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Results for “randomized crossover trial”

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PubMed1986

[Budesonide (Pulmicort) and exertion-induced asthma].

Twelve young adult asthmatic patients were selected in an asthma-free interval to be tested for exercise-induced bronchoconstriction. The degree of bronchoconstriction was estimated indirectly by spirometry, using FEV1 as parameter. Exercise was performed on a 10% steep treadmill for six minutes, leading to a pulse rate of more than 180 beats/min. Spirometry was done before, immediately after, and 10 and 20 min after the work. Only patients with more than a 10% fall in FEV1 during the 20 min period of recovery were selected. In the randomized crossover double blind trial the asthmatic patients received placebo inhalations for one week and budesonide inhalations for another week (2 X 800 micrograms daily). Spirometry was repeated at the end of each week. Under placebo we found a surprisingly high rate of protection against exercise-induced bronchoconstriction (50%, p less than 0.05). With budesonide 8% additional protection (compared to placebo) was achieved (mean of all 12 patients). The patient-drug-interaction was significant at the level of F = 30, p less than 0.05. There are some nonresponders to budesonide. Of the 12 asthmatics, 8 recognized the drug inhalation period. We conclude that one week of high dosage budesonide regimen recudes the tendency to exercise-induced asthma in adults. Budesonide seems to influence and mitigate bronchial hyperreactivity in the responder group.

Adolescent↗

PubMed2006

Pharmacokinetic evaluation and safety profile of a 15-minute versus 30-second infusion of palonosetron in healthy subjects.

Palonosetron is a potent, selective 5-HT(3) receptor antagonist effective in the prevention of acute and delayed chemotherapy-induced nausea and vomiting. In practice, 5-HT(3) receptor antagonists, including palonosetron, are often coadministered with dexamethasone over approximately 15 minutes, although the approval of palonosetron was based on administration as a 30-second infusion. This open-label, randomized, 2-way crossover trial compared the pharmacokinetics and safety of palonosetron 0.25 mg administered as a 15-minute 50-mL intravenous infusion with a 30-second 5-mL infusion. Aside from an anticipated 40% decrease in maximum plasma concentration after a 15-minute infusion, the pharmacokinetics of palonosetron (including area under the plasma concentration-time curve [AUC], plasma elimination half-life, total body clearance, and apparent volume of distribution at steady state) were similar for both treatments. Both treatments were well tolerated, with no significant changes in vital signs or electrocardiograms. Palonosetron infused over 15 minutes is well tolerated, with an AUC(0-infinity) equivalent to a 30-second infusion.

Adolescent↗

PubMed2004

[Effect of montelukast on lung function and clinical symptoms in patients with cystic fibrosis].

Inflammatory process contributes to progressive lung tissue damage in cystic fibrosis (CF). Cysteinyl leukotrienes have been found in the sputum of CF patients at concentrations sufficient to cause potent biological effect. This study was designed to assess the effect of anti-inflammatory treatment with montelukast sodium in CF patients. Twelve patients, aged 6-29 were recruited. It was 20 week, placebo-controlled, and randomized, double blind, crossover trial. At first and last week of each treatment course spirometry and whole body plethysmography parameters (FEV1, PEF, FEF25/75%, VC, TGV, Raw and RV) and clinical wheezing and cough scale were measured. In montelukast group significant improvement in FEV1 (mean +/- SD, 54.6 +/- 22.6 before and 62 +/- 19.0 after treatment, p=0.0112) and FEF25/75% (28.9 +/- 23.0 before and 37.5 +/- 25.5 after treatment, p=0.0053) were observed. Compared with placebo montelukast significantly improved FEV1 (p=0.0032), PEF (p=0.0298) and FEF25/75% (p=0.0091). There was no significant difference in VC, TGV, Raw and RV. Montelukast compared with placebo significantly decreased cough (p<0.0001) and wheezing (p=0.0002) score. In summary, therapy with montelukast may provide clinical benefit to patients with CF.

Acetates↗

PubMed1987

Comparative effects of intravenously administered alizapride and prochlorperazine in cisplatin-induced emesis.

