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Biomedical subjects

J T Connell

Publications and source records attributed to J T Connell.

At least 19 recordsLinked to original sources
PubMed1991

Intranasal fluocortin butyl in patients with perennial rhinitis: a 12-month efficacy and safety study including nasal biopsy.

Fluocortin butyl (FCB) is a recently developed topical intranasal corticosteroid that is inhaled as a powder and has been demonstrated to be well tolerated and to improve symptoms and signs of perennial rhinitis in previous short-term studies. This multicenter, open-label study evaluated the efficacy and safety of FCB during a 12-month treatment period in patients with perennial rhinitis. Treatment was initiated with one inhalation of FCB in each nostril three times a day (total dosage, 3 mg/day). In subsequent months, one third of the patients was maintained at the dosage of 3 mg/day, one third at a lower dosage of 2 mg/day, and the remaining one third of the patients at a larger dosage of 4 to 8 mg/day. Of 109 patients enrolled in the study, 90 patients (82.6%) completed all 12 months of treatment. Symptom and sign scores decreased significantly (p less than 0.001) at the 2-month evaluation compared to scores at baseline, and the improvement was maintained throughout the 12-month study period. After 12 months, greater than 80% of the patients had substantial control of symptoms. Specimens of nasal biopsies, performed at the beginning and end of treatment, revealed a decrease in eosinophils and other cellular infiltrates, a slight tendency of an increase in mast cell counts, and a trend toward normalization of the nasal mucosa. There were few adverse effects. Mean plasma cortisol levels were normal before and after corticotropin stimulation at baseline and after 12 months of FCB therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intranasal↗
PubMed1991

Double-blind comparison of cetirizine and placebo in the treatment of seasonal rhinitis.

The efficacy and safety of cetirizine were evaluated in 419 patients with seasonal allergic rhinitis. Using a 4-way, double-blind randomization schedule, patients were given a 1-week course of once daily cetirizine (5, 10, or 20 mg) or placebo. Patient and physician efficacy ratings corresponded, indicating superiority of cetirizine to placebo (P less than .05) in reducing symptom severity scores for sneezing, rhinorrhea, ocular pruritus, nasal pruritus, watering of the eyes, and redness of the eyes. All cetirizine doses achieved higher efficacy ratings (72.7%, 79.2%, and 75.7%, respectively) than placebo (52.9%; P less than .05) by the physician's global assessment. Cetirizine was well tolerated, with sedation being the most common adverse experience, increasing in frequency at higher doses. A dose-response relationship was evident for selected symptoms, and the once daily 5-mg dose was found to be an effective minimum dose.

Adult↗
PubMed1989

The effectiveness of the nonsedating antihistamine loratadine plus pseudoephedrine in the symptomatic management of the common cold.

A multicentered trial compared the effects of the non-sedating antihistamine, loratadine, 5 mg plus pseudoephedrine 120 mg with a placebo on the signs and symptoms of the common cold. One hundred forty-two (142) subjects were treated with the loratadine/pseudoephedrine combination and 141 subjects were treated with placebo twice daily for five days. Evaluations by both subjects and physicians suggest that this antihistamine/decongestant combination is superior to placebo in relieving symptoms of the common cold. Specific differences were found in symptoms including nasal congestion, sneezing, postnasal drainage, and nasal discharge. Differences between groups for the following side effects were found: dry mouth (9% for the combination vs 2% for placebo), insomnia (6% vs 3%), and nervousness (4% vs 2%). There were no differences between groups for the frequency of drowsiness.

Adolescent↗
PubMed1988

Multicenter, double-blind, multiple-dose, parallel-groups efficacy and safety trial of azelastine, chlorpheniramine, and placebo in the treatment of spring allergic rhinitis.

Azelastine, a novel antiallergic medication, was compared with chlorpheniramine maleate and placebo for efficacy and safety in the treatment of spring allergic rhinitis in a multicenter, double-blind, multiple-dose, parallel-groups study. One hundred fifty-five subjects participated. Subjects ranged in age from 18 to 60 years of age and had at least a 2-year history of spring allergic rhinitis, confirmed by positive skin test to spring aeroallergens. Medications were given four times daily; the azelastine groups received 0.5, 1.0, or 2.0 mg in the morning and evening with placebo in the early and late afternoon; the chlorpheniramine group received 4.0 mg four times daily. Daily subject symptom cards were completed during a screening period to assess pretreatment symptoms and during a 4-week treatment period while subjects received study medications. Individual symptoms, total symptoms, and major symptoms were compared to determine efficacy of medication. Elicited, volunteered, and observed adverse experiences were recorded for each subject and compared among groups. Vital signs, body weights, serum chemistry values, complete blood cell counts, urine studies, and electrocardiograms were obtained for each subject and compared among groups. Symptoms relief in the group receiving the highest concentration of azelastine (2.0 mg twice daily) was statistically greater than in the placebo group during all weeks of the study. Lower doses of azelastine were statistically more effective than placebo only during portions of the first 3 weeks of the study. In contrast, although the chlorpheniramine group did have fewer symptoms than the placebo group during the study, the difference never reached statistical significance during any week of the study. There were no serious side effects in any of the treatment groups. Drowsiness and altered taste perception were increased significantly over placebo only in the high-dose azelastine group. Azelastine appears to be a safe, efficacious medication for seasonal allergic rhinitis.

Adolescent↗
PubMed1987

Safety and efficacy of loratadine (Sch-29851): a new non-sedating antihistamine in seasonal allergic rhinitis.

