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Biomedical subjects

J H Day

Publications and source records attributed to J H Day.

At least 37 records · Page 2Linked to original sources
PubMed1997

Onset of action, efficacy, and safety of a single dose of fexofenadine hydrochloride for ragweed allergy using an environmental exposure unit.

BACKGROUND: Fexofenadine hydrochloride is the active acid metabolite of terfenadine. Fexofenadine's anti-allergic properties require confirmation in a clinical setting. OBJECTIVE: The purpose of this study was to characterize the time to onset of clinically important relief of symptoms of allergic rhinitis in subjects taking single doses of either 60 mg or 120 mg fexofenadine HCl, or placebo, after exposure to ragweed pollen in a controlled environment. Other objectives were to assess the efficacy and safety of single doses of fexofenadine HCl. METHODS: One hundred forty-six ragweed-sensitive subjects were primed in the off-season with ragweed pollen in the environmental exposure unit. One hundred thirty-six subjects who adequately responded to priming entered a single-dose placebo phase. Placebo-responders were disqualified from the study, leaving 99 subjects with adequate symptoms to be randomized and given a single dose of either fexofenadine HCl 120 mg (33), 60 mg (33) or placebo (33), after 60 minutes of allergen exposure. Exposure continued over five hours and subjects recorded symptoms every 20 minutes. This study was of a randomized, placebo-controlled, double-blind, parallel design. RESULTS: Median time to onset for relaxed criteria clinically important relief was 60 minutes for both fexofenadine treatment groups, and 100 minutes for placebo (P = .018). The proportion with relief was 82% at 60 mg, 85% at 120 mg, and 64% for placebo. Treated groups had reductions in symptom scores double that of placebo. CONCLUSIONS: Fexofenadine is safe and efficacious at single doses of 60 mg and 120 mg. Average time to onset was 60 minutes using controlled pollen exposure in an environmental exposure unit.

Adolescent↗
PubMed1997

Onset of action and efficacy of terfenadine, astemizole, cetirizine, and loratadine for the relief of symptoms of allergic rhinitis.

BACKGROUND: Terfenadine, astemizole, cetirizine, and loratadine are compared in their abilities to produce relief of symptoms of allergic rhinitis. OBJECTIVE: The aim of this study was to compare the onset of action and efficacy of the study medications. METHODS: 111 ragweed-sensitive subjects were primed with pollen in the Environmental Exposure Unit. Study entry required adequate symptoms over a 3 hour exposure to 5000 +/- 300 grains/m3 of ragweed pollen. On the test day, subjects were given a single dose of either terfenadine 60 mg (22), astemizole 10 mg (22), cetirizine 10 mg (23), loratadine 10 mg (22), or placebo (22) when sufficiently symptomatic after a 60-minute exposure. Allergen levels were maintained and symptoms recorded every 30 minutes. RESULTS: Proportions of subjects with clinically important relief were cetirizine, 69.6%; terfenadine, 54.5%; loratadine, 50.0%; astemizole, 40.9%; and placebo, 31.8% but differences weren't significant between treatment groups (P = .119). Survival curves for times to onset of clinically important relief for the four treatment groups were not different (P = .119). Subjects realizing definitive relief were cetirizine, 65.2%; terfenadine, 45.5%; loratadine, 31.8%; placebo, 27.3%; and astemizole, 22.7% (P = .023). Survival analysis of onset time for definitive relief found significant differences (P = .010). The ranking was cetirizine --> terfenadine --> loratadine --> astemizole (quickest to slowest). Global evaluation based on subject willingness to take the medication again yielded percentages: cetirizine, 82.6%; terfenadine, 66.7%; astemizole, 63.6%; loratadine, 40.9%; and placebo, 36.4% (P = .036). CONCLUSION: Cetirizine and terfenadine continuously ranked higher in terms of onset of action and efficacy, while loratadine and astemizole ranked lower. Significance was detected in definitive relief and relative efficacy.

Adolescent↗
PubMed1996

A randomized, double-blind, placebo-controlled, controlled antigen delivery study of the onset of action of aerosolized triamcinolone acetonide nasal spray in subjects with ragweed-induced allergic rhinitis.

