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Effectiveness of antitussives, anticholinergics or honey versus usual care in adults with uncomplicated acute bronchitis: a study protocol of an open randomised clinical trial in primary care.
Cots, JM, Moragas, A, García-Sangenís, A, Morros, R, Gomez-Lumbreras, A, Ouchi, D, Monfà, R, Pera, H, Pujol, J, Bayona, C, et al
BMJ open. 2019;(5):e028159
Abstract
INTRODUCTION Despite the frequent use of therapies in acute bronchitis, the evidence of their benefit is lacking, since only a few clinical trials have been published, with low sample sizes, poor methodological quality and mainly in children. The objective of this study is to compare the effectiveness of three symptomatic therapies (dextromethorphan, ipratropium or honey) associated with usual care and the usual care in adults with acute bronchitis. METHODS AND ANALYSIS This will be a multicentre, pragmatic, parallel group, open randomised trial. Patients aged 18 or over with uncomplicated acute bronchitis, with cough for less than 3 weeks as the main symptom, scoring ≥4 in either daytime or nocturnal cough on a 7-point Likert scale, will be randomised to one of the following four groups: usual care, dextromethorphan 30 mg three times a day, ipratropium bromide inhaler 20 µg two puffs three times a day or honey 30 mg (a spoonful) three times a day, all taken for up to 14 days. The exclusion criteria will be pneumonia, criteria for hospital admission, pregnancy or lactation, concomitant pulmonary disease, associated significant comorbidity, allergy, intolerance or contraindication to any of the study drugs or admitted to a long-term residence. SAMPLE 668 patients. The primary outcome will be the number of days with moderate-to-severe cough. All patients will be given a paper-based symptom diary to be self-administered. A second visit will be scheduled at day 2 or 3 for assessing evolution, with two more visits at days 15 and 29 for clinical assessment, evaluation of adverse effects, re-attendance and complications. Patients still with symptoms at day 29 will be called 6 weeks after the baseline visit. ETHICS AND DISSEMINATION The study has been approved by the Ethical Board of IDIAP Jordi Gol (reference number: AC18/002). The findings of this trial will be disseminated through research conferences and peer-review journals. TRIAL REGISTRATION NUMBER NCT03738917; Pre-results.
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A double-blind crossover study comparing the safety and efficacy of three weeks of Flu/Sal 250/50 bid plus albuterol 180 ug prn q4 hours to Flu/Sal 250/50 bid plus albuterol/Ipratropium bromide 2 puffs prn q4 hours in patients with chronic obstructive pulmonary disease.
Balkissoon, R, Make, B
COPD. 2008;(4):221-7
Abstract
The Federal Drug Administration (FDA) approved the use of Fluticasone 250 microg/Salmeterol 50 microg 1 puff bid for maintenance therapy in patients with COPD associated with chronic bronchitis. Short-acting beta agonists (SABA) have been the recommended rescue medication; however, previous studies have shown that combination short-acting Albuterol (alb) /Ipratropium bromide (IB) has superior bronchodilator properties to albuterol alone in patients with COPD. The safety and efficacy of Albuterol compared to Albuterol/Ipratropium bromide as rescue medications for COPD patients on maintenance combination therapy of ICS/LABA has not been evaluated. Double-blind randomized crossover trial with COPD subjects receiving Fluticasone/ Salmeterol 500 microg/50 microg (Flu/Sal) 1 puff twice daily and 2 puffs of Albuterol Sulfate (90 microg micrograms per inhalation) or 2 puffs of Albuterol (90 microg/puff and Ipratropium Bromide 18 microg/puff. Either Albuterol Sulfate (90 micrograms/puff) or Alb (90 micrograms/puff)/IB used prn for 3 weeks before crossing over to the other rescue formulation. This is a non-inferiority study where safety and efficacy outcomes were serially assessed, including adverse events, Baseline (BDI)/Transition Dyspnea Index (TDI), St. George Respiratory Questionnaire (SGRQ), SF36, diary cards, 24-hour cardiac monitoring, potassium and glucose levels and other adverse events. Twenty subjects completed the study. The mean age was 62.5 (+/- 14.5); 12 were males. The mean baseline FEV(1) (range) was 1.12 L (0.56-1.67) or 40.6 (21-65)% predicted. There were no statistically significant differences between either rescue inhaler formulation with regard to measures neither of lung function or dyspnea nor in terms of safety parameters of cardiac monitoring, glucose and potassium levels and other adverse events. SABA and combination SABA/Ipratropium bromide are equally safe and efficacious as rescue inhalers for patients on combination Fluticasone 500 microg/Salmeterol 50 microg.
