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Results for “randomized crossover trial”

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PubMed2001

Erythromycin increases plasma concentrations of alpha-dihydroergocryptine in humans.

OBJECTIVE: Our objective was to investigate the potential for relevant pharmacotherapeutic interaction between cytochrome P4503A4 (CYP3A4)-inhibiting agents such as erythromycin and the dopamine agonist alpha-dihydroergocryptine (DHEC). METHODS: The study was carried out as a single-center, controlled, nonblinded, 2-way crossover clinical trial with randomly allocated period-balanced sequences, investigating two treatments of a single oral dose of 10 mg DHEC (on the morning of day 1), once administered alone (reference), once along with a 4-day treatment (days -2 to 1) of 500 mg erythromycin 3 times daily. Periods were separated by a washout of at least 14 days. Nine healthy white male volunteers, 22 to 42 years old, with a body weight range of 58 to 90 kg (body mass index, 20.2-25.1 kg x m(-2)) began the study. One subject discontinued prematurely, and 8 concluded the study in accordance with the study protocol. RESULTS: The plasma and urinary pharmacokinetics of DHEC and its metabolites were characterized by a large variability. Concomitant treatment with erythromycin led to respective increases of 9.5 (95% confidence interval [CI], 6.5 to 13.9) and 16.5 (95% CI, 8.7 to 31.5) times the maximum observed plasma drug concentration and the area under the time course of the plasma concentrations up to the last quantifiable concentration after dosing of unchanged DHEC (determined by radioimmunoassay). The 24-hour urinary excretion was on average 11 times larger (95% CI, 5.9 to 20.7). Qualitatively similar findings were recorded for the total of DHEC plus metabolites (as determined by enzyme immunoassay). CONCLUSIONS: The concomitant use of erythromycin or similarly CYP3A4-inhibiting agents along with direct dopaminergic agonists such as the ergoline DHEC may cause a clinically relevant increase in pharmacokinetic exposure, which may induce exaggerated dopaminergic effects.

Administration, Oral↗

PubMed1991

Angiotensin-converting enzyme inhibition and physical training in heart failure.

A total of 12 patients (mean age +/- SEM 63 +/- 2.6 years) with moderate to severe heart failure (ejection fraction = 23 +/- 3.2%) were included in a placebo-controlled crossover trial. Patients were randomly allocated to 4 periods of 6 weeks each: placebo, placebo and physical training, lisinopril 10 mg daily, and lisinopril and physical training. The exercise time increased from 13.6 +/- 0.9 min with placebo to 15 +/- 1 min with training alone, and to 16.1 +/- 0.7 min with lisinopril and training. With lisinopril alone there was a non-significant increase in exercise time, to 14.5 +/- 0.6 min. Improvements in exercise time were accompanied by a similar increase in peak oxygen consumption. Overall, the most significant improvements in symptoms and indices of cardiorespiratory fitness were achieved with a combination of lisinopril and training. Thus physical training is not only a useful adjunct to the existing medical therapy for heart failure, but it may also provide symptomatic benefits in its own right.

Aged↗

PubMed2004

Bradykinin contributes to the systemic hemodynamic effects of chronic angiotensin-converting enzyme inhibition in patients with heart failure.

BACKGROUND: Bradykinin is an endogenous vasodilator that may contribute to the systemic effects of angiotensin-converting enzyme (ACE) inhibitor therapy. Using B9340, a bradykinin receptor antagonist, we determined the contribution of bradykinin to the systemic hemodynamic effects of long-term ACE inhibition in patients with chronic heart failure. METHODS AND RESULTS: Fourteen patients with heart failure received enalapril (10 mg twice daily) or losartan (50 mg twice daily) in a randomized double-blind crossover trial. After 6 weeks treatment, patients underwent right heart catheterization and were randomized to an intravenous infusion of B9340 (2 to 20 microg/kg per minute) or saline placebo. After B9340 infusion in patients treated with enalapril, mean arterial pressure (+5.2 mm Hg), systemic vascular resistance (+315 dynes x s/cm5), pulmonary arterial wedge pressure (-1.4 mm Hg), and mean pulmonary arterial pressure (-1.3 mm Hg) were greater compared with losartan (P<0.005, P=0.07, P<0.0001, and P<0.05 respectively) or placebo infusion (P< or =0.005 for all). There was a reduction in cardiac output after B9340 with enalapril compared with placebo (P<0.001) but not losartan. CONCLUSIONS: Bradykinin contributes to the systemic hemodynamic effects of long-term ACE inhibition in patients with heart failure. This mechanism may explain the apparent clinical differences between ACE inhibitors and angiotensin receptor blockers in the treatment of heart failure.

