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Results for “randomized crossover trial”

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At least 271 records · Page 15Linked to original sources

PubMed1991

Caffeine consumption decreases the response to bronchoprovocation challenge with dry gas hyperventilation.

OBJECTIVE: To determine whether caffeine consumption affects bronchoprovocation challenge (BPC). DESIGN: A prospective, double-blind, placebo-controlled, randomized, crossover trial. PATIENTS: Eleven nonsmoking men, aged 18 to 42 years, with normal baseline spirometry and evidence of exercise-induced bronchospasm. INTERVENTION: On three separate test days, each individual received, in random order, either placebo, 5 mg/kg caffeine, or 10 mg/kg caffeine, and then underwent BPC with eucapnic voluntary hyperventilation (EVH). RESULTS: Caffeine (10 mg/kg) significantly reduced bronchoconstriction compared to placebo (p = 0.02). The reduction in bronchoconstriction correlated with the serum level of caffeine (p = 0.014). CONCLUSIONS: Caffeine decreases bronchoconstriction due to EVH. Caffeine should be eliminated from diet prior to BPC.

Adolescent↗

PubMed1995

Dual-chamber pacing with a short atrioventricular delay in congestive heart failure: a randomized study.

OBJECTIVES: This prospective study assessed the initial hemodynamic effects and long-term clinical benefits of dual-chamber pacing with a short atrioventricular (AV) delay in patients with chronic heart failure who had no traditional indication for pacemaker implantation. BACKGROUND: Dual-chamber pacing with a short AV delay has been proposed as a nonpharmacologic treatment for drug-refractory heart failure. Both initial and long-term hemodynamic as well as functional benefits have been reported. All previous studies have used an AV delay of 100 ms. Despite encouraging results, these previous studies have been anecdotal and uncontrolled. METHODS: This double-blind, randomized, crossover trial included 12 subjects with chronic congestive heart failure despite optimal medical therapy. Patients were required to be in sinus rhythm with no evidence of significant bradyarrhythmias. On the day after implantation of a dual-chamber pacemaker, invasive hemodynamic measurements were made at varying AV delays between 100 and 200 ms. Patients were then randomized to either dual-chamber pacing with a 100-ms AV delay or backup mode (VVI at 40 beats/min). After 4 to 6 weeks, crossover to the other pacing mode was programmed. RESULTS: Hemodynamic measurements on the day after pacemaker implantation demonstrated no benefit of pacing with any AV delay compared with intrinsic conduction. At the optimal AV interval for each patient, neither cardiac output (4.5 +/- 1.5 vs 4.7 +/- 1.6 liters/min [mean +/- SD]) nor wedge pressure (16 +/- 10 vs 17 +/- 8 mm Hg) improved significantly from baseline measurements during intrinsic conduction. The long-term pacing protocol was completed in nine patients. Ejection fraction was 16 +/- 6% with dual-chamber (VDD mode) pacing and 18 +/- 4% in backup mode (p = NS). No patient had an increase in ejection fraction by > or = 5% with VDD pacing, nor did any patient improve in New York Heart Association functional class with short AV delay dual-chamber pacing. Also, there were no significant reductions in body weight or diuretic requirements during this pacing period. CONCLUSIONS: Dual-chamber pacing with a short AV delay does not improve hemodynamic and clinical status or ejection fraction measured on the day after pacemaker implantation in patients with chronic congestive heart failure. Routine use of pacemaker therapy with a short AV delay aas a primary treatment of heart failure in patients without standard arrhythmic indications is unwarranted.

Aged↗

PubMedDate not supplied

A randomized, controlled trial of two-thumb vs two-finger chest compression in a swine infant model of cardiac arrest [see comment].