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Comparison of nebulized ipratropium bromide with salbutamol vs salbutamol alone in acute asthma exacerbation in children.
Watanasomsiri, A, Phipatanakul, W
Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology. 2006;(5):701-6
Abstract
BACKGROUND Despite multiple doses of beta2-agonists in the treatment of acute asthma exacerbation, significant residual airways obstruction often remains. OBJECTIVE To determine whether the addition of inhaled ipratropium bromide to salbutamol provides improvement in lung function and clinical asthma symptoms in young children with acute asthma exacerbation. METHODS This study was a prospective, double-blind randomized control trial of children aged 3 to 15 years who presented with an acute asthma exacerbation at the emergency department or outpatient clinic of Thammasat University Hospital, Pathumthani, Thailand, between September 2001 and February 2003. Subjects were randomized to receive 3 doses of nebulized salbutamol mixed with isotonic sodium chloride solution (control) or ipratropium bromide (treatment) every 20 minutes. Additional doses of salbutamol were given every 30 minutes as needed. Asthma outcome measures were evaluated 40, 70, 100, and 120 minutes after baseline. Primary outcomes were the differences in percent change in asthma clinical score and percent change in peak expiratory flow rate (PEFR) from baseline. Secondary outcomes included change in percent predicted PEFR. RESULTS Of 74 children randomized and enrolled in the trial, 71 had complete data for analysis. Thirty-three children were in the control group and 38 were in the treatment group. Both the percent change in PEFR and the change in percent predicted PEFR at any time were higher in the treatment group, but these findings were not statistically significantly different. The number of subjects with at least a 100% percent predicted PEFR at any time point was greater in the treatment group. CONCLUSION Although this study did not demonstrate a significant advantage in clinical score and PEFR, the trend toward additional effect of ipratropium bromide was consistent with previous studies.
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Respimat Soft Mist inhaler versus hydrofluoroalkane metered dose inhaler: patient preference and satisfaction.
Schürmann, W, Schmidtmann, S, Moroni, P, Massey, D, Qidan, M
Treatments in respiratory medicine. 2005;(1):53-61
Abstract
INTRODUCTION In addition to offering favorable pharmaceutical performance, an ideal inhaler should be well accepted by patients, as this may facilitate compliance. We report a study that specifically assessed inhaler preference in patients with obstructive lung disease after treatment with ipratropium bromide/fenoterol hydrobromide (Berodual delivered via either Respimat Soft Mist Inhaler (SMI) or hydrofluoroalkane metered dose inhaler (HFA-MDI). METHODS Patients with COPD, asthma or mixed disease were randomized to receive ipratropium bromide/fenoterol hydrobromide 20/50 microg via Respimat SMI or 40/100 microg via HFA-MDI for 7 weeks each, in a crossover design. Patients were trained in inhaler use and given < or =5 attempts to demonstrate satisfactory technique. At the end of each treatment period, patients completed a 15-item satisfaction questionnaire, and inhaler technique was re-tested. On study completion, patients were asked which inhaler they preferred and they rated their willingness to continue using each inhaler. Clinical efficacy outcomes were measured by diary card to check whether switching inhaler affected efficacy. RESULTS In total, 245 patients were randomized and 224 used both inhalers within their respective treatment periods. Of 201 patients expressing a preference, 162 (81%) preferred Respimat SMI and 39 (19%) preferred HFA-MDI (p < 0.001). Patients would rather continue using Respimat SMI than HFA-MDI (p < 0.001). Mean scores for 13 of the 15 satisfaction questions were significantly higher for Respimat SMI than HFA-MDI (p < 0.05); in addition, the total score was also significantly higher for Respimat SMI (p < 0.001). Most patients (217/224; 97%) were judged to have good technique with Respimat SMI after 7 weeks' use. Differences in efficacy measures between the devices were not significant. CONCLUSION These data indicated that a large majority of patients preferred Respimat SMI to HFA-MDI.
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Standard dose of inhaled albuterol significantly increases QT dispersion compared to low dose of albuterol plus ipratropium bromide therapy in moderate to severe acute asthma attacks in children.