A randomized, double blind crossover trial compared the antiemetic effects of alizapride, a benzamide, and prochlorperazine, a phenothiazine, both administered intravenously to 32 patients treated with chemotherapy combinations containing cisplatin. The total dose of alizapride administered to each patient was 14 mg/kg, and of prochlorperazine .56 mg/kg, divided in five doses. Although alizapride resulted in complete protection against emesis in 31% of the patients during their first course of cisplatin therapy, 42% of those who received alizapride had five or more episodes of emesis. Although prochlorperazine was less effective in offering complete protection against emesis, only 15% of the patients receiving this drug vomited more than five times. The duration of emesis during prochlorperazine treatment was also significantly shorter than during alizapride therapy (p less than 0.02). Optimal dosage and pharmacokinetic distribution of both drugs should be investigated further.

Adult↗

PubMed1996

Randomized, double blind comparison of brand and generic antibiotic suspensions: II. A study of taste and compliance in children.

BACKGROUND: The taste of oral liquid medications influences compliance in children. Generic preparations are prescribed to reduce cost and may taste worse than brand name products. METHODS: This was a prospective, randomized, double blind, crossover trial of the differences in taste and compliance between brand and generic antibiotic suspensions in children 3 to 14 years of age. Verbal and visual assessment methods were used to assess taste, and compliance was measured by the amount of drug returned after use. RESULTS: Ten children in each of the cephalexin and erythromycin-sulfisoxazole groups did not report that the brand and generic formulations tasted differently. Fifteen children thought that brand trimethoprim-sulfamethoxazole tasted better than the generic preparation. CONCLUSIONS: Brand name oral liquid antibiotics do not necessarily taste better than their generic counterparts. Despite preference for the taste of brand trimethoprim-sulfamethoxazole, all of the children in this study were compliant with both brand and generic medications.

Adolescent↗

PubMedDate not supplied

Formoterol thrice weekly does not result in the development of tolerance to bronchoprotection.

BACKGROUND: Loss of bronchoprotection routinely follows regular treatment with beta2-agonists. There are no data on the effects on bronchoprotection for thrice weekly use of a beta2-agonist. METHODS: A double-blind, randomized, placebo controlled crossover trial was conducted to investigate the effects of thrice weekly administration of 12 microg of formoterol versus placebo on bronchoprotection against methacholine. As an expected positive control, formoterol 12 microg once daily was also evaluated. RESULTS: There was no significant difference versus placebo in the bronchoprotective effects of 12 microg of formoterol administered on day 8, following daily treatment for seven days or treatment every other day (analysis of variance P=0.34). However, a nonsignificant trend towards lower concentration of methacholine that caused a 20% fall in forced expiratory volume in 1 s developed only following the daily formoterol dosing. CONCLUSIONS: Thrice weekly dosing does not result in the development of tolerance to bronchoprotection against the direct acting stimulus methacholine.

Administration, Oral↗

PubMed2006

Telemedical support to improve glycemic control in adolescents with type 1 diabetes mellitus.

INTRODUCTION: In this paper, we evaluated the feasibility of a telemedical (TM) support program and its effect on glycemic control in adolescents with type 1 diabetes mellitus (T1DM). Thirty-six adolescents (m=20, median age at the start of the study: 15.3 years (range: 10.7-19.3 years), median age at diagnosis: 9.3 years (2.1-13.8 years), median duration of disease: 6.4 years (1.0-12.8 years), HbA1c>8%, all on intensified insulin therapy) were randomized in a crossover trial over 6 months (3 months with TM, 3 months with conventional support and paper diary (PD)). During the TM phase, the patients sent their data (date, time, blood glucose, carbohydrate intake, insulin dosage) via mobile phone, at least daily, to our server and diabetologists sent back their advice via short message service (SMS) once a week. RESULTS: Glycemic control improved during the TM phase, while it deteriorated during the PD phase: TM-PD group HbA1c (%, median (range)): 9.05 (8-11.3) (at 0 months), 8.9 (6.9-11.3) (at 3 months), and 9.2 (7.4-12.6) (at 6 months), and PD-TM group: 8.9 (8.3-11.6), 9.9 (8.1-11), and 8.85 (7.3-11.7) (p<0.05). Patients rated the TM support program to be a good idea. Technical problems with General Packet Radio Service (GPRS) data transmission led to data loss and decreased patient satisfaction. CONCLUSION: Our telemedical support program, VIE-DIAB, proved to be feasible in adolescents and helped to improve glycemic control.