BACKGROUND: The American Heart Association (AHA) currently recommends two-finger (TF) chest compression for infants. A previous study demonstrated that two-thumb (TT) with lateral chest wall compression provided significantly higher arterial pressures than did the TF method. Limitations of that study included the lack of an asphyxial model and non-standardized compression forces. OBJECTIVE: To test the hypothesis that TT chest compression generates higher arterial pressures than does the TF method, using an asphyxial model. Also, by standardizing sternal compression force (SCF), the authors sought to show that the increased pressures are the result of thoracic compression. METHOD: The study was a randomized, crossover trial in immature swine weighing 10 kg. Each swine was sedated, anesthetized, paralyzed, intubated, and mechanically ventilated on room air. A femoral arterial catheter was placed. Cardiac arrest was induced by asphyxiation and verified by ECG and pressure tracings. Eleven AHA-certified basic rescuers each randomly performed four 1-minute trials of external chest compressions. Each of the two CPR techniques was performed, with and without feedback of SCF. Compression forces were measured using the Uniforce Sensor System (Force Imaging Technology, Inc., Chicago, IL). During the feedback mode, the rescuers were instructed to maintain sternal pressures at 20-25 psi. During the nonfeedback mode, the rescuers were blinded to the force transducer. All compressions were analyzed for systolic blood pressure (SBP), diastolic blood pressure (DBP), and SCF. Data were analyzed using repeated-measures analysis of variance (RMANOVA) and Tukey multiple comparisons (alpha = 0.05). RESULTS: A total of 2,297 compressions were analyzed. The TT method produced significantly higher SBPs both with (25% increase) and without (57% increase) feedback when compared with the TF. The DBPs were not significantly different. The SCFs were also significantly higher in the two groups with feedback. The SCFs in the TF groups did not reach the standardized value of 20 psi, whereas in the TT groups, both were in the range of 20-25 psi. CONCLUSION: The TT method produced significantly higher SBPs. The authors were unable to demonstrate that the increased SBPs were secondary to the thoracic compression component because the rescuers did not reach the predetermined SCF in the TF groups. In this swine model of infant CPR, TT chest compression is an easier and more effective method.

Animals↗

PubMed1993

Tolerance of hemodialysis: a randomized prospective trial of high-flux versus conventional high-efficiency hemodialysis.

Hemodialysis is frequently complicated by hypotension and associated symptoms. It has been suggested that these symptoms may be related to the biochemical changes caused by cellulosic dialysis membranes. In this study, a prospective randomized crossover trial was conducted comparing the incidence of hypotension and acute symptoms during dialysis with large-surface-area (1.6 m2) cellulosic (cuprophane [CUP]) and noncellulosic (polyacrylonitrile [PAN], AN69) membranes. Dialyzers were used for a single use only. There was no difference in predialysis BUN, predialysis blood pressure, intradialytic weight gain, blood flow, dialysis efficiency (urea reduction), dialysis duration, hematocrit, or erythropoietin dose between the two study phases. When these clinical characteristics were matched, there was no difference in the number of episodes of hypotension (CUP, 19 +/- 3; PAN, 22 +/- 3; P = not significant [NS]). The incidence of symptomatic hypotension, as reflected by the number of episodes of hypotension requiring more than 100 mL of saline for correction, was also not different between study phases (CUP, 10 +/- 1; AN69, 11 +/- 2; P = NS). The incidence of intradialytic symptoms, including emesis, cramping, headache, angina, pruritus, and bronchospasm, was similar during the two study phases (CUP, 11 +/- 2; AN69, 10 +/- 1; P = NS). It was concluded that noncellulosic membranes do not offer any significant advantage over cellulosic membranes in reducing the acute complications of hemodialysis.

Acrylic Resins↗

PubMed2004

Direct comparison of cerebrovascular effects of norepinephrine and dopamine in head-injured patients.

OBJECTIVE: To directly compare the cerebrovascular effects of norepinephrine and dopamine in patients with acute traumatic brain injury. DESIGN: Prospective randomized crossover trial. SETTING: Neurosciences critical care unit of a university hospital. PATIENTS: Ten acutely head-injured patients requiring vasoactive drugs to maintain a cerebral perfusion pressure of 65 mm Hg. INTERVENTIONS: Patients were randomized to start the protocol with either norepinephrine or dopamine. Using an infusion of the allocated drug, cerebral perfusion pressure was adjusted to 65 mm Hg. After 20 mins of data collection, cerebral perfusion pressure was increased to 75 mm Hg by increasing the infusion rate of the vasoactive agent. After 20 mins of data collection, cerebral perfusion pressure was increased to 85 mm Hg and again data were collected for 20 mins. Subsequently, the infusion rate of the vasoactive drug was reduced until a cerebral perfusion pressure of 65 mm Hg was reached and the drug was exchanged against the other agent. The protocol was then repeated. MEASUREMENTS AND MAIN RESULTS: Mean arterial pressure and intracranial pressure were monitored and cerebral blood flow was estimated with transcranial Doppler. Norepinephrine led to predictable and significant increases in flow velocity for each step increase in cerebral perfusion pressure (57.5+/-19.9 cm x sec, 61.3+/-22.3 cm x sec, and 68.4+/-24.8 cm x sec at 65, 75, and 85 mm Hg, respectively; p <.05 for all three comparisons), but changes with dopamine were variable and inconsistent. There were no differences between absolute values of flow velocity or intracranial pressure between the two drugs at any cerebral perfusion pressure level. CONCLUSIONS: Norepinephrine may be more predictable and efficient to augment cerebral perfusion in patients with traumatic brain injury.

