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Biomedical subjects

A D D'Urzo

Publications and source records attributed to A D D'Urzo.

At least 19 recordsLinked to original sources
PubMed2005

Maintenance of asthma control by once-daily inhaled ciclesonide in adults with persistent asthma.

BACKGROUND: Inhaled corticosteroids (ICS) are recommended therapy for persistent asthma, although side effects can limit appropriate use. Ciclesonide, a novel ICS, is activated in the lung, thereby reducing systemic activity and side effects. This 12-week, double-blind, randomized, parallel-group, placebo-controlled study evaluated the efficacy and safety of ciclesonide in adults with persistent asthma. METHODS: After a 2-week baseline period in which current ICS treatment was continued, 329 patients were randomized to receive ciclesonide 160 microg (n = 107) or 640 microg (n = 112) (ex-actuator doses, equivalent to 200 and 800 microg ex-valve, respectively), or placebo (n = 110) once daily in the morning. Efficacy was monitored by asthma symptom scores, rescue medication use, morning and evening peak expiratory flow (PEF) measurements, spirometry, and probability of study completion without experiencing lack of efficacy. RESULTS: Morning PEF remained stable with either ciclesonide dose but decreased with placebo; the differences were significant (P < 0.0001) for both ciclesonide doses vs placebo. The forced expiratory volume in 1 s and forced vital capacity decreased significantly with placebo (P < 0.005), but were unchanged with ciclesonide. Lack of efficacy was significantly greater for patients switched to placebo (63%) than it was for those treated with ciclesonide 160 microg (30%) (P < 0.0001 vs placebo) or ciclesonide 640 microg (31%) (P < 0.0001 vs placebo). There were no significant differences between the two tested doses of ciclesonide with respect to efficacy and safety. Serum and 24-h urine cortisol were unaffected by ciclesonide treatment. Both doses of ciclesonide were well tolerated with no cases of oral candidiasis. CONCLUSION: Ciclesonide (160 or 640 microg) once daily in the morning effectively maintains asthma control, does not affect cortisol levels, and has an adverse event profile comparable with placebo in adults with primarily mild to moderate asthma.

Administration, Inhalation↗
PubMed2001

Effectiveness and safety of salmeterol in nonspecialist practice settings.

STUDY OBJECTIVES: To evaluate the effectiveness and safety of inhaled salmeterol in patients managed in nonspecialist practice settings. DESIGN: A randomized, double-blind, 6-month, parallel-group study involving 253 centers. SETTING: Primarily nonspecialist practices (n = 232). PATIENTS: A total of 911 subjects (417 men; 494 women) who met American Thoracic Society asthma criteria were enrolled and randomized to treatment with either twice-daily salmeterol aerosol (50 microg; n = 455) or matching placebo twice daily (n = 456). Both groups were allowed to take salbutamol as needed. All subjects were previously treated with anti-inflammatory maintenance therapy that was continued throughout the study. MEASUREMENTS AND RESULTS: The primary outcome variable was the proportion of subjects with serious asthma exacerbations defined as an exacerbation requiring hospitalization, emergency department visit, or use of prednisone during the treatment period. A total of 712 subjects competed the study. There was no significant difference in the proportion of subjects experiencing serious exacerbations between the salmeterol and placebo groups (20.8% vs 20.9%, respectively; p = 0.935; power > 88%). Peak expiratory flow was significantly higher in the salmeterol group (398 L/min vs 386 L/min for placebo; p < 0.01). Median daily use of salbutamol was two inhalations for the salmeterol group and three inhalations for placebo (p < 0.001). The proportion of subjects sleeping through the night was significantly higher in the salmeterol group (74%) as compared to placebo (68%; p = 0.028). CONCLUSIONS: Salmeterol treatment is effective in subjects typically cared for in the primary-care setting and does not increase the frequency of severe exacerbations.

Acute Disease↗
PubMed2001

In patients with COPD, treatment with a combination of formoterol and ipratropium is more effective than a combination of salbutamol and ipratropium : a 3-week, randomized, double-blind, within-patient, multicenter study.

STUDY OBJECTIVES: To compare the efficacy of adding formoterol or salbutamol to regular ipratropium bromide treatment in COPD patients whose conditions were suboptimally controlled with ipratropium bromide alone. DESIGN: A randomized, double-blind, double-dummy, two-period, crossover clinical trial. SETTING: Twenty-four clinics and university medical centers in nine countries. PATIENTS: One hundred seventy-two patients with baseline FEV(1) < or = 65% predicted, with FEV(1) reversibility to salbutamol not exceeding the normal variability of the measurement, and symptomatic despite regular treatment with ipratropium bromide. INTERVENTIONS: Each patient received two treatments in random order: either inhaled formoterol dry powder, 12 microg bid, in addition to ipratropium bromide, 40 microg qid for 3 weeks, followed by salbutamol, 200 microg qid, in addition to ipratropium, 40 microg qid for 3 weeks, or vice versa. MEASUREMENTS AND RESULTS: Efficacy end points included morning premedication peak expiratory flow (PEF) during the last week of treatment (primary end point), the area under the curve (AUC) for FEV(1) measured for 6 h after morning dose on the last day of treatment, and symptom scores (from daily diary recordings). Morning PEF and the AUC for FEV(1) were significantly better for formoterol/ipratropium than for salbutamol/ipratropium (p = 0.0003 and p < 0.0001, respectively). The formoterol/ipratropium combination also induced a greater improvement in mean total symptom scores (p = 0.0042). The safety profile of the two treatments was comparable. CONCLUSIONS: In COPD patients requiring combination bronchodilator treatment, the addition of formoterol to regular ipratropium treatment is more effective than the addition of salbutamol.