Aged↗

PubMed2004

Multi-compartment medication devices and patient compliance.

Multi-compartment medication compliance devices are widely used in primary care. The aim of this review is to reveal whether they are effective in promoting adherence among non-adherent adults living at home. Searches were undertaken using two electronic databases (Medline (1966-2003) and International Pharmaceutical Abstracts (1970-2002)). Only randomized controlled trials (including crossover studies) were included in the review. Participants had to be non-institutionalized adults receiving one or more prescription medicines each day and displaying problems with adherence. Studies had to compare multi-compartment medication compliance devices to standard packaging and outcome measures and to include either pill counts, biological assays and/or clinical response. Articles were selected if they described a follow up period of at least three months and demonstrated that over 80% of participants had completed the trial. Two studies were identified that met the criteria, reporting data on a total of 148 patients. The findings from the first study found diabetic patients receiving medication in a compliance device demonstrated better glucose control than patients receiving medication in standard packaging. The second study found compliance devices had no impact on blood pressure control in hypertensive patients. Further research needs to be conducted to assess the effectiveness of multi-compartment medication compliance devices in promoting adherence among non-adherent adults living at home.

Adult↗

PubMedDate not supplied

Efficacy of gabapentin in treating chronic phantom limb and residual limb pain.

Twenty-four adults with phantom limb pain (PLP) and/or residual limb pain (RLP) participated in a double-blind crossover trial. Participants were randomly assigned to receive gabapentin or placebo and later crossed over to the other treatment, with a 5-week washout interval in which they did not receive medication. Gabapentin was titrated from 300 mg to the maximum dose of 3,600 mg. Measures of pain intensity, pain interference, depression, life satisfaction, and functioning were collected throughout the study. Analyses revealed no significant group differences in pre- to posttreatment change scores on any of the outcome measures. More than half of the participants reported a meaningful decrease in pain during the gabapentin phase compared with about one-fifth who reported a meaningful decrease in pain during the placebo phase. In this trial, gabapentin did not substantially affect pain. More research on the efficacy of gabapentin to treat chronic PLP and RLP is needed.

Adult↗

PubMed2001

Beneficial effects of a soy-based dietary supplement on lipid levels and cardiovascular risk markers in type 2 diabetic subjects.

OBJECTIVE: Consumption of soy protein has recently been shown to improve the blood lipid levels in nondiabetic subjects. The purpose of this study was to evaluate if a dietary supplement of soy protein, isoflavones, and cotyledon fiber (Abalon) affects cardiovascular risk markers, blood glucose, and insulin levels in type 2 diabetic subjects. RESEARCH DESIGN AND METHODS: Twenty type 2 diabetic subjects participated in a crossover trial. They were randomized to double-blind supplementation for 6 weeks with Abalon (soy protein [50 g/day] with high levels of isoflavones [minimum 165 mg/day] and cotyledon fiber [20 g/day]) or placebo (casein [50 g/day] and cellulose [20 g/day]), separated by a 3-week wash-out period. RESULTS: The results are expressed as means +/- SD. The percentage mean treatment difference between Abalon and placebo demonstrated significantly lower mean values after Abalon for LDL cholesterol (10 +/- 15%, P < 0.05), LDL/UHDL ratio (12 +/- 18%, P < 0.05), apolipoprotein (apo) B100 (30 +/- 38%, P < 0.01), triglycerides (22 +/- 10%, P < 0.05), and homocysteine (14 +/- 21%, P < 0.01), whereas the total cholesterol value tended to be less significant but still lower (8 +/- 15%, P < 0.08). No change occurred in HDL cholesterol, apo B100/apo A1 ratio, plasminogen activator inhibitor 1, factor VIIc, von Willebrand factor, fibrinogen, lipoprotein(a), glucose, HbA1c, or 24-h blood pressure. CONCLUSIONS: These results indicate beneficial effects of dietary supplementation with Abalon on cardiovascular risk markers in type 2 diabetic subjects. This improvement is seen even in individuals with near-normal lipid values.

Aged↗

PubMed1983

A double blind crossover study of carprofen and indomethacin in patients with rheumatoid arthritis.

