Patients with moderate to severe COPD were randomized to Ipratropium bromide/albuterol (20/100mcg) Respimat ® inhaler, Ipratropium bromide/albuterol MDI [36mcg/206mcg (Combivent ® Inhalation Aerosol MDI)], or Ipratropium bromide (20mcg) Respimat ® inhaler. Each medication was administered four times daily. Serial spirometry was performed over 6h (0.15min, then hourly) on 4 test days. The primary efficacy variable was forced expiratory volume in 1s (FEV 1 ) change from test day baseline at 12 weeks. A total of 1209 of 1480 randomized, treated patients completed the study; the majority were male (65%) with a mean age of 64 yrs and a mean screening pre-bronchodilator FEV 1 (percent predicted) of 41%. Ipratropium bromide/albuterol Respimat ® inhaler had comparable efficacy to Ipratropium bromide/albuterol MDI for FEV 1 area under the curve at 0–6h (AUC 0–6 ), superior efficacy to Ipratropium Respimat ® inhaler for FEV 1 AUC 0–4 and comparable efficacy to Ipratropium Respimat ® inhaler for FEV 1 AUC 4–6 . All active treatments were well tolerated. This study demonstrates that Ipratropium bromide/albuterol 20/100mcg inhaler ® administered four times daily for 12 weeks had equivalent bronchodilator efficacy and comparable safety to Ipratropium bromide/albuterol 36mcg/206mcg MDI, and significantly improved lung function compared with the mono-component Ipratropium bromide 20 mcg Respimat ® inhaler. [Clinical Trial Identifier Number: NCT00400153]
Akihiko Ikeda - One of the best experts on this subject based on the ideXlab platform.
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dose response study of Ipratropium bromide aerosol on maximum exercise performance in stable patients with chronic obstructive pulmonary disease
Thorax, 1996Co-Authors: Akihiko Ikeda, Koichi Nishimura, Hiroshi Koyama, Mitsuhiro Tsukino, Michiaki Mishima, Takateru IzumiAbstract:BACKGROUND: Although the bronchodilating effect of inhaled anticholinergics has been established in patients with chronic obstructive pulmonary disease (COPD), their effects on exercise capacity are still controversial. Previous studies have suggested that the standard dosage hardly affects exercise tolerance, whereas higher doses might elicit an improvement. The aim of the present study was to determine the dose of Ipratropium bromide aerosol that improves exercise performance using progressive cycle ergometry in patients with stable COPD. METHODS: Twenty men with stable COPD of mean (SD) age 69.2 (4.6) years and forced expiratory volume in one second (FEV1) 1.00 (0.37) 1 were studied in a randomised double blind manner. Each patient received Ipratropium bromide in doses of 240 micrograms, 160 micrograms, 80 micrograms, 40 micrograms, and placebo from a metered dose inhaler (MDI) with an InspirEase spacer on five separate days. Spirometric parameters were assessed before and at 30, 60, 90, and 120 minutes after each inhalation, and pulse rate and blood pressure were also measured immediately before each spirometric measurement. Symptom limited progressive (20 watts/min) cycle ergometer exercise tests were performed 90 minutes after each inhalation. RESULTS: Ipratropium bromide in doses of 160 micrograms and 240 micrograms produced a greater increase in FEV1 than 40 micrograms or 80 micrograms Ipratropium bromide at all time points. Doses of 160 micrograms and 240 micrograms Ipratropium bromide also produced greater increases in maximal work load and maximal oxygen consumption than placebo, whereas 40 micrograms and 80 micrograms Ipratropium bromide did not. There was a weak correlation between the change in FEV1 and the change in maximal work load (r = 0.45). No differences were found in pulse rate or blood pressure between the treatment and placebo groups, and no side effects were noted throughout the study. CONCLUSIONS: A dose of at least four times the standard dose of Ipratropium bromide from an MDI with a spacer device was necessary to improve maximal cycle exercise capacity in patients with stable COPD. Although the data from cycle ergometry cannot be directly applied to exercise performed during day to day activities, it is conceivable that the recommended doses of Ipratropium bromide do not elicit the optimal clinical benefits.