Adult↗

PubMed1998

Comparison of antiemetic efficacy of granisetron and ondansetron in Oriental patients: a randomized crossover study.

A double-blind randomized crossover trial was performed to compare the antiemetic efficacy of two 5-HT3 receptor antagonists, granisetron and ondansetron, in Chinese patients receiving adjuvant chemotherapy (cyclophosphamide, methotrexate and 5-fluorouracil) for breast cancer. Twenty patients were randomized to receive chemotherapy with either granisetron on day 1 and ondansetron on day 8 of the first cycle followed by the reverse order in the second cycle, or vice versa. The number of vomiting episodes and the severity of nausea in the first 24 h (acute vomiting/nausea) and the following 7 days (delayed vomiting/nausea) were studied. Acute vomiting was completely prevented in 29 (72.5%) cycles with granisetron and 27 (67.5%) cycles with ondansetron, and treatment failure (>5 vomiting episodes) occurred in two (5%) cycles with each agent (P = NS). Acute nausea was completely controlled in 15 (37.5%) cycles with granisetron and 14 (35%) cycles with ondansetron, whereas severe acute nausea occurred in four (10%) cycles with each agent (P = NS). However, complete response for delayed vomiting was observed in only 21 (52.5%) cycles with granisetron and 22 (55%) cycles with ondansetron (P = NS), and delayed nausea was completely controlled in only 11 (27.5%) and ten (25%) cycles respectively (P = NS). In conclusion, both granisetron and ondansetron are effective in controlling acute nausea and vomiting in Chinese patients, with equivalent antiemetic efficacy. Control of delayed nausea and vomiting is less satisfactory.

Adult↗

PubMed1999

Intermittent compression units for severe post-phlebitic syndrome: a randomized crossover study.

BACKGROUND: Although uncommon, severe post-phlebitic syndrome may be associated with persistent, intractable pain and swelling that interfere with work and leisure activities. This study was performed to determine whether intermittent compression therapy with an extremity pump benefits patients with this condition and, if so, whether the benefit is sustained. METHODS: The study was a randomized crossover trial. Over the period 1990 to 1996, all patients in the clinical thromboembolism program of an Ontario teaching hospital who had a history of deep vein thrombosis and intractable symptoms of post-phlebitic syndrome were recruited into the study. The study involved using an extremity pump twice daily for a total of 2 months (20 minutes per session). The patients were randomly assigned to use either a therapeutic pressure (50 mm Hg) or a placebo pressure (15 mm Hg) for the first month. For the second month, the patients used the other pressure. A questionnaire assessing symptoms and functional status served as the primary outcome measure and was administered at the end of each 1-month period. A symptom score was derived by summing the scores for individual questions. At the end of the 2-month study, patients were asked to indicate their treatment preference and to rate the importance of the difference between the 12 pressures. Treatment was considered successful if the patient preferred the therapeutic pressure and stated that he or she would continue using the extremity pump and that the difference between the therapeutic and placebo pressures was of at least slight importance. All other combinations of responses were considered to represent treatment failure. Patients whose treatment was classified as successful were offered the opportunity to keep the pump and to alter pressure, frequency and duration of pump use to optimize symptom management. In July 1996 the authors contacted all study participants whose treatment had been classified as successful to determine whether they were still using the pump and, if so, whether they were still deriving benefit. RESULTS: In total 15 consecutive patients (12 women and 3 men) were enrolled in the study. The symptom scores were significantly better with the therapeutic pressure (mean 16.5) than with the placebo pressure (mean 14.4) (paired t-test, p = 0.007). The treatment for 12 of the patients (80%, 95% confidence interval 52% to 96%) was considered successful. Of these, 9 patients continued to use the pump beyond the crossover study and to derive benefit. INTERPRETATION: The authors conclude that a trial of pump therapy is worthwhile for patients with severe post-phlebitic syndrome and that a sustained beneficial response can be expected in most such patients.