BACKGROUND: Clinically apparent relief of nasal symptoms of allergic rhinitis is generally recognized to occur within 3 days to 1 week when intranasal corticosteroids are used. OBJECTIVE: A study was designed to evaluate the onset of action of triamcinolone acetonide (TA) in patients with ragweed-induced allergic rhinitis with an environmental exposure unit (EEU). METHODS: Eighty-five adults with ragweed-induced allergic rhinitis were primed with ragweed allergen in the EEU. Symptoms were recorded during a baseline exposure in the EEU, and subjects were randomized with a 5:1 ratio to receive either TA 400 micrograms (n = 71) or its propellant (n = 14). Subjects received study medication for 7 days under supervision in the morning and returned to the EEU in the evening for ragweed allergen challenge and symptom assessment. Clinically apparent onset of action was defined as a 25% decrease in symptom scores from baseline. RESULTS: A mean reduction in nasal congestion from baseline of greater than 25% (onset of action) was observed in the TA group, but not in the placebo group, by 10 hours. This was also observed for itching of the nose or palate and a combined measure of symptoms. In addition, the proportion of subjects with less nasal congestion after 1 day of treatment was greater in the TA group (41%) than in the placebo group (7%) (p less than 0.05). CONCLUSION: The unexpected early relief of symptoms observed in the TA group and, to a lesser extent in the placebo group, has important clinical implications in the treatment of allergic rhinitis.

Administration, Intranasal↗
PubMed1996

Intranasal fluticasone propionate versus loratadine in the treatment of adolescent patients with seasonal allergic rhinitis.

Fluticasone propionate (FP) is a topical corticosteroid with minimal systemic activity. We examined safety and compared the efficacy of FP aqueous nasal spray, 200 micrograms every day with loratadine tablets, 10 mg by mouth every day in 240 adolescents with ragweed pollen-induced seasonal allergic rhinitis for 4 weeks in a randomized, double-blind, parallel-group study. Nasal and eye symptoms were recorded daily on a 4-point (0 to 3) scale. A higher percentage of symptom-free days was observed for nasal blockage on waking during treatment with FP (p < 0.0001). Significant results were also obtained for all other nasal symptoms when analyzed for both symptom-free days and symptom scores. No differences were found for eye irritation symptoms (p = 0.14). Morning and evening nasal peak inspiratory flow (PIF) was recorded daily by 57 subjects. FP treatment was associated wit significantly higher PIF values than loratadine both morning (p = 0.0051) and evening (p = 0.0036). A greater improvement over 4 weeks was observed for PIF morning values in the FP group (p = 0.008) but not for evening values (p = 0.358). Statistically significant correlations were found for nasal blockage and PIF in the morning (r = -0.54, p = 0.0001) and in the evening (r = -0.46, p = 0.008).

Administration, Intranasal↗
PubMed1996

Efficacy of immunotherapy to ragweed antigen tested by controlled antigen exposure.

BACKGROUND: Immunotherapy is a recognized component in the management of allergic rhinitis. Its efficacy has been evaluated in a number of clinical field trials. These methods of evaluation are limited by control of antigen exposure. OBJECTIVE: A study was designed to evaluate the efficacy of immunotherapy in ragweed-induced rhinoconjunctivitis using an environmental exposure unit. METHODS: Forty-three subjects were grouped into (1) immunotherapy group: ragweed-allergic subjects on maintenance ragweed immunotherapy for at least 2 years (N = 16), (2) positive control group: ragweed-allergic subjects who had never received immunotherapy (n = 16), and (3) negative control group: ragweed-nonallergic subjects (N = 11). Ragweed specific skin tests and ragweed IgE levels were obtained prior to exposure. The study was done in a room where levels of 2,500 to 3,000 grains m3 of ragweed were maintained over three hours. Symptoms were recorded every 15 minutes. RESULTS: Nasal symptoms in the immunotherapy group were significantly less than in the positive control group after 45 minutes (P = .025). Significant differences were not observed for ocular symptoms. Combined nasal and ocular scores were 50% less in the immunotherapy group than in the positive control group by 75 minutes (P = .039). Ragweed-specific skin tests and IgE were significantly less in the immunotherapy group than in the positive control group. Rhinoconjunctivitis symptoms in the negative control group were absent throughout. CONCLUSIONS: Controlled ragweed pollen exposure in this setting demonstrated that ragweed immunotherapy significantly reduced symptoms of ragweed-allergic rhinitis but had no significant effect on ocular symptoms. This system presents opportunities for additional studies on immunotherapy for allergic respiratory conditions.