Coskun, S, Yuksel, H, Tikiz, H, Danahaliloğlu, S
Pediatrics international : official journal of the Japan Pediatric Society. 2001;(6):631-6
Abstract
BACKGROUND Beta-2 agonist therapy has previously shown to increase the QT dispersion (QTd) in asthmatic patients and increased QTd has been well documented in association with cardiac arrhythmias and sudden death. However, the data concerning the effect of low doses of beta-2 agonist therapy in combination with the anticholinergic agents to potentiate bronchodilatation on QTd in asthmatic children are limited. The objectives of this study was to investigate the changes on QTd during both the standard dose of nebulized albuterol therapy and low dose nebulized albuterol plus inhaled ipratropium therapyn to assess the potential arrhythmogenic risk of these two treatment strategies in children with acute asthmatic attacks. METHODS Forty-three children with the diagnosis of moderate to severe acute asthma were enrolled in the study. Standard dose of nebulized albuterol therapy (0.15 mg/kg) were administered to 20 patients (group 1) and low dose of nebulized albuterol (0.075 mg/kg) plus nebulized ipratropium bromide therapy (250 microg/dose) were given to the remaining 23 patients (group 2). Respiratory distress score, peak expiratory flow rate, arterial blood pressure, O2 saturation, serum potassium and urea nitrogen levels were studied and QT interval parameters were measured from the standard 12-lead electrocardiograms at baseline and after treatment. RESULTS Significant improvement was achieved in respiratory distress score and peak expiratory flow rate after three dose inhalation. No significant difference was observed between the pre and post-treatment values of serum potassium, blood urea nitrogen, O2 saturation and arterial blood pressure values. The evaluation of the corrected QTd (QTcd) showed that while there was no statistical difference in the pre and post-treatment values in group 2 (30.4+/-3.1 msn vs 32.1+/-3.9 msn), QTcd was found to be significantly increased in group 1 after treatment (29.0+/-3 msn vs 40.6+/-5.1 msn, P<0.0001). CONCLUSION The data of the present study suggest that the increase of the QTd is more prominent with the use of a standard dose of albuterol compared to low dose albuterol plus ipratropium therapy. Therefore, it may be concluded that a low dose of albuterol plus ipratropium bromide therapy may be preferred to avoid rhythm disturbances in asthmatic children.
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Comparison of the safety of drug delivery via HFA- and CFC-metered dose inhalers in CAO.
Huchon, G, Hofbauer, P, Cannizzaro, G, Iacono, P, Wald, F
The European respiratory journal. 2000;(4):663-9
Abstract
The objective of this study was to compare the long-term safety of a fixed combination of fenoterol hydrobromide (50 microg) and ipratropium bromide (20 microg) delivered using a metered dose inhaler (MDI) formulated with a non-chlorinated propellant, hydrofluoroalkanel34a (HFA-MDI), with delivery using the conventional chlorofluorocarbon propellant (CFC-MDI, Berodual/Bronchodual). The study was designed according to Safety Assessment of Marketed Medicines (SAMM) guidelines, to reflect as far as possible the use of MDls under normal prescribing conditions. Two thousand and twenty-seven patients with chronic airways obstruction (CAO) were enrolled from 99 centres in France, 95 centres in Germany and 24 centres in Italy. Following a 2-week run-in period, patients were randomized on a 2:1 basis (1,348 patients to HFA-MDI, 679 patients to CFC-MDI) to receive a flexible dose regimen of the combination (2 puffs, 2-4 times a day, as prescribed by the investigator) during a 12-week open label phase. The overall incidence of adverse events was comparable between both groups. In addition, the incidence of respiratory side effects was also similar, with CAO exacerbations or bronchitis the most frequently recorded events. The safety profile of the HFA formulation was comparable to those of the marketed CFC-MDIs used in Germany and France/Italy. No clinically significant differences were detected between HFA134a or CFC driven inhalers on the switch from CFC- to HFA-MDI (2 weeks before randomisation versus 2 weeks after randomization). There was a trend for taste complaints to be reported more frequently by patients in the HFA-MDI group (0.7% before randomization versus 3.4% after randomization). This, however, was an expected finding as the HFA134a formulation does have a different taste to the CFC formulation. No difference between formulations was observed in the incidences of coughing or paradoxical bronchospasm. The incidence of falls in FEV1 >15% within 15 min following inhalation at each of the clinic visits was 1.2% for both CFC- and HFA-MDIs. In conclusion, administration of a fenoterol/ipratropium bromide combination via hydrofluoroalkane-metered dose inhaler is as safe as delivery by the currently available chlorofluorocarbon-metered dose inhaler, in an extended population of patients with CAO under normal prescribing conditions.