Twenty-eight patients with definite or classic rheumatoid arthritis were studied in a four-month double blind crossover trial. Patients were randomly divided into two groups, and received either carprofen, 300 mg/day, or indomethacin, 75 mg/day, for a period of two months, and then the other medication for a further two months. The classic procedures and measurements for evaluation of activity of rheumatoid arthritis were used. Laboratory tests were also carried out to assess toxicity. Both drugs were effective for the long term treatment of rheumatoid arthritis, and there were no statistically significant differences between the carprofen and indomethacin periods, or between groups. Although the incidence of adverse reactions was similar for both drugs, cutaneous symptoms were more frequent with carprofen than with indomethacin, whereas gastrointestinal and central nervous system reactions were found more often with indomethacin.

Adult↗

PubMed1999

[Clinical study of anastrozole in the treatment of postmenopausal women with advanced breast cancer].

OBJECTIVE: To study the effect and adverse reactions of anastrozole in the treatment of postmenopausal women with advanced breast cancer. METHODS: A multicenter, open, non-randomized and crossover clinical trial on the effect of anastrozole was conducted. Sixty-one postmenopausal women with advanced breast cancer were treated by oral anastrozole, 1 mg once every day. Each patient received 4-6 weeks of treatment. Plasma estradiol concentrations were determined 2 weeks before treatment and within 3 days after treatment discontinued. Effect and adverse reaction were evaluated. RESULTS: The response rate in 60 evaluable cases treated with anastrozole was 21.7% (CR = 0, PR = 13, MR = 2). The effect was correlated with postmenopausal time, previous endocrine therapy and ER status. Plasma level of estradiol was suppressed by 58.3%. The main adverse reactions, including nausea, fatigue, facial flush, were generally tolerable. CONCLUSION: As an aromatase inhibitor capable of decreasing plasma estradiol level, anastrozole is therapeutically effective for advanced breast cancer in postmenopausal women. Side effects are mild and tolerable.

Adult↗

PubMed1992

Allergen-induced increase in airway responsiveness is not inhibited by acute treatment with ketotifen or clemastine.

Allergen-induced increase in airway responsiveness to histamine or methacholine provides a useful model for investigation of prophylactic or "antiinflammatory" asthma treatments. This can be inhibited by corticosteroids or by sodium cromoglycate but not by beta agonists or by theophylline. A single-blind, crossover, random-order trial was conducted to compare ketotifen, clemastine, and placebo in six atopic subjects undergoing allergen inhalation tests. Ketotifen, 2 mg; clemastine, 1 mg; and placebo one tablet were administered twice daily for four days (eight doses) up to and including one hour before allergen inhalation. None of the three produced a significant reduction in the allergen-induced early or late asthmatic responses, or in the allergen-induced fall in methacholine PC20. There was a subtle nonsignificant suggestion of a reduction in the early portion of the early asthmatic response induced by both ketotifen and clemastine. Both ketotifen and clemastine produced a similar 8-fold inhibition of histamine skin test endpoint indicating equal systemic H1 blocking effect at the time of allergen inhalation. Sodium cromoglycate, 10 mg, single dose, by metered dose inhaler ten minutes before allergen challenge, added as an unblinded "positive control", inhibitory effects on the allergen-induced late and presumed inflammatory sequelae. It is possible that longer treatment periods (several weeks or months) might prove effective.

Adult↗

PubMedDate not supplied

Effects of pork vs veal consumption on serum lipids in healthy subjects.

AIMS: To analyse the influence of lean pork (P) and veal (V) consumption on the lipid profile of healthy subjects within the framework of a healthy diet comprising low levels of total fat (TF), saturated fatty acids (SFA) and cholesterol. DESIGN: Double-crossover, randomized and controlled trial SUBJECTS: 44 healthy individuals (22 male and 22 female), recruited voluntarily from the University Complutense of Madrid. The weight and lipid profiles of these volunteers were normal and their dietary patterns were typical for people in our area. INTERVENTIONS: The study comprised 4 phases: stabilisation phase (5 weeks), the participants followed their normal diet; second phase (6 weeks), half of the subjects, were randomised to lean pork or veal consumption, 150 g per day, for their main meal of the day; washout period (5 weeks) and final phase, which was the second phase of intervention (6 weeks). During the intervention stages, only the main meal of the day was taken in the Hospital. The rest of the subjects' diets consisted of different fortnightly menus designed in accordance with the recommendations of the Spanish Society of Arteriosclerosis (SEA). RESULTS: After both stages of intervention had been completed, there was a mean reduction of 5.5% in low-density lipoprotein cholesterol. However, after each intervention there were no significant differences between those who had consumed P, 2.62 (0.55) mmol/L and those who had consumed V, 2.71 (0.47) mmol/L. No differences were observed in any of the other parameters between those who had consumed P and those who had consumed V. CONCLUSIONS: Lean pork and veal produces similar effects on the lipid profiles of healthy subjects. Its consumption, as part of the saturated fat and cholesterol-controlled diet, could therefore be included in food guidelines, both for normal and therapeutic diets.