Adolescent↗

PubMed2004

Comparison of efficiency and preference of metal and plastic spacers in preschool children.

BACKGROUND: The metal NebuChamber valved holding chamber (VHC) has gained wide acceptance among children with asthma. Due to its nonelectrostatic properties and larger volume, the 250-mL, metal NebuChamber delivers a greater mass of aerosol to a filter at the mouth compared with the commonly used 150-mL polypropylene AeroChamber VHC. Such in vitro results have been used to suggest that this may provide increased efficacy with the NebuChamber. No comparative efficacy data exist for preschool children with asthma. OBJECTIVE: To compare efficiency and preference of metal and plastic spacers in preschool children. METHODS: Children with mild-to-moderate persistent asthma received 200 microg of budesonide twice daily by NebuChamber or AeroChamber, both with the mask provided in a randomized, 2-month, crossover trial. Symptom diary cards, beta-agonist use, and preference by children and parents were compared. RESULTS: Thirty children (mean +/- SD age, 4.3 +/- 0.3 years) completed the study. There was no difference between the AeroChamber and NebuChamber in clinical efficacy outcomes. There was no difference between the AeroChamber and NebuChamber in parents' view of ease of use, design, acceptability by the children, and overall satisfaction. CONCLUSIONS: Despite a greater total dose delivered to the mouth, the NebuChamber appears no more effective than the AeroChamber and it is not preferred by patients or parents. More parents chose to continue to use the NebuChamber after the study.

Administration, Inhalation↗

PubMed2003

Visual stimulation as pain relief for Hong Kong Chinese patients with leg ulcers.

Analgesic potential of visual stimulation was examined in 33 patients with leg ulcers in a randomized, controlled, crossover clinical trial. Patients were alternating between wearing an eyeglass display with soundless VCD broadcast (V-sessions) and a static blank screen (B-sessions) while receiving superficial debridement and wound dressing for their leg ulcers. A significant reduction in pain scores was found during V-sessions (VAS 67.7 +/- 28.4 vs. 25.6 +/- 29.8 when V-sessions vs. B-sessions, with p < 0.01). Age was positively correlated with the improvement in VAS, whereas gender, residency, and the underlying medical conditions were not correlated with the improvement in pain score. The use of visual stimulation might be beneficial to both genders, in an older age group regardless of the underlying medical conditions. This is the pioneer use of visual stimulation as a non-pharmacological adjuvant to pain relief among a local Chinese population. The study will certainly add knowledge to the existing pain relief methods.

Adult↗

PubMed1999

Increased proinflammatory cytokines in patients with chronic stable angina and their reduction by aspirin.

BACKGROUND: Proinflammatory cytokines released by injured endothelium facilitate interaction of endothelial cells with circulating leukocytes and thus may contribute to development and progression of atherosclerosis. We investigated whether cytokines and C-reactive protein (CRP) are indicative of myocardial ischemia or of diseased vessels and whether they are influenced by aspirin treatment in patients with chronic stable angina. METHODS AND RESULTS: Plasma macrophage colony stimulating factor (MCSF), IL-1b, IL-6, and CRP were measured in 60 stable patients after 48-hour Holter monitoring and in 24 matched controls. All patients had angiographic documentation of disease and positive exercise ECGs. Patients with ischemia on Holter monitoring (n=40) received aspirin or placebo in a 6-week, randomized, double blind, crossover trial. Blood sampling was repeated at the end of each treatment phase (3 weeks). Compared to controls, patients had more than twice median MCSF (800 versus 372 pg/mL), IL-6 (3.9 versus 1.7 pg/mL), and CRP (1.25 versus 0.23 mg/L) levels (P<0.01 for all comparisons). MCSF was related to ischemia on Holter monitoring (P<0.01), to low ischemic threshold during exercise (P<0.01), and together with IL-1b to number of diseased vessels (P<0.05). MCSF, IL-6, and CRP were all reduced after 6 weeks of aspirin treatment (P<0.05). CONCLUSIONS: These findings suggest that cytokines are associated with both ischemia and anatomic extent of disease in patients with stable angina. Reduced cytokine and CRP levels by aspirin may explain part of aspirin's therapeutic action.