Adult↗
PubMed2000

Leukotriene-receptor antagonists. Role in asthma management.

OBJECTIVE: To examine the role of leukotriene-receptor antagonists (LTRAs) in management of asthma. QUALITY OF EVIDENCE: Most data were derived from randomized, double-blind, controlled trials. MAIN MESSAGE: Leukotrienes appear to have an important role in the pathophysiology of asthma, including airway inflammation. Leukotriene-receptor antagonists are effective in improving asthma control end points, such as allergen, ASA, and exercise challenge, in clinical models of asthma. In chronic asthma, LTRA administration reduces asthma symptoms and rescue beta 2-agonist use, changes that are paralleled by improvements in lung function. Both zafirlukast and montelukast decrease circulating levels of eosinophils and could have other useful anti-inflammatory properties. Administration of LTRAs allows doses of inhaled corticosteroids to be reduced. Currently available LTRAs are free of serious side effects and are available as oral formulations. CONCLUSIONS: Leukotriene-receptor antagonists belong to a new class of asthma medication. While inhaled corticosteroids remain first-line therapy for managing chronic asthma, LTRAs should be considered for patients with ASA-sensitive asthma; as adjunct therapy when low to moderate doses of inhaled steroid alone provide incomplete control; or as adjunct therapy to allow reduction in doses of inhaled corticosteroids.

Acetates↗
PubMed1997

Long-acting beta 2-agonists. Role in primary care asthma treatment.

OBJECTIVE: To examine the efficacy of long-acting beta 2-agonists and their role in primary care asthma management and to review briefly the pharmacology of these agents. QUALITY OF EVIDENCE: Most data presented were derived from randomized, double-blind, placebo-controlled trials. Studies were selected for relevance to asthma management in primary care. MAIN FINDINGS: Long-acting beta 2-agonist use is associated with improvements in both objective and subjective measures of asthma control. At present no evidence suggests that long-acting beta 2-agonists have anti-inflammatory potential. While salmeterol has a longer duration of action than short-acting beta 2-agonists, its onset of action is slower. Salmeterol and formoterol, therefore, should not be used for relief of acute bronchospasm. CONCLUSION: Long-acting beta 2-agonists could be useful for treating asthma in primary care, particularly for controlling symptoms of nocturnal asthma and exercise-induced asthma and for providing convenient maintenance therapy for patients who require regular use of short-acting beta 2-agonists despite concomitant use of optimal doses of inhaled anti-inflammatory medication.

Adrenergic beta-Agonists↗
PubMed1996

The accuracy of a handheld portable spirometer.

BACKGROUND: Objective measurement of lung function is considered essential in the management of patients with asthma and COPD. Many primary care practitioners lack the means necessary to obtain these measurements conveniently. To meet this need, electronic spirometers, offering portability, ease of operation, and timesaving readout options have been introduced. We compared the accuracy of a typical pneumotachograph-based device with a conventional volume displacement spirometer. METHODS: We compared indexes of pulmonary function (FVC, FEV1, mean forced expiratory flow during the middle half of FVC, [FEF25-75%], and peak expiratory flow rate [PEFR]) measured by the handheld device with those measured by a conventional spirometer in 75 white subjects (33 men, 42 women) with a median age of 43 years (22 to 77 years) who were either healthy or were referred to the pulmonary function laboratory of a large tertiary care teaching hospital. The order of the instrument tested first was randomized and the patients were blinded to which instrument was being studied. RESULTS: There was a linear relationship between instruments for all indexes measured (r = 0.97, 0.98, 0.94, 0.94 for FVC, FEV1, FEF25-75%, and PEFR, respectively, for all p < 0.001). The random error (precision) was within 5% only for FEV1. The mean of the differences between the values obtained using both instruments (the bias) +/- limits of agreement (+/- 2 SD) were 0.06 +/- 0.56 L for FVC (p = NS), 0.2 +/- 0.44 L for FEV1 (p < 0.05), 0.61 +/- 1.26 L/s for FEF25-75% (p < 0.05), and 0.44 +/- 1.9 L/s for PEFR (p < 0.05). CONCLUSION: Our data suggest that measurements obtained using the pneumotachograph device are closely related to those obtained by volume displacement spirometry and that the handheld device may be useful in clinical practice. However, because the limits of agreement are wide and the difference between the two instrument measurements are significant for FEV1, FEF25-75%, and PEFR, the bias between them is not consistent nor is it insignificant. Therefore, the measurements made with the two types of machine cannot be used interchangeably.

Adult↗