Adolescent↗
PubMed1994

Risk assessment in determining systemic reactivity to honeybee stings in sting-threatened individuals.

We evaluated the diagnostic parameters (sting rate, venom-specific RAST IgE, venom-specific RAST IgG, venom-specific IgG4, venom-specific skin test) of 224 individuals at risk of honeybee sting, assigned them a level of risk on the basis of a hypothetical risk model, and then sting challenged each subject with a live honeybee. Of the 70 subjects at the lowest risk level, only three (4.3%) experienced equivocal or mild systemic reactions, whereas eight (72.7%) of the 11 at the highest risk level experienced systemic reactions, of which five (45.5%) were severe. Increase in risk level was associated with an increased proportion of systemic reactions (p < 0.001). Of the individual diagnostic parameters, venom-specific RAST IgE was the best single predictor of reactivity (likelihood ratio = 0.759, p < 0.01). Venom-specific skin testing at a concentration of 0.1 microgram/ml was a better discriminator than a concentration of 1.0 microgram/ml but did not predict one severe systemic reaction. Three methods of prediction of risk and severity of reaction were examined; the one that assessed risk in the most clinically useful manner was similar to the hypothetical risk model. This model compared well with classical methods of risk assessment and may be used to assess high-risk individuals exposed to honeybees when management could include prophylactic immunotherapy.

Adolescent↗
PubMed1991

Bee venom anti-idiotypic antibody is associated with protection in beekeepers and bee sting-sensitive patients receiving immunotherapy against allergic reactions.

Bee venom (BV) anti-idiotypic (anti-Id) antibodies (Abs) were studied in nonreactive beekeepers, patients receiving BV immunotherapy (IT), and in patients with bee-sting hypersensitivity. Detection of serum anti-BV was determined either by the Phadebas RAST test for IgE and IgG concentrations or by isoelectric focusing followed by capillary blotting onto nitrocellulose membranes. Clonotypic analyses of Ab were made with specific probes for BV or BV anti-Id; 13/14 nonreactive multiple-sting beekeepers (93%; p = 0.00006) and 3/3 patients receiving BV IT (100%; p = 0.0026) had detectable amounts of BV anti-Id in serum, whereas five BV-sensitive patients (0%) and four ragweed-sensitive control patients (0%) did not. Beekeeper's serum containing BV anti-Id was found to recognize and bind to IgE anti-BV idiotype from two different patient sources and inhibit their reactions in a Phadebas RAST test in a dose-dependent manner. Nonreactive beekeepers generally had BV-specific IgE levels less than 0.35 PRU/ml in serum with detectable BV anti-Id. BV-allergic patients before IT had elevated BV-specific serum IgE levels, even in the presence of BV-specific IgG greater than 136 U/ml with no BV anti-Id present. These findings provide strong support for a protective role of BV anti-Id against bee sting--allergic reactions.

Adolescent↗
PubMed1990

Efficacy and safety of intranasal budesonide in the treatment of perennial rhinitis in adults and children.

The efficacy and safety of intranasal budesonide were evaluated in a placebo-controlled double-blind study of 51 children (6 to 18 years) and 48 adults with perennial (allergic or nonallergic) rhinitis. The trial commenced with a 2-week baseline period without treatment for perennial rhinitis. This was followed by a treatment period of 4 weeks. Treatment was either intranasal budesonide 200 micrograms bid or matching placebo bid. Nasal symptoms were rated daily on a scale from 0 (absent) to 3 (severe). Safety was monitored by laboratory assessments (hematology, blood chemistry, urinalysis) as well as by rhinoscopy and recording of adverse events. Budesonide reduced the nasal symptoms as compared with baseline. The reduction was greater than in the placebo group and symptoms were improved significantly on budesonide treatment compared with placebo. Laboratory assessments demonstrated no differences between budesonide and placebo. Adverse responses to intranasal budesonide were few and minor, and compliance was high. Intranasal budesonide, 200 micrograms bid, thus appears to be efficacious, highly acceptable, and safe for the treatment of perennial rhinitis.