Adult↗

PubMed2006

The effect of timolol-dorzolamide and timolol-pilocarpine combinations on ocular blood flow in patients with glaucoma.

PURPOSE: To investigate the effect of timolol-dorzolamide and timolol-pilocarpine fixed combinations on retrobulbar vessel blood flow. DESIGN: Prospective, randomized, masked, crossover clinical trial. METHODS: Sixteen patients with primary open angle glaucoma, treated with timolol 0.5%, received timolol 0.5%-dorzolamide 2% and timolol 0.5%-pilocarpine 2% for four weeks each. Heart rate, blood pressure, intraocular pressure (IOP), and peak systolic (PSV) and end diastolic velocities (EDV) in ophthalmic, central retinal, and short posterior ciliary arteries were measured before and after each treatment, and resistivity index was calculated. RESULTS: The IOP was reduced (P < .01) by timolol-dorzolamide and, more effectively, timolol-pilocarpine combinations. In central retinal artery, the end diastolic velocity was increased by the timolol-dorzolamide combination (P < .01), resulting in higher end diastolic velocity and lower resistivity index values (both P < .01) compared with the timolol-pilocarpine combination. CONCLUSIONS: The timolol-dorzolamide combination increases the end diastolic velocity in central retinal artery, despite a lower intraocular pressure decrease, suggesting an effect on retinal circulation.

Aged↗

PubMed1996

Ambulatory blood pressure on and off continuous positive airway pressure therapy for the sleep apnea/hypopnea syndrome: effects in "non-dippers".

Ambulatory blood pressure (BP) monitoring was performed in 13 patients with the sleep apnea/ hypopnea syndrome (SAHS) during a randomized, placebo controlled crossover trial of the effects of continuous positive airway pressure (CPAP) therapy. BP was monitored at half-hourly intervals for a 24-hour period both on CPAP and on an oral placebo, each given for a minimum of 3 weeks. Objective effective CPAP use averaged 4.3 hours per night. Weight and anti-hypertensive medications remained stable over the study period. Systolic, diastolic and mean arterial BP for 24-hour, daytime and nighttime periods were not significantly different on placebo compared to CPAP. Those patients with no significant overnight fall in BP on placebo ("non-dippers") showed a significant improvement in daytime mean arterial BP on CPAP (98 +/- 4 mm Hg) compared to placebo (102 +/- 4 mm Hg; p = 0.01). These findings, in a well-controlled trial, suggest that BP is not reduced by CPAP in a heterogeneous group of SAHS patients, but it may be selectively improved in those patients most at risk for cardiovascular morbidity and mortality.

Adult↗

PubMed2000

Comparison of the palatability of the oral suspension of cefdinir vs. amoxicillin/clavulanate potassium, cefprozil and azithromycin in pediatric patients.

BACKGROUND: Patient adherence to therapeutic regimens is extremely important to successful treatment of acute otitis media. Among pediatric patients medication palatability, particularly that of oral suspensions, is essential for patient acceptance, therapeutic compliance and successful outcome. METHODS: A series of six randomized, single blind, crossover trials were conducted, each comparing cefdinir oral suspension with one of the following antibiotic oral suspensions: amoxicillin/clavulanate potassium; cefprozil; or azithromycin. Each medication comparison was evaluated in a single center and multicenter study. Subjects 4 to 8 years of age were asked to taste and smell each medication and assign preference using a visual "smile-face" scale. Ratings were converted to a numeric score ranging from 5 ("really good") to 1 ("really bad"). RESULTS: Among the 715 subjects 85% rated the taste of cefdinir as good or really good, the highest possible ratings; 63% of subjects assigned the same ratings to amoxicillin/clavulanate potassium, cefprozil or azithromycin. Seventy-one percent rated the smell of cefdinir as good or really good; 64% assigned the same ratings to the comparators. CONCLUSIONS: Based on the findings from these trials, children 4 to 8 years of age preferred the taste and smell of cefdinir oral suspension to that of the comparator agents.