Adult↗

PubMed1987

A randomized trial of high dose bolus metoclopramide versus low-dose continuous infusion metoclopramide in the prevention of cisplatin-induced emesis.

We compared the antiemetic efficacy of metoclopramide in a bolus low-dose infusion schedule to that of metoclopramide given in a conventional high-dose bolus schedule in a randomized crossover trial. Thirty-two treatment courses in 16 patients receiving cisplatin chemotherapy were evaluable. The metoclopramide regimen was either 2 mg/kg i.v. bolus, then 20 mg/h by infusion for 4 h, or 2 mg/kg i.v. bolus every 2 h for three doses. Dexamethasone 20 mg i.v. and diphenhydramine 50 mg i.v. were also given. Antiemetic efficacy was assessed by a questionnaire. There were no differences in antiemetic efficacy between the metoclopramide regimens. With either program, 75% of patients were emesis-free, 13% had mild symptoms, and 13% had moderate symptoms (greater than two emetic episodes). The infusion metoclopramide regimen was 30% less expensive than the bolus schedule in our pharmacy. Thus, we recommend low-dose metoclopramide infusion as a less expensive, equally effective alternative to high-dose bolus regimens for antiemetic treatment.

Adolescent↗

PubMed2000

A double-blind placebo-controlled crossover trial of intravenous magnesium sulfate for foscarnet-induced ionized hypocalcemia and hypomagnesemia in patients with AIDS and cytomegalovirus infection.

Foscarnet (trisodium phosphonoformate hexahydrate) is an antiviral agent used to treat cytomegalovirus disease in immunocompromised patients. One common side effect is acute ionized hypocalcemia and hypomagnesemia following intravenous administration. Foscarnet-induced ionized hypomagnesemia might contribute to ionized hypocalcemia by impairing excretion of preformed parathyroid hormone (PTH) or by producing target organ resistance. Prevention of ionized hypomagnesemia following foscarnet administration could blunt the development of ionized hypocalcemia. To determine whether intravenous magnesium ameliorates the decline in ionized calcium and/or magnesium following foscarnet infusions, MgSO(4) at doses of 1, 2, and 3 g was administered in a double-blind, placebo-controlled, randomized, crossover trial to 12 patients with AIDS and cytomegalovirus disease. Overall, increasing doses of MgSO(4) reduced or eliminated foscarnet-induced acute ionized hypomagnesemia. Supplementation, however, had no discernible effect on foscarnet-induced ionized hypocalcemia despite significant increases in serum PTH levels. No dose-related, clinically significant adverse events were found, suggesting that intravenous supplementation with up to 3 g of MgSO(4) was safe in this chronically ill population. Since parenteral MgSO(4) did not alter foscarnet-induced ionized hypocalcemia or symptoms associated with foscarnet, routine intravenous supplementation for patients with normal serum magnesium levels is not recommended during treatment with foscarnet.

AIDS-Related Opportunistic Infections↗

PubMed2003

Multisite atrial pacing for atrial fibrillation prevention: where to go from here?

Atrial fibrillation (AF) is a common arrhythmia associated with stroke, increased mortality and with a negative impact on quality of life. Pharmacologic treatments for AF have not provided long-term relief from arrhythmia recurrence. Multi-site atrial pacing was introduced by Daubert and colleagues about 10 years ago for the treatment of severe atrial conduction delays in patients with sick sinus syndrome. They found that this type of atrial stimulation reduced or prevented AF. Multi-site atrial pacing results in reduction of intra-atrial and interatrial conduction differences and diminishes heterogeneity of refractoriness, i.e. atrial resynchronization. Acute electrophysiological studies have shown that biatrial stimulation reduced AF inducibility. The Dutch Dual-site Right Atrial Pacing for Prevention of Atrial Fibrillation study was a prospective randomized crossover trial comparing the recurrences of AF in dual-site right atrial and single-site high right atrial pacing in patients with symptomatic medically refractory AF, without or with minimal structural heart disease. Patients were randomized to initial dual-site pacing (Group I n = 18) or initial single-site (Group II n = 22) pacing. After 6 months or after a study endpoint was reached patients were crossed over to the other pacing modality.Although, the arrhythmia free intervals were longer for dual-site pacing during both treatments periods (Group I 162 +/- 12 and Group II 114 +/- 15 days) compared to single-site pacing (Group I 143 +/- 16 and Group II 97 +/- 10 days) the difference was not statistically significant (p = 0.061). However, the sequence of the randomized treatment periods had a significant effect on outcome (p < 0.02). Event free intervals (AF > 48 hours requiring electrical cardioversion) were longer during dual-site pacing in both groups compared to single-site stimulation but the difference was statistically not significant (p = 0.055) because of treatment interaction (P < 0.05). To establish the clinical benefits of multi-site pacing for the treatment of patients with medically refractory symptomatic AF, additional prospective randomized studies are needed. Trials with a parallel design are necessary to avoid carry-over effects of different stimulation protocols.