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Bronchodilating Effects of Combined Therapy With Clinical Dosages of Ipratropium Bromide and Salbutamol for Stable COPD:: Comparison With Ipratropium Bromide Alone
Chest, 1995Co-Authors: Akihiko Ikeda, Koichi Nishimura, Hiroshi Koyama, Takateru IzumiAbstract:Several studies have suggested that anticholinergics are at least equal to or may be superior to beta agonists in the treatment of stable COPD. However, since most previous studies have been performed to evaluate the bronchodilating effects of these two agents at relatively high doses, the clinical value of combining these two agents still is under debate. The purpose of this study was to determine if combination therapy with Ipratropium bromide and salbutamol, in clinically available dosages, is superior in bronchodilation to Ipratropium bromide alone. Twenty-six male patients (mean age, 67.5±5.9 years; FEV 1 , 0.87±0.32 L) with stable COPD were studied in randomized, double-blind, placebo-controlled experiments. On five separate days, all the patients received one of the following: (1) 40 µg Ipratropium bromide, (2) 80 µg Ipratropium bromide, (3) 40 µg Ipratropium bromide plus 200 µg salbutamol, (4) 80 µg Ipratropium bromide plus 400 µg salbutamol, or (5) placebo, using metered-dose inhalers (MDIs). Spirometry was assessed before and 15, 30, 60, 90, and 120 min after inhalation. Positive FEV 1 responses to combined dosages of 80 µg Ipratropium bromide and 400 µg salbutamol were significantly greater than responses to any other treatment regimen. Significantly greater responses also were achieved by combining 200 µg salbutamol with 40 µg Ipratropium bromide compared with 40 µg Ipratropium bromide alone. Combination therapy with 200 µg salbutamol and 40 µg Ipratropium bromide produced a significantly greater effect on forced vital capacity than therapy with 80 µg Ipratropium bromide alone. No significant differences were found between the responses induced by therapy with 80 and 40 µg Ipratropium bromide. No adverse reactions to any regimen were noted throughout the study. In conclusion, combining the standard dosages of Ipratropium bromide and salbutamol may provide greater bronchodilation than doubling the standard dosage of Ipratropium bromide in patients with COPD.
Theodore J. Witek - One of the best experts on this subject based on the ideXlab platform.
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Ipratropium bromide hydrofluoroalkane inhalation aerosol is safe and effective in patients with COPD.
Chest, 2001Co-Authors: James A. Taylor, Arthur Kotch, Kathryn L. Rice, Mo Ghafouri, Caryn L. Kurland, Nora M. Fagan, Theodore J. WitekAbstract:Study objective To compare the efficacy and safety of Ipratropium bromide reformulated with the chlorofluorocarbon (CFC)-free propellant hydrofluoroalkane (HFA)-134a (Ipratropium bromide HFA) to that of the marketed Ipratropium bromide inhalation aerosol (containing CFC) in patients with COPD. Design This was a randomized, double-blind, parallel-group, placebo-controlled, multicenter trial. The primary efficacy parameter was acute bronchodilator response. The primary end points were peak change in FEV 1 from baseline and area under the response-time curve. Setting Thirty-one clinical centers in the United States participated in this project. Patients A total of 507 patients with moderate-to-severe COPD were randomized, and 444 patients completed the trial. Interventions Twelve weeks of treatment four times daily with one of the following: Ipratropium bromide HFA, 42 μg; Ipratropium bromide HFA, 84 μg; HFA placebo; Ipratropium bromide inhalation aerosol, 42 μg; or CFC placebo. Measurements and results Patients in all active treatment groups had significant bronchodilator responses as shown by increases in mean FEV 1 from baseline of at least 15%. Bronchodilator response in all active treatment groups was also significantly more than their respective placebo treatments based on FEV 1 , area under the time-response curve from 0 to 6 h, and peak response. FVC results were similar to those seen with FEV 1 . There were no significant differences in adverse events, laboratory findings, or ECG findings among the treatment groups. Conclusions Ipratropium bromide HFA, 42 μg, provided bronchodilation comparable to the marketed Ipratropium bromide CFC, 42 μg, over 12 weeks of regular use.
