Effect of systemic corticoid and antihistamine alone or in combination on elements of the response to a two dose nasal allergen challenge.

This study examined the effects of low dose systemic corticoid (methylprednisolone, MP), standard dose antihistamine (terfenadine, TF) or the combination on response to out-of-season acute allergen challenge. We feel that a single dose challenge delivered to the nose may represent real disease imperfectly and in this study used two doses given 1 hour apart, hoping to approximate better the circumstances of natural allergen stimulation. The study used clinical endpoints only: measured nasal airway resistance (NAR), sneeze count, and weight of blown nasal secretions.

Dose-Related Hepatic Blood Flow Effects Differentiate Nicorandil, Hydralazine, and Isosorbide Dinitrate in Healthy Subjects.

Dose response on hepatic blood flow of nicorandil (2.5, 5, and 10 mg), isosorbide dinitrate (5, 15, and 40 mg), and hydralazine (10, 25, and 50 mg) was assessed in 18 healthy subjects (6 per drug) using a three-period crossover design. Indocyanine green clearance was used to estimate hepatic blood flow before and at two timepoints after dosing.

Lack of effects of beta-carotene on lipids and sex steroid hormones in hyperlipidemics.

Beta-carotene in doses of up to 300 mg daily raises high-density lipoprotein cholesterol levels within 2 to 4 weeks in healthy subjects. The authors, in this study, investigate the short-term effects of high-dose beta-carotene upon serum lipids, lipoproteins, and selected sex steroid hormones in 59 adult patients with Type IIa or IIb hyperlipidemia and 36 healthy subjects. Volunteers took beta-carotene (300 mg) or wheat germ oil capsules daily for 30 days.

Acute effects of increasing doses of nicorandil on renal function in man.

The effects of nicorandil, a nicotinamide derived vasodilator combining nitrate and potassium channel opener actions, on kidney function have not been determined. This study investigated changes in renal blood flow and glomerular filtration rate as estimated using simultaneous 131I-iodohippurate and 125I-iothalamate plasma clearances. Forty-two healthy subjects in sodium balance received placebo and 2.

Phlebotomy of 500 or 750 milliliters of whole blood followed by isovolemic hemodilution or autologous transfusion yields similar hemodynamic, hematologic, and biochemical effects.

The purpose of this study was to evaluate the effects of phlebotomy of 500 or 750 ml of whole blood followed by isovolemic hemodilution or autologous transfusion on hemodynamic, hematologic, and biochemical parameters in healthy subjects. Four groups of normovolemic male subjects (n = 6 or 7 per group), aged 18 to 41 years, participated in this 10-day study at Upjohn Research Clinics, Kalamazoo, Mich. On day 1 two groups had phlebotomy of 500 ml; of these, one group underwent immediate postphlebotomy autologous transfusion (group 1) and the other underwent immediate postphlebotomy isovolemic hemodilution and then autologous transfusion on day 3 (group 2).

Effect of vasoconstrictor pre-treatment on obstruction, secretion and sneezing after nasal challenge with threshold and suprathreshold allergen doses.

Acute nasal allergen challenge produces airway obstruction which varies in amount and timing with the allergen dose delivered. To see whether different mechanisms might contribute variably to mucosal swelling with different amounts of allergen, we challenged sensitive volunteers with threshold and 10-times threshold allergen doses, with and without topical vasoconstrictor pre-treatment. The vasoconstrictor effectively eliminated obstruction at both allergen dose levels, suggesting that acute vascular changes were responsible for all the measurable obstruction seen with acute allergen provocation.

Oral methylprednisolone acetate (Medrol Tablets) for seasonal rhinitis: examination of dose and symptom response.

The authors compared the effect of several doses an oral corticosteroid on symptom profile and severity in ragweed hay fever. Thirty-one patients were randomized to receive 0, 6, 12, or 24 mg methylprednisolone (Medrol Tablets [MP], Upjohn, Kalamazoo, MI). A baseline week in which no treatment was given preceded the treatment comparison.

Continuous intravenous dosing with ciprostene using a portable pump in ambulatory patients.

Parenteral compounds present special drug delivery challenges. This open-label study evaluated a portable infusion pump as a means to deliver intravenous ciprostene, a stable prostacyclin analog. Ten patients with peripheral vascular disease and claudication received ciprostene (titrated to 120 ng/kg/min) infused over 8 hours 1 day per week for 4 consecutive weeks.

A double stopcock technique for repeated sampling of venous blood.

Repeated sampling for measurement of venous blood levels of hemoglobin, hematocrit, plasma hemoglobin, potassium and ibuprofen with a novel method of phlebotomy, the double stopcock technique (DST), was compared to heparin lock (HPL), Angiocath with obturator (AOB) and direct venipuncture (DVP) techniques. There were 12 normal subjects in this randomized, three-way crossover trial. During each portion of the crossover, simultaneous samples for hemoglobin, hematocrit, plasma hemoglobin, potassium and ibuprofen were taken from each phlebotomy site prior to and after oral dosing with 400 mg ibuprofen.