Atrial Fibrillation↗

PubMed1982

The run-in period in trial design: a comparison of two non-steroidal anti-inflammatory agents in psoriatic arthropathy.

Psoriatic arthropathy is a relatively uncommon arthritis that exists in a wide variety of clinical forms. These two features of the disease cause problems in the design of clinical trials. In a comparison of two non-steroidal anti-inflammatory agents in this condition we attempted to overcome the difficulties by using a run-in period during which the dosage of one of the trial drugs was adjusted to suit the individual patient. After two weeks on indomethacin (75 mg or 150 mg/day) patients were allocated to four-week periods of indomethacin in the chosen dosage or diclofenac (75 mg or 150 mg/day) in a double-blind randomized crossover trial that used double dummy packaging. Of the 35 patients that entered the study, 19 completed both study groups. No significant differences were observed between the clinical improvements due to both drugs during the course of the study. In general more side-effects were seen during indomethacin treatment, though the study design precluded exact comparison. In a study biased against diclofenac, patient preference was 9/19 for indomethacin, 4/19 for diclofenac and 7/19 expressing no choice. Advantages and disadvantages of the study design are discussed.

Adult↗

PubMed1991

Breathing circuit respiratory work in infants recovering from respiratory failure.

OBJECTIVE: To compare cardiopulmonary function during spontaneous breathing with three continuous-flow breathing circuits. The major difference between these circuits was the degree of flow resistance offered by the exhalation valve. DESIGN: Randomized crossover trial. PATIENTS: Twelve infants less than 12 months of age recovering from respiratory failure of variable etiology. Only patients weighing 3 to 10 kg were studied. INTERVENTIONS: The patients were connected to each respiratory circuit in a random sequence, with 15 min allowed for equilibration before assessment of cardiopulmonary function. Airway pressure (Paw) and FIO2 were maintained unchanged. MEASUREMENTS AND MAIN RESULTS: Ventilation, gas exchange, or circulatory function were not altered significantly by changing the breathing circuit. However, Paw and esophageal pressure fluctuations were altered and were largest during breathing with the circuit that had an exhalation valve with high-flow resistance. The Paw fluctuation recorded while the patient was breathing with the flow-resistor circuit increased with weight and exceeded 2 cm H2O in all patients weighing greater than 4.5 kg. Paw fluctuation could be decreased by greater than 2 cm H2O in ten of 12 patients by using the threshold-resistor circuit. CONCLUSIONS: The results indicate a need for evaluating the characteristics of respiratory circuits used for spontaneous breathing in infants and children, to avoid unnecessary equipment-related increase in respiratory work.

Airway Resistance↗

PubMed2002

Kefir consumption does not alter plasma lipid levels or cholesterol fractional synthesis rates relative to milk in hyperlipidemic men: a randomized controlled trial [ISRCTN10820810].

BACKGROUND: Fermented milk products have been shown to affect serum cholesterol concentrations in humans. Kefir, a fermented milk product, has been traditionally consumed for its potential health benefits but has to date not been studied for its hypocholesterolemic properties. METHODS: Thirteen healthy mildly hypercholesterolemic male subjects consumed a dairy supplement in randomized crossover trial for 2 periods of 4 wk each. Subjects were blinded to the dairy supplement consumed. Blood samples were collected at baseline and after 4 wk of supplementation for measurement of plasma total, low-density lipoprotein, and high-density lipoprotein cholesterol and triglyceride concentrations, as well as fatty acid profile and cholesterol synthesis rate. Fecal samples were collected at baseline and after 2 and 4 wk of supplementation for determination of fecal short chain fatty acid level and bacterial content. RESULTS: Kefir had no effect on total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol or triglyceride concentrations nor on cholesterol fractional synthesis rates after 4 wk of supplementation. No significant change on plasma fatty acid levels was observed with diet. However, both kefir and milk increased (p < 0.05) fecal isobutyric, isovaleric and propionic acids as well as the total amount of fecal short chain fatty acids. Kefir supplementation resulted in increased fecal bacterial content in the majority of the subjects. CONCLUSIONS: Since kefir consumption did not result in lowered plasma lipid concentrations, the results of this study do not support consumption of kefir as a cholesterol-lowering agent.