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the combination of Ipratropium and albuterol optimizes pulmonary function reversibility testing in patients with copd
Chest, 1999Co-Authors: Paul M Dorinsky, Gary T. Ferguson, Charles W. Serby, Shailendra Menjoge, Colin Reisner, Theodore J. WitekAbstract:Study objectives: To determine whether the combination of Ipratropium bromide and albuterol results in greater and more consistent pulmonary function test (PFT) response rates than Ipratropium bromide or albuterol alone in patients with COPD. Design: Retrospective review of two recently completed 3-month, randomized, double-blind, parallel, multicenter, phase III trials. Setting: Outpatient. Patients: A total of 1,067 stable patients with COPD. Interventions: Ipratropium bromide (36 mg qid), albuterol base (180 mg qid), or an equivalent combination of Ipratropium bromide and albuterol sulfate (42 mg and 240 mg qid, respectively). Measurements and results: PFT response rates were analyzed using 12% and 15% increases in FEV1 compared with baseline values and were measured in the various treatment groups on days 1, 29, 57, and 85 in these trials. Regardless of whether a 12% or a 15% increase in FEV1 was used to define a positive response, an equivalent combination of Ipratropium bromide and albuterol sulfate was superior to the individual agents (p 80% of patients who received the combination of Ipratropium and albuterol sulfate during the initial PFT and continued to be observed 3 months after initial testing. Conclusions: Use of a combination of Ipratropium bromide and albuterol sulfate is superior to the individual agents in identifying PFT reversibility in patients with COPD. (CHEST 1999; 115:966 ‐971)
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Pharmacoeconomic evaluation of a combination of Ipratropium plus albuterol compared with Ipratropium alone and albuterol alone in COPD.
Chest, 1999Co-Authors: Mitchell Friedman, Charles W. Serby, Shailendra Menjoge, J. Douglas Wilson, Daniel E. Hilleman, Theodore J. WitekAbstract:Study objective To conduct a post hoc pharmacoeconomic evaluation of two double-blind, randomized, prospective, parallel group studies comparing the long-term efficacy and safety of Ipratropium combined with albuterol in a single inhalational canister against either bronchodilator agent alone in patients with COPD. Patients One thousand sixty-seven patients with COPD. Methods The dose of each bronchodilator was two puffs four times a day (42 μg of Ipratropium bromide, 240 μg of albuterol sulfate). Pulmonary function testing was performed on days 1, 29, 57, and 85 of treatment. Outcomes, health-care resource consumption, and costs were compared for the three treatment groups over the 85-day study period. A total of 1,067 patients were randomized in the two studies (albuterol alone, n = 347; Ipratropium alone, n = 362; albuterol plus Ipratropium, n = 358). Results Improvement in FEV 1 and area under the FEV 1 response-time curve from time 0 to 4 h (FEV 1 AUC 0–4 ) was significantly greater for the combination of albuterol plus Ipratropium than either agent alone on all test days. Compared with albuterol, patients receiving Ipratropium and Ipratropium plus albuterol experienced significantly fewer COPD exacerbations and patient-days of exacerbation. In addition, the increased frequency of exacerbations observed in the albuterol group was associated with a significant increase in the number of patient hospital days and antibiotic and corticosteroid use. As a result, the total cost of treatment over the study period was significantly less for Ipratropium ($156 per patient) and Ipratropium plus albuterol ($197 per patient) than for albuterol ($269 per patient). Increased cost-effectiveness, defined as total estimated treatment cost per mean change in FEV 1 AUC 0–4 , was observed in both treatment arms containing Ipratropium. Conclusions The inclusion of Ipratropium in a pharmacologic treatment regimen is associated with a lower rate of exacerbations in COPD. The result is lower total treatment costs and improved cost-effectiveness.