Administration, Intranasal↗
PubMed1990

Physician reported patient response to immunotherapy: a retrospective study of factors affecting the response.

This study assessed physician evaluation of immunotherapy derived from questionnaires completed at specified intervals during the course of each program in 901 randomly selected patients in the Allergy Clinic, Kingston General Hospital, (1975 to 1985). The objective was to determine safety and efficacy and factors contributing to these from this information. Approximately ninety-six percent of completed questionnaires and 97.5% of patients reported symptomatic improvement. The requirement for supplemental medication was reported in 21.6% of questionnaires and by 35.6% of patients. This requirement was greater in females, in patients with asthma, and in patients with greater numbers of antigens administered. Single antigen programs provided the best response. Systemic reactions were reported in 6.7% of patients treated. In 1% of patients these reactions were severe and required adrenalin for management. Severe reactions occurred when higher concentrations of antigens were injected and frequently developed without warning of prior milder episodes. It was concluded that immunotherapy programs are safe and effective given in appropriate circumstances and with proper safeguards. A monitoring system, however, would provide valuable information on patient progress and collectively may indicate trends in response.

Female↗
PubMed1987

Immunologic studies of subjects with asthma exposed to formaldehyde and urea-formaldehyde foam insulation (UFFI) off products.

There has been concern in recent years as to the health hazards of exposure to potentially carcinogenic or immunotoxic substances in the environment. This study was done to determine the effects of exposure to urea-formaldehyde foam insulation (UFFI) off products on various hematologic and immunologic parameters in subjects with asthma: complete blood count and differential, erythrocyte sedimentation rate, lymphocyte subpopulations (E-rosetting, T3, T4, T8, B73.1, and Fc receptor positive lymphocytes and large granular lymphocytes), lymphocyte response to phytohemagglutinin and formalin-treated red blood cells (Form-RBC), serum antibody against the Thomsen-Friedenreich RBC antigen and against Form-RBC, and natural killer (NK), interferon (IFN)-boosted NK (IFN-NK), and antibody-dependent cell-mediated cytotoxicity. Four control subjects with asthma from conventionally insulated homes (control group) and 23 subjects with asthma from UFFI-insulated homes (home group) were exposed to placebo, formaldehyde, dust, and UFFI off gas at levels ordinarily found in UFFI-containing homes for four separate periods in an environmental chamber. Immunologic testing was carried out before the exposure series and 1 day after completion 7 days later as part of an investigation of respiratory and possible allergic effects of such exposure. Data from the UFFI-insulated home group were not significantly different from data of the normal conventionally insulated home control group for any of the variables studied, either before or after UFFI exposure. Paired t tests comparing data from each of the two groups before and after UFFI exposure demonstrated minimal but statistically significant increases in percent eosinophils and T8 positive cells in the UFFI-insulated home group only. Although NK, relative NK, and IFN-NK were normal in all groups, IFN-NK assays by use of a low concentration of alpha-interferon demonstrated a statistically significant decrease in NK response to IFN in both the control and UFFI-insulated home groups after UFFI exposure. These differences were not observed at optimum levels of IFN stimulation. These data indicate that long-term exposure to UFFI off products in the home apparently had no effect on the immunologic parameters studied. Short-term exposure resulted in minor immunologic changes in this subject population.

Antibody Formation↗
PubMed1984

Respiratory response to formaldehyde and off-gas of urea formaldehyde foam insulation.

In 18 subjects, 9 of whom had previously complained of various nonrespiratory adverse effects from the urea formaldehyde foam insulation (UFFI) in their homes, pulmonary function was assessed before and after exposure in a laboratory. On separate occasions formaldehyde, 1 part per million (ppm), and UFFI off-gas yielding a formaldehyde concentration of 1.2 ppm, were delivered to each subject in an environmental chamber for 90 minutes and a fume hood for 30 minutes respectively. None of the measures of pulmonary function used (forced vital capacity, forced expiratory volume in 1 second or maximal midexpiratory flow rate) showed any clinically or statistically significant response to the exposure either immediately after or 8 hours after its beginning. There were no statistically significant differences between the responses of the group that had previously complained of adverse effects and of the group that had not. There was no evidence that either formaldehyde or UFFI off-gas operates as a lower airway allergen or important bronchospastic irritant in this heterogeneous population.