Adult↗

PubMed1991

Short-term dietary sodium restriction increases serum lipids and insulin in salt-sensitive and salt-resistant normotensive adults.

Evidence suggests that dietary salt reduction similar to diuretic therapy may adversely affect lipid and glucose metabolism. We studied 147 non-obese normotensive subjects (60 females and 87 males) aged 19-78 years who entered a single-blind crossover trial and were randomly assigned to a low salt diet of 20 mmol or a high salt diet of 300 mmol sodium per day, for 7 days each. Sodium restriction lowered mean arterial blood pressure (MAP) by a mean of 7.5 mmHg in 17% (salt-sensitive), had no hemodynamic effect in 67% (salt-resistant) and raised MAP by a mean of 6 mmHg in 16% of the subjects (reverse reactors). With dietary salt restriction serum total- and LDL-cholesterol as well as serum insulin and uric acid concentrations increased significantly in all three groups. The largest increases in total (10%) and LDL- (12%) cholesterol occurred in the reverse reactors. Salt-sensitives had significant higher lipoprotein(a) values than the other two groups. Salt-restriction had no significant effect on this parameter. Plasma renin activity, as well as plasma aldosterone and noradrenaline concentrations rose in all three groups during the low salt diet, the largest increases being observed in the reverse reactors. Short-term sodium restriction in normotensive adults has unfavourable effects on lipid and glucose metabolism, especially in subjects who do not derive hemodynamic benefit. Further studies are necessary to examine the effects of more moderate salt reduction for longer periods on the risk factor profile for cardiovascular disease before a low salt diet can be regarded as a safe public health measure for the general population.

Adult↗

PubMed2005

Intranasal lysine-aspirin in aspirin-sensitive nasal polyposis: a controlled trial.

OBJECTIVES/HYPOTHESIS: Intranasal lysine-aspirin has been used as a method of desensitization in patients with aspirin-sensitive nasal polyps to control their recurrence and prevent frequent surgical intervention. However, the studies are limited in number, and their design is open to criticisms. Thus, we conducted a controlled trial to study the clinical effectiveness of topical lysine-aspirin in patients with aspirin-sensitive nasal polyposis. STUDY DESIGN: Prospective, randomized, double blind, placebo controlled, crossover trial. METHODS: Aspirin-sensitive patients confirmed by intranasal challenge were enrolled and randomized to receive 16 mg of topical lysine-aspirin every 48 hours or placebo for 6 months before crossover. Polyp growth and nasal and chest symptoms were monitored using acoustic rhinometry, nasal inspiratory peak flow, peak expiratory flow rate, and a daily diary of symptom scores. RESULTS: Twenty-two patients were enrolled. After withdrawals and drop outs, data were available on 11 patients for analysis. Multivariate analysis of measured parameters did not reveal a significant clinical benefit to patients receiving topical lysine-aspirin compared with placebo. Deterioration was similar while on lysine-aspirin or placebo. CONCLUSIONS: This is the first controlled clinical trial of topical desensitization in aspirin-sensitive nasal polyp patients. Despite the failure to demonstrate clinical benefit, tissue studies have shown a significant improvement at the microscopic level. Further work with larger numbers of patients along with conventional treatment may show a clinical improvement in these patients.

Administration, Intranasal↗

PubMed1989

The effect of nitroglycerin ointment on exercise-induced angina: a multicenter trial.

The efficacy of nitroglycerin ointment was determined by treadmill exercise testing through a randomized, double-blind crossover trial with placebo in 22 patients with chronic stable exertional angina. On different days, 3 cm of nitroglycerin ointment (NGO, 18 mg) and placebo ointment were applied over the epigastric region, followed by the exercise test 1 hour later. The maximal exercise time was 459 +/- 124 seconds after application of placebo and 510 +/- 113 seconds after application of NGO, and the exercise time to 1 mm of ST-segment depression was significantly extended to 297 +/- 110 seconds after placebo and 366 +/- 134 seconds after NGO (p less than 0.01, p less than 0.001, respectively). ST-segment depression at the endpoint of exercise was significantly reduced from 2.4 +/- 1.2 mm to 1.5 +/- 0.7 mm after application of NGO (p less than 0.01). There was no difference in rate-pressure product at the endpoint of exercise between placebo and NGO. Adverse reactions were elicited in 5 of 22 patients. The results of this present study suggest that NGO is effective in the treatment of exertional angina.