Administration, Oral↗

PubMed2006

Effects of electrostimulated acupuncture on ground reaction forces and pain scores in dogs with chronic elbow joint arthritis.

OBJECTIVE: To determine whether use of electrostimuluated acupuncture (ESA) would result in significant improvements in ground reaction forces and lameness scores in dogs with chronic elbow joint osteoarthritis secondary to elbow joint dysplasia. DESIGN: Randomized, controlled, crossover clinical trial. ANIMALS: 9 dogs with chronic forelimb lameness and radiographic evidence of elbow joint osteoarthritis. PROCEDURES: All dogs had a 3-week control acclimation period during which gait analysis was performed weekly. Dogs then received ESA once weekly for 3 weeks followed by a sham treatment once weekly for 3 weeks or received the sham treatment followed by ESA. Gait analysis was repeated prior to each treatment, and owners were asked to provide pain scores by use of a visual analog scale method. RESULTS: Treatment (control, acupuncture, or sham) did not have a significant effect on ground reaction forces for any limb. Owners of 8 of the 9 dogs were able to correctly guess the time period when ESA was delivered. CONCLUSIONS AND CLINICAL RELEVANCE: Results suggested that ESA did not have any significant effects on severity of lameness, as determined by measurement of ground reaction forces, or severity of pain, as determined by visual analog scale pain scores, in dogs with chronic elbow joint osteoarthritis secondary to elbow joint dysplasia.

Acupuncture Therapy↗

PubMedDate not supplied

Treatment of lactose intolerance with exogenous beta-D-galactosidase in pellet form.

The effectiveness of a new beta-D-galactosidase pellet formulation in the treatment of lactose intolerance was studied. The encapsuled beta-D-galactosidase (lactase) pellets were first tested in vitro for their enzymatic activity within an environment simulating gastric conditions and subsequently within an environment simulating duodenal conditions. Effectiveness was measured by the % of glucose formed by hydrolysis of lactose. The pellets were found to retain their enzymatic activity in gastric pH conditions (mean 69 +/- 1 mg/dl glucose) and were found to hydrolyse lactose in human duodenal fluid (106.35 +/- 1 mg/dl). Finally the effectiveness of the new lactase formulation on glucose absorption was studied in 8 lactose intolerant subjects in a randomized, double blind, crossover trial. After fasting, the subjects were given one capsule containing 100 u/ml beta-galactosidase (i.e. 10 pellets of 10 u/ml each) or one capsule containing placebo pellets, followed by 100 g lactose dissolved in water. The washout period between lactose challenges was one week. Plasma glucose concentrations were measured before and at intervals after the challenges and the subjects completed symptom questionnaires every eight hours for 24 hours. Results showed a statistically significant increase in plasma glucose levels 30, 60, 90 and 120 min after lactose ingestion (repeated measures analysis of variance, p<0.01). Subjective ratings of the severity of abdominal cramping, belching, flatulence, vomiting and diarrhoea were significantly decreased following ingestion of the lactase pellets and lactose (no incidence of diarrhoea) compared with after ingestion of placebo and lactose. The results of the study were considered to be very promising as the beta-D-galactosidase formulation (which was produced at very low cost and with great ease) resisted inactivation in the stomach, effectively transformed lactose to glucose in vivo and reduced symptoms of lactose intolerance.

Adult↗

PubMedDate not supplied

The functional response of infants with persistent wheezing to nebulized beclomethasone dipropionate.