Allergens↗
PubMed1982

Double-blind food challenge in the diagnosis of food sensitivity in the adult.

This study is an attempt to determine the role of double-blind food challenge (DBFC) in suspected food sensitivity in the adult as compared wih established tests of food allergy, including the skin test, RAST, and leukocyte histamine release (LHR) to specific food antigens. Twenty-two subjects (ages 18 to 67) with histories of reactions to foods were challenged with freeze-dried food or placebo in opaque dye-free capsules, in increasing doses over a 90 min span to a total of 13 to 15 gm. This was repeated twice at weekly intervals by similar DBFC. DBFC was preceded by skin testing and venapuncture for RAST and LHR studies. Patients were kept under observation for 2 hr, after which each was asked to maintain a detailed diary of related symptoms and food ingested over the following week. Of 46 DBFCs, 13 (21%) were positive. The correlation with positive skin tests and positive DBFC was 4/13 (30%). The correlation with positive LHR and positive DBFC was lower at 2/13 (15%), and 1/13 (7.6%) with RAST. We concluded that DBFC is an effective test of adult food sensitivity compared with tests usually performed and should be used when the diagnosis is in doubt.

Adult↗
PubMed1978

Hereditary angioneurotic edema and Charcot-Marie-Tooth disease in the same family.

In one family two genetic diseases were transmitted as autosomal dominant traits; hereditary angioneurotic edema was inherited from the paternal side and Charcot-Marie Tooth disease from the maternal side of the family. The conditions occurred separately in 8 and 11 members respectively and together (an exceedingly rare occurrence) in 3. Of six siblings, two girls and four boys, all had Charcot-Marie-Tooth disease, and three, the two girls and one of the boys, also had hereditary angioneurotic edema.

Adolescent↗
PubMed1977

Immediate hypersensitivity to tuberculin. In vivo and in vitro studies.

Immediate responses of hypersensitivity to skin testing with purified derivative of tuberculin (PPD) were observed in 2.3 percent of 3,248 patients seen in an allergy clinic, and the relationship to delayed responses was questioned. Immediate cutaneous reactions to testing with PPD appeared in all age groups and occurred in nonatopic patients but were more common in atopic patients (p less than 0.005). Delayed cutaneous reactions to testing with PPD occurred in only three out of 76 patients with immediate reactivity. Antihistaminic suppression of immediate reactivity was not followed by evidence of delayed cutaneous reactivity. In vitro tests of lymphocytic stimulation revealed indices of stimulation with PPD to be similar both in patients with immediate and delayed cutaneous reactivity. Failure to manifest delayed cutaneous reactivity following immediate cutaneous reactions alone may be explained by antigen-antibody binding and phagocytosis, by suppressor T-lymphocytes, or by impaired release or lack of response to T-lymphocytic mediators. Adverse reactions to administration of BCG vaccine in patients with immediate cutaneous reactivity might be anticipated.

Adolescent↗
PubMed1976

Direct leukocyte migration inhibition in multiple sclerosis--a possible assessment of activity.

Twenty-four patients with multiple sclerosis were evaluated and classified according to their clinical state. Specific migration inhibition studies were carried out on blood samples from each using myelin basic protein, an acid soluble protein fraction isolated from normal human CNS white matter, and multiple sclerosis myelin basic protein isolated from patients who had the disease, as the antigenic material. This test system employed selected media. Results were compared with those of normal controls and patients with other neurological disease states. Antigen concentration of 500 mu g/ml in serum free medium combined to produce the greatest inhibiting effect on leukocytes in patients with apparent multiple sclerosis and differentiated these patients from those in the other groups tested. Leukocytes in patients who had probable multiple sclerosis with partial impairment, signifying possible current activity of the disease, were especially inhibited as compared to the leukocytes from other groups tested against myelin antigen. Cerebrospinal fluid from affected patients when used as a media enhanced the test. This study suggests that migration inhibition of peripheral leukocytes using myelin protein may be useful in the diagnosis of patients with multiple sclerosis. There is additional evidence that the degree of leukocyte migration inhibition may reflect activity of the disease with its consequent implications on treatment and prognosis.

Antigens↗