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a comparison of Ipratropium and albuterol vs albuterol alone for the treatment of acute asthma
Chest, 1996Co-Authors: J P Karpel, Shailendra Menjoge, E N Schacter, Christopher H Fanta, D Levey, P Spiro, Thomas K Aldrich, Theodore J. WitekAbstract:To evaluate the role of inhaled Ipratropium bromide in acute asthma, a double-blind study of 384 emergency department patients compared the effect of the combination of Ipratropium and albuterol with that of albuterol alone. Patients were randomized to receive nebulizer treatments with either 2.5 mg of albuterol or 2.5 mg of albuterol mixed with 0.5 mg of Ipratropium bromide at entry and at 45 min. Spirometry, vital signs, and oxygen saturation were measured before and at 45 and 90 min following the nebulizer treatments. Serum potassium levels were obtained at entry and 90 min. The two groups did not differ significantly in age (mean±SD=33.4±9.3 and 32.5±9.7 years for the albuterol and Ipratropium group and the albuterol group, respectively), baseline FEV1 (mean ± SD=1.22±0.42 and 1.25±0.44 L respectively), or prior use of asthma medications. At 45 min, there were significantly more responders (15% increase in FEV1 over baseline) in the group receiving albuterol and Ipratropium compared with albuterol and saline solution (85% and 78%, respectively; p=0.045), but the median change in FEV1 from baseline did not differ (0.530 L for the albuterol and Ipratropium group and 0.420 L for the albuterol and saline solution group; p=0.347). By 90 min, the percentage of responders did not differ (88% and 89%, respectively), and the median change in FEV1 was 0.680 L for the group receiving albuterol and Ipratropium and 0.650 L for the group receiving albuterol and saline solution (p=0.693). There were no significant adverse events experienced by patients in either group. Furthermore, there were no significant differences in the number of patients requiring additional therapy in the emergency department or hospitalization. We conclude that in this population of inner city asthmatics, we were unable to demonstrate significant additive benefit of nebulized Ipratropium bromide to nebulized albuterol. (CHEST 1996; 110:611-16)
Margaret T Wecker - One of the best experts on this subject based on the ideXlab platform.
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effectiveness and safety of intranasal Ipratropium bromide in common colds a randomized double blind placebo controlled trial
Annals of Internal Medicine, 1996Co-Authors: Frederick G. Hayden, Louis Diamond, Pauline B Wood, David C Korts, Margaret T WeckerAbstract:OBJECTIVE To determine the tolerability and clinical effectiveness of intranasal Ipratropium bromide for the treatment of symptoms of common colds. DESIGN Multicenter, double-blind, randomized trial. SETTING 3 university student health services. PATIENTS 411 previously healthy persons 14 to 56 years of age who had cold symptoms that had lasted for no more than 36 hours, rhinorrhea subjectively judged to be of at least moderate severity, and documented nasal discharge of at least 1.5 g over a 1-hour observation period. INTERVENTION Either 1) Ipratropium bromide nasal spray 0.06% in buffered salt solution, two 42-micrograms sprays per nostril administered by metered pump spray; 2) control nasal spray, which consisted of buffered salt solution; or 3) no treatment. Treatments were self-administered three or four times daily during waking hours for 4 days. After receiving their morning dose, patients stayed at the study center for 6 hours on study day 1 and 3 hours on study day 2; symptom severity was recorded and nasal mucus discharges were collected and weighed hourly during these periods. RESULTS Ipratropium recipients had 26% less nasal discharge than controls (P = 0.0024) and 34% less nasal discharge than untreated patients (P = 0.0001). Severity of rhinorrhea as judged subjectively was reduced in Ipratropium recipients by 31% compared with controls and by 78% compared with untreated patients (P = 0.0001 for both comparisons). In addition to being associated with reductions in daily assessments of the severity of rhinorrhea (P < or = 0.003), Ipratropium was associated with reduced sneezing on study days 2 (20% difference; P = 0.03) and 4 (30% difference; P = 0.02) but not with reduced nasal congestion compared with the control spray. Ipratropium was generally well tolerated but was associated with higher rates of blood-tinged mucus (16.8% in the Ipratropium group compared with 3.6% in the control group; P = 0.01) and nasal dryness (11.7% in the Ipratropium group compared with 3.6% in the control group; P = 0.021) than the control spray. Patient assessments of the overall effectiveness of treatment were more favorable for Ipratropium than for the control spray (P < or = 0.026) or for no treatment (P < or = 0.002) on each day of inquiry (study days 1, 2, and 5). CONCLUSIONS Intranasal Ipratropium bromide provides specific relief of rhinorrhea and sneezing associated with common colds.