Adult↗

PubMed2003

Effect of pantoprazole on the course of reflux-associated laryngitis: a placebo-controlled double-blind crossover study.

BACKGROUND: The optimal management of patients with reflux-associated laryngitis is unclear. We performed a placebo-controlled crossover trial in patients with proven reflux disease and associated laryngitis to determine the effect of pantoprazole and to gain information on the natural course of the disease. METHODS: Sixty-two consecutive non-smoking patients with hoarseness and proven laryngitis were examined. Scores with respect to the larynx and for subjective complaints were determined and 24-h pH-metry to assess acid reflux in the lower oesophagus and pharynx was performed. Patients with pathologic reflux were given the chance to enter a double-blinded randomized crossover trial with pantoprazole 40 mg b.i.d. and placebo for a duration of 3 months each, separated by a 2-week washout period. RESULTS: Twenty-four of 62 patients showed pathological reflux; 21 patients were included in the study and 14 concluded all parts of the study. Both pantoprazole and placebo resulted in a marked improvement in laryngitis scores (decrease of 8.0 +/- 1.4 versus 5.6 +/- 2.6; no significant difference between the 2 treatments) and symptoms after the first 3 months (decrease of oesophageal symptom score of 2.2 +/- 1.4 versus 5.4 +/- 2.8; decrease of laryngeal scores of 8.3 +/- 3.6 versus 10.3 +/- 3.9; also no significant difference between the 2 treatments). A second pH-metry 2 weeks thereafter proved the persistence of reflux in most of these patients. Switching to pantoprazole led to a further improvement of scores. In the group switched to placebo there was recurrence only in a minority of patients. CONCLUSIONS: The self-limited nature of reflux-associated laryngitis in non-smokers is largely underestimated. Laryngitis improves despite the persistence of reflux. Pantoprazole may be helpful especially in relieving acute symptoms, but the advantage of long-term treatment over placebo has been greatly overestimated.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed1992

Dose-ranging pharmacokinetic study of ciprofloxacin after 200-, 300-, and 400-mg intravenous doses.

OBJECTIVE: To assess the pharmacokinetics and tolerance of ciprofloxacin after the administration of single intravenous doses of 200, 300, and 400 mg. DESIGN: Double-blind, three-period, randomized, crossover trial. SETTING: Private, university-affiliated, hospital-based, clinical research center. PATIENTS: Normal healthy male volunteers, 18-40 years of age. INTERVENTIONS: Subjects received 200-, 300-, and 400-mg single intravenous doses of ciprofloxacin via 30-minute infusions in random sequence. MAIN OUTCOME MEASURES: Serum ciprofloxacin concentrations were determined by HPLC after each dose and the results were used to derive pharmacokinetic parameters. Tolerance was assessed by reported and observed adverse events, urine microscopic examinations for crystals, and examination of intravenous infusion sites. RESULTS: The mean area under the time curve (AUC) values displayed linearity with respect to the administered dose. No statistical differences were observed in total body clearance, steady-state volume of distribution, or elimination half-life with respect to dose administered. The mean total body clearance, steady-state volume of distribution, or elimination half-life ranged from 36 to 41 L/h, 146 to 169 L, and 3.5 to 3.7 h for the 200-, 300-, and 400-mg doses, respectively. Adverse effects, including venous irritation (four subjects) and crystalluria (two subjects), were mild and did not require withdrawal of any subject from the study. CONCLUSIONS: Intravenous ciprofloxacin in doses ranging from 200 to 400 mg demonstrated linear pharmacokinetics. These single doses were well tolerated, although cases of transient venous irritation and crystalluria were observed.

Adolescent↗

PubMed2004

Efficacy and safety performance of the Innovo insulin doser.