Aged↗

PubMed2002

Transcutaneous electrical stimulation of an auricular acupuncture point decreases anesthetic requirement.

BACKGROUND: German anesthesiologists have long used transcutaneous electrical stimulation of an acupuncture point near the tragus to reduce anesthetic requirement in unblinded and uncontrolled trials. This is known as auricular electrically stimulated analgesia. The authors therefore tested the hypothesis that auricular electrically stimulated analgesia reduces anesthetic requirement. METHODS: In a randomized, double-blind, crossover trial, volunteers were anesthetized twice with desflurane. Electrical stimulation of an auricular acupuncture point in the vicinity of the tragus was used on 1 randomly assigned day, and no electrical stimulation of the same point was used on the other study day. Treatment consisted of bilateral electrical stimulation of the lateralization control point, 3 cm anterior to the tragus. The 10-mA current was set to 299 Hz on the dominant side of the face and to 149 Hz on the contralateral side. Anesthetic requirement was determined by the Dixon up-and-down method and was defined by the average desflurane concentration required to prevent purposeful movement of the extremities in response to noxious electrical stimulation. RESULTS: Ten men and 10 women completed the protocol. Electrical stimulation of the lateralization control point reduced anesthetic requirement by 11 +/- 7% (P < 0.001), with the reduction being similar in women and men. Women required more desflurane to prevent movement on the control day than the men (5.5 +/- 1.0 vs. 4.6 +/- 0.6 vol%; P = 0.028). CONCLUSION: This double-blinded trial with an objective outcome demonstrates that electrical stimulation of the lateralization control point significantly reduces anesthetic requirement.

Acupuncture Points↗

PubMed2005

A systematic review of telemedicine interventions to support blood glucose self-monitoring in diabetes.

AIMS: To evaluate evidence for feasibility, acceptability and cost-effectiveness of diabetes telemedicine applications. METHODS: MEDLINE, EMBASE, PSYCHINFO, CINAHL, Cochrane, and INSPEC were searched using the terms diabetes and telemedicine for clinical studies using electronic transfer of blood glucose results in people with diabetes. The technology used, trial design and clinical outcome measures used were extracted for trials and prospective cohort studies. Randomized controlled trials with HbA(1c) as an outcome were pooled using standard meta-analytical methods. RESULTS: We identified 539 papers among which 32 papers described 10 prospective cohort studies, 12 parallel group randomized controlled trials (RCT), three crossover trials, and one non-parallel group trial. Only two studies described full details of randomization, blinding of outcomes and dropouts and withdrawals. Electronic transfer of glucose results appears feasible in a clinical setting. Only two of the RCTs included more than 100 patients, and only three extended to 1 year. Only one study was designed to show that telemedicine interventions might replace clinic interventions without deterioration in HbA(1c). Results pooled from the nine RCTs with reported data did not provide evidence that the interventions were effective in reducing HbA(1c) (-0.1%, 95% CI -0.4% to 0.04%). CONCLUSIONS: Telemedicine solutions for diabetes care are feasible and acceptable, but evidence for their effectiveness in improving HbA(1c) or reducing costs while maintaining HbA(1c) levels, or improving other aspects of diabetes management is not strong. Further research should seek to understand how telemedicine might enhance educational and self-management interventions and RCTs are required to examine cost-effectiveness.

Blood Glucose Self-Monitoring↗

PubMed2005

Beta-cell response during a meal test: a comparative study of incremental doses of repaglinide in type 2 diabetic patients.