Synergistic effects of oral nonsteroidal drugs and topical corticosteroids in the therapy of sunburn in humans.

The ability to modify skin injury due to ultraviolet light (UVB) by the nonsteroidal anti-inflammatory drugs (NSAIDs) oral ibuprofen (IB) or indomethacin (IN) plus topical betamethasone dipropionate (BD) was studied in 24 subjects in this open-label, four-way, cross-over trial. All subjects received UVB at weekly intervals: group 1 was randomized to IB, BD, IB + BD or control, and group 2 to IN, BD, IN + BD or control. Oral medications were given prior to and after exposure to UVB, but BD was applied only afterwards.

Unilaterality of obstruction after acute nasal allergen provocation. Relation of allergen dose, nasal reactivity and the nasal cycle.

We examined unilaterality of obstruction after acute bilateral nasal allergen provocation in two groups of pollen-sensitive volunteers studied out of season. One group was challenged on one occasion with a threshold allergen dose and on another with placebo. We measured nasal airway resistance (NAR) unilaterally for 3.

Beta-carotene's effects on serum lipoproteins and immunologic indices in humans.

Doses of beta-carotene for cancer-prevention trials have been chosen based on epidemiologic data. Mechanisms of the putative antineoplastic effects by beta-carotene are unknown but may involve modulation of the immune system. We measured plasma carotenoid concentrations and selected immunologic indices at baseline and at 2 and 4 wk in 50 healthy humans (5 groups of 10 each) ingesting 0, 15, 45, 180, or 300 mg beta-carotene/d for 1 mo in this randomized placebo-controlled, open-label, parallel study.

Fish oil produces an atherogenic lipid profile in hypertensive men.

The effects of fish oil supplements on plasma and platelet membrane lipids, lipoproteins, sex steroid hormones, glucose, insulin, platelet aggregation, and blood pressure in normal subjects (n = 13) and patients with essential hypertension (n = 13) were studied in this randomized, double-blind, placebo-controlled, two-way crossover study. Treatments consisted of 30 days of 5 g of n-3 fatty acids (ten 1-g capsules of fish oil daily) or placebo capsules (ten wheat germ oil capsules daily) with a one-month washout in between each crossover. Serum lipids and lipoproteins were measured before dosing and every two weeks during the study.

New methods to detect the effect of alteration in gastric pH and intestinal transit by metoclopramide and propantheline using a continuous gastric pH probe and hydrogen breath analysis.

Unlabelled: The effects of oral doses of metoclopramide (M, 10 mg) and propantheline (P, 30 mg) on alteration in gastric pH and emptying were determined using a continuous pH probe (Digitrapper, Synectics) and hydrogen breath analysis (HBA, QuinTron) in eight male subjects. The four phases consisted of HBA, HBA and pH probe, and HBA and pH probe and either P or M. Baseline pH measurements were recorded for 60 min prior to dosing with 10 g of lactulose in three of the periods.

The effect of ketoconazole and transdermal estradiol on serum sex steroid hormones levels.

In this randomized, open-label trial, 24 subjects were studied. There were 12 subjects with essential hypertension and 12 normotensive controls who received, after an initial control period, 48 h of treatment with a transdermal estradiol patch or ketoconazole tablets every 8 h for six doses, or in combination. LHRH (100 micrograms) and ACTH (250 micrograms) were given at 48 h of each treatment.

Profile of ragweed hay fever symptom control with terfenadine started before or after symptoms are established.

Forty-two ragweed hay fever patients participated in a study which examined the profile of symptom relief provided by terfenadine, and the relative adequacy of symptom control with the drug given from the beginning of the season compared with treatment started after symptoms were well established. Compared with placebo, terfenadine effectively relieved sneeze, itch and eye symptoms. It had no effect on running, blowing and drainage.

The effects of gastric pH and food on the pharmacokinetics of a new oral cephalosporin, cefpodoxime proxetil.

The effects of alteration of gastric pH and food on the pharmacokinetics of 200 mg doses of cefpodoxime proxetil tablets were studied in two separate randomized, open label, crossover studies in healthy subjects. In the pH study (n = 17 subjects), there was a lead-in period done under fasting conditions, followed by randomization to a four-way crossover of pentagastrin (6 micrograms/kg, subcutaneously), ranitidine (150 mg orally, 10 and 2 hours before dosing with the antibiotic), sodium bicarbonate (12.6 gm), or aluminum hydroxide (120 cc).

The effects of cefmetazole and latamoxef on platelet function in healthy human volunteers.

This study has compared the effects of normal saline (placebo), cefmetazole, and latamoxef (moxalactam) on platelet function in healthy human volunteers. Twenty-nine volunteers were randomized to receive placebo (n = 10), cefmetazole 2 g (n = 9) or latamoxef 2 g (n = 10) intravenously every 6 h for six days. Under double-blind conditions template bleeding time and ex-vivo adenosine diphosphate (ADP) induced platelet aggregation were measured before drug dosing, after the first, ninth, and last drug doses and one and three days after the last drug dose.