Innovo (Novo Nordisk A/S, Hillerød, Denmark) is a new insulin injection system that offers built-in memory and a large, clear display to provide patients with more control during insulin injections. The aim of this trial was to compare the efficacy and safety of Innovo and NovoPen 3 (Novo Nordisk A/S) in patients experienced in using insulin injection devices. Participants included 217 adults who had used NovoPen 3 or other durable pen systems for at least 6 months. This multinational, multicenter, open, randomized crossover trial comprised two treatment periods of equal duration (6 or 12 weeks). Efficacy was determined using hemoglobin A1c (HbA1c) and blood glucose concentrations, and safety parameters were the frequency and severity of hypoglycemic events. Daily insulin dose was also recorded. The effect of device type on change in HbA1c was not significant. The adjusted treatment differences between Innovo and NovoPen 3 were 0.088% [confidence interval (CI), -0.031 to 0.208%] and 0.005% (CI, -0.086 to 0.096%) for the German and Dutch/Austrian sites, respectively. Blood glucose profiles were not affected significantly by device type. Treatment differences were 0.04 mmol/L (CI, -0.57 to 0.48 mmol/L) and 0.21 mmol/L (CI, -0.13 to 0.55 mmol/L) for the German and Dutch/Austrian sites, respectively. Innovo and NovoPen 3 did not differ with regard to safety: There were no differences in numbers of various types of adverse events, or in percentage of patients experiencing one or more hypoglycemic event. This study demonstrates that the Innovo insulin doser is as safe and efficacious as NovoPen 3.

Adult↗

PubMed1999

A pilot controlled clinical trial of ABT-418, a cholinergic agonist, in the treatment of adults with attention deficit hyperactivity disorder.

OBJECTIVE: Despite the increasing recognition of attention deficit hyperactivity disorder (ADHD) in adults, there is a paucity of controlled pharmacological trials. Recent reports have suggested the potential usefulness of cholinergic agents for ADHD. To this end, the authors completed a controlled study of ABT-418, a novel cholinergic activating agent, for the treatment of adults with ADHD. METHOD: This was a double-blind, placebo-controlled, randomized, crossover trial that compared a transdermal patch of ABT-418 (75 mg/day) to placebo in adults who met DSM-IV criteria for ADHD. There were two 3-week treatment periods separated by 1 week of washout. RESULTS: Of the 32 subjects enrolled in the study (88% were men; mean age = 40 years, SD = 9), 29 completed the study. At the endpoint of each active arm (last observation carried forward), a significantly higher proportion of subjects was considered improved while receiving ABT-418 than while receiving placebo (40% versus 13%). Similarly, at endpoint there was a significantly greater reduction in ADHD symptom checklist scores (28% versus 15%). Symptoms reflective of attention, and subjects with less severe ADHD, responded more robustly to ABT-418. Treatment with ABT-418 was relatively well tolerated; dizziness and nausea were the most frequently reported adverse effects. CONCLUSIONS: The results of this investigation indicate that ABT-418, a nicotinic analog, may be a potentially useful agent for the treatment of ADHD.

Administration, Cutaneous↗

PubMed1986

The use of a single daily theophylline dose and metered-dose albuterol in asthma treatment.

Sustained-release, 24-hour theophylline preparations have been formulated and may provide for convenient once-a-day dosing, although the use of such products in clinical asthma has yet to be fully established. This study compared single daily versus twice daily dosing with a 24-hour theophylline, Uniphyl, in asthma and further evaluated for the additional effect of metered-dose albuterol on each theophylline regimen. Twenty-eight patients with asthma were enrolled in this randomized crossover trial. Before enrollment, all demonstrated at least a 15% improvement in FEV1 after a beta-adrenergic aerosol and had serum theophylline levels ranging from 5 to 20 micrograms/ml with a predetermined 800 mg daily dose of Uniphyl. The patients were then randomly entered into four treatment regimens for one week each: Uniphyl, 800 mg four times a day (qd); metered-dose albuterol, active, 180 micrograms four times a day (qid); Uniphyl, 400 mg twice daily; metered-dose albuterol, active, 180 micrograms qid; Uniphyl, 800 mg qd; placebo, two puffs qid; and Uniphyl, 400 mg twice daily; placebo, two puffs qid. On the morning of the seventh day of each treatment regimen, pulmonary functions and a trough serum theophylline level were measured. The patient then received the same medication that he had taken for the preceding week. Spirometry was measured hourly, and a serum theophylline level was measured 6 hours later. The daily symptom scores, peak flow values, and pulmonary functions on the test day were similar with either single or twice daily Uniphyl dosing. Routine administration of albuterol by metered dose did not enhance asthma control in an unequivocal fashion.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