OBJECTIVE: To assess the effects of incremental doses of repaglinide on postprandial insulin and glucose profiles after a standard 500-kcal test meal. RESEARCH DESIGN AND METHODS: Sixteen diet-treated Caucasians with type 2 diabetes (mean HbA(1c) 8.4%) were enrolled in this randomized, open-label, crossover trial. Subjects received 0.5, 1, 2, and 4 mg repaglinide or placebo in a random fashion, followed by a standard 500-kcal test meal on 5 separate study days, 1 week apart. RESULTS: The insulinogenic index (DeltaI30/DeltaG30) and insulin area under the curve (AUC) from 0 to 30 min (AUC(0-30)) were higher with the 4-mg drug dose compared with the two lower doses and with 2 mg compared with 0.5 mg. On subgroup analysis, the incremental insulin responses were apparent only in the fasting plasma glucose (FPG) < 9-mmol/l subgroup of subjects and not in the FPG >9-mmol/l subgroup. There was a significant dose-related increase in the late postprandial insulin secretion (insulin AUC(120-240)), which resulted in hypoglycemia in four subjects. Proinsulin-to-insulin ratios at 30 and 60 min improved with increasing doses of repaglinide; higher drug doses (2 and 4 mg) were more effective than the 0.5- and 1-mg doses. CONCLUSIONS: Significant dose-related increases in early insulin secretion were found only in less advanced diabetic subjects. In advanced diabetic patients, only the maximum dose (4 mg) was significant compared with placebo. Better proinsulin-to-insulin processing was noted with increasing drug doses.

Adult↗

PubMed1998

Loratadine-pseudoephedrine in children with allergic rhinitis, a controlled double-blind trial.

AIMS: To conduct a randomized placebo controlled double-blind crossover trial in order to evaluate a loratadine-pseudoephedrine combination (L + PS) in children with seasonal allergic rhinitis. METHODS: Forty children (15 males; 25 females), aged 3-15 years, were included in this study. They were randomized to receive L + PS (0.2 mg kg[-1] body weight-2.4 mg kg[-1] body weight respectively) or placebo (PLA) for 14 days. After 7 days of washout, patients were shifted to the other treatment for a further 14 days. Nasal symptoms (sneezing/itching, congestion, nasal dripping) and signs (turbinal swelling, retronasal drainage), rated on a scale ranging from: 1. absent to 5. very intense, and their sum or mean total symptom score (MTSS) were used as efficacy measurement. RESULTS: Significant relief was observed; post-treatment MTSS difference and its percent change were respectively; L + PS = -4.29; 95% CI: -3.64 and -4.94 (27.8%), and PLA = -1.63; 95% CI: -0.95 and -2.31 (10.7%) (P < 0.001 baseline vs endpoint and between treatments). Furthermore, L + PS and PLA significantly modified symptoms, but only L + PS significantly modified signs. No clinical changes were observed during the trial; only one patient showed slight transient insomnia when receiving L + PS. CONCLUSIONS: It is concluded that L + PS is useful and well tolerated in children with seasonal allergic rhinitis. However, elements such as placebo effect must be taken into account for planning future trials.

Adolescent↗

PubMed2005

A randomized, double-blind, double-dummy, safety crossover trial comparing cumulative doses up to 96 microg of formoterol delivered via an HFA-134a-propelled pMDI vs. same cumulative doses of formoterol DPI and placebo in asthmatic patients.

BACKGROUND: Formoterol's effects on the cardiovascular system are well known, but whether these effects are altered by the reformulation of inhalers to replace CFC propellants with HFA propellants is not. OBJECTIVES: To evaluate the effect of cumulative doses up to 96 microg of formoterol delivered via an HFA-134a-propelled pMDI, on cardiac safety and the QTc interval, compared the same cumulative doses delivered via a DPI, in adult patients with moderate-to-severe asthma. METHODS: This study was a multicenter, double-blind, double-dummy, placebo-controlled, three-period, crossover trial in which 22 patients with moderate-to-severe asthma received cumulative doses up to 96 microg of formoterol (12 + 12 + 24 + 48 microg) delivered via a pMDI or a dry power inhaler (DPI). Vital signs and fourteen 12-lead ECG measurements were taken at each clinic visit and at 5-10 days after the final drug administration. RESULTS: An increase from baseline in QTc interval was observed with all formoterol treatment arms in a dose-dependent manner. The maximum increases were 56.3, 62.6 and 25.0 ms for the formoterol pMDI, formoterol DPI and placebo treatments, respectively. Heart rate was increased by 10.7, 14.9 and 6.5 bpm in the pMDI, DPI and placebo groups, respectively. Both formoterol treatments were also associated with a decrease in diastolic blood pressure compared with placebo. CONCLUSIONS: With respect to cardiovascular safety parameters, the administration of formoterol via a pMDI device is comparable to its delivery via a DPI.

Adult↗