Lung function was measured in nine infants, ages 15-36 weeks, who had persistent wheezing, apparently following acute bronchiolitis, before and after 2 weeks of treatment with either inhaled nebulized beclomethasone dipropionate (BDP) or placebo in a randomized, double blind, crossover trial. The effect of nebulized albuterol (Salbutamol) was measured before and after the steroid treatment. Thoracic gas volume (TGV) and specific airway conductance (SGaw) were determined using a whole body plethysmograph, and forced expiratory flow at resting lung volume (VmaxFRC) was determined with a thoracoabdominal compression jacket. All infants had marked airways obstruction before treatment with mean +/- SE VmaxFRC of 24 +/- 4% predicted and SGaw of 37 +/- 5% predicted. Two weeks of placebo treatment had no significant effect on lung function, but after 2 weeks of BDP inhalation there was a significant rise in SGaw to 61 +/- 7% (P less than 0.005). VmaxFRC increased to 42 +/- 13% but the difference did not reach significance. Respiratory rate and clinical score for retractions and wheezing also fell significantly with BDP therapy (P less than 0.01 and P less than 0.001 respectively). Albuterol had no effect on lung function either before or during steroid therapy. Steroids may have a role in the management of persistent wheezing following bronchiolitis.

Administration, Intranasal↗

PubMed2006

Relationship between response to methylphenidate treatment in children with ADHD and psychopathology in their families.

OBJECTIVE: To compare the pattern of familial aggregation of psychopathology in children who are good responders (GR) to methylphenidate (MPH) versus those who are poor responders (PR). METHOD: A total of 118 clinically referred children ages 6 to 12 years, diagnosed with ADHD participated in a double-blind, placebo-controlled, randomized 2-week crossover trial of MPH from 1999 to 2004. A low dose of 0.5 mg/kg of body weight of MPH divided in two equal doses was used. Family history was obtained by interviewing at least one key historian relative of each subject using Family Interview for Genetic Studies. Information was collected on 342 first-degree and 1,151 second-degree relatives of children with attention-deficit/hyperactivity disorder. RESULTS: Forty-four subjects showed mild or no improvement (PR) and 74 showed moderate or very much improvement (GR) on MPH over placebo. First-degree relatives of GR subjects were at significantly higher risk of attention-deficit/hyperactivity disorder than the relatives of PR subjects (p<.05). Second-degree relatives of the GR were at significantly higher risk of antisocial personality disorder compared to the relatives of PR subjects (p<.05). CONCLUSIONS: The significantly higher presence of attention-deficit/hyperactivity disorder in the first-degree relatives and of antisocial personality disorder in the second-degree relatives of GR children suggests that this group may, at least partially, be distinct from the PR group on the basis of genetic determinants.

Attention Deficit Disorder with Hyperactivity↗

PubMed2006

Energy-containing nutritional supplements can affect usual energy intake postsupplementation in institutionalized seniors with probable Alzheimer's disease.

OBJECTIVES: To determine whether increases in caloric intake associated with consumption of a mid-morning nutritional supplement for 3 weeks were maintained in the week after stopping the supplement and to investigate the effects of body mass index (BMI) and cognitive and behavioral measures on this response. DESIGN: Secondary analysis of a previously published randomized, crossover, nonblinded clinical trial. SETTING: A fully accredited geriatric care facility affiliated with the University of Toronto. PARTICIPANTS: Thirty institutionalized seniors with probable Alzheimer's disease (AD) who ate independently. MEASUREMENTS: Investigator-weighed food intake, body weight, cognitive (Severe Impairment Battery; Global Deterioration Scale) and behavioral (Neuropsychiatric Inventory--Nursing Home version; London Psychogeriatric Rating Scale) assessments. RESULTS: Individuals who responded successfully to supplementation as indicated by increases in daily energy intake were likely to maintain 58.8% of that increase postsupplementation, although stopping the supplement was associated with decreased habitual energy intake in low-BMI individuals who reduced their daily intakes during supplementation in response to the extra calories. Cognitive/behavioral tests were not reliable predictors of postsupplement intake. CONCLUSION: Institutionalized seniors with probable AD are likely to alter their usual energy intakes to maintain changes resulting from 3 weeks of supplementation. This effect may allow for rotating supplementation schedules in nursing homes that could reduce staff burden, but only for those individuals who are most likely to respond favorably. These data indicate that nutritional supplements and diet plans should be carefully prescribed in low-BMI individuals to limit variability in total energy provided and thus prevent lower-than-normal intake.

Aged↗