Loratadine, a new antihistamine in the non-sedating class, was evaluated for efficacy and safety in treatment of allergic rhinitis in a multicentered study. Loratadine was found to be both safe and efficacious. When administered to patients with seasonal allergic rhinitis, a single daily oral dose of 10 mg is comparable in efficacy to clemastine, 1 mg, given twice daily. The incidence of sedation with loratadine is comparable to placebo and significantly lower than with clemastine. The incidence of anticholinergic side effects with loratadine is low and in this study was comparable to placebo and clemastine.

Capsules↗
PubMed1984

Efficacy of a timed-release antihistamine/decongestant tablet for symptoms of nasal allergy.

In a double-blind study, a timed-release tablet containing carbinoxamine maleate 8 mg and pseudoephedrine hydrochloride 120 mg was compared with placebo for the treatment of signs and symptoms of nasal allergy. Ninety-four adults with rhinitis caused by grass or ragweed allergy were paired according to severity of symptoms and nasal congestion, then assigned randomly to drug or placebo. After baseline measurements were taken, three doses of drug or placebo were given at 12-hour intervals. The active drug was significantly better than placebo in relieving the following symptoms: nasal congestion, nose blowing, sneezing, nasal pruritus, rhinorrhea, ophthalmic pruritus, and sniffles. Improvement over baseline in mean total nasal air flow also was greater in subjects given active drug. The incidence of nonspecific symptoms, including possible drug side effects, was similar between groups. We conclude that the timed-release tablet is safe and effective therapy for the treatment of signs and symptoms of nasal allergy.

Adult↗
PubMed1983

Nasal disease: mechanisms and classification.

Nasal tissues can be affected by a greater variety of stimuli than is generally considered, stimuli which can produce many different diseases. The manner in which the nose can respond symptomatically and physically is limited so that symptoms and findings in different diseases frequently overlap and the conditions may be difficult to diagnose. An understanding of nasal diseases is only in its infancy. This report outlines some of these diseases and speculates about the presence of others. Classification of nasal disease is presented based on the suspected presence or absence of an immunological mechanism.

Chronic Disease↗
PubMed1982

Rhinometry: measurement of nasal patency.

Airflow through the nose is a complex function since the nose is a tortuous series of channels. Mathematicians can only guess at formulas which would explain the intricacies of the nasal passages and flow of air through them. For practical purposes a "black box technique" may be used in which input and output are measured at either end of the black box (the nose). A very useful and accurate measure of nasal patency is obtained from these measurements. Rhinometry has been limited in research environment but is now feasible for clinical practice. With the advent of simpler techniques and improved instruments any physician can be trained to do rhinometry.

Adolescent↗
PubMed1979

Immunological parameters in perennial rhinitis.

As part of a study of the effectiveness of beclomethasone dipropionate in perennial rhinitis five immunologically related parameters were measured. These included skin tests, total IgE, specific IgE, nasal and peripheral blood eosinophil counts. In addition, nasal biopsies were obtained in twenty out of sixty patients. It was apparent that patients with perennial rhinitis formed a heterogeneous group who could be divided into three groups based on the extent of immunological abnormality detected. Group 1 consisted of twenty patients who displayed no abnormality in any of the five parameters studied. Group 2 consisted of twenty-six patients in whom specific IgE was not detected but who had varying degrees of abnormal findings in the other laboratory parameters. The remaining fourteen patients formed a third group in whom specific IgE was detected in addition to abnormalities in other parameters. In general, patients with detectable specific IgE had a higher frequency of abnormal parameters, including abnormal histology of their nasal biopsy, than patients in whom no specific IgE was detected. The heterogeneous nature of perennial rhinitis is discussed. Despite the heterogeneous nature of the total patient group, the majority of patients (80%) treated with beclomethasone dipropionate improved compared to 20% improved in the placebo group. There was no difference in the drug effect between the three groups of patients.

Adolescent↗
PubMed1979

Localization of IgE in tissues by an immunoperoxidase technique.

An indirect immunoperoxidase technique was used to study the content and distribution of IgE in formaldehyde solution-fixed, paraffin-embedded adenoid and nasal tissues of atopic and nonatopic persons. Adenoid tissue from 15 patients, and nasal tissue from five patients with symptoms of inhalant allergies and augmented serum levels of total and allergen-specific IgE were examined with this method. Adenoid tissues from five patients without allergic symptoms were studied for comparison. A rich content of IgE, largely within the cytoplasm of the plasma cells, was observed in tissues of atopic subjects. The sections from nonallergic persons contained few weakly staining IgE-positive cells. These observations provide anatomic support for the role of IgE in hypersensitivity reaction of immediate type. This immunoperoxidase technique, circumventing the principal shortcomings of the immunofluorescence procedures, affords a highly sensitive and practical approach to cellular and tissue localization of IgE.

Adenoids↗
PubMed1979

An immunoperoxidase assay for serum ragweed-specific IgE.

A solid-phase enzyme immunoassay for allergen-specific IgE antibodies in serum is descirbed. In this technique these antibodies are allowed to bind to the allergen previously adsorbed to the wells of polystyrene microtiter plates. After a washing step the tubes are incubated with rabbit antihuman IgE labelled with horseradish peroxidase. Following a second washing step, the enzyme bound to the tubes is assayed spectrophotometrically using O-phenylene diamine as the substrate. The standard curves obtained with this method and with the RAST technique are illustrated. For the assay of serum antiragweed IgE antibodies, concordance between the results obtained with the RAST test and this immunoperoxidase assay was observed in 85 or 95 (90%) patients with symptoms of ragweed hayfever. The coefficients of variation ranged from 4.4% (2SD +/- .010) TO 14% (2SD +/- .008). The advantages of using peroxidase as the enzymatic marker for the assay of allergen-specific IgE are discussed.

Allergens↗
PubMed1979

A novel method to assess antihistamine and decongestant efficacy.

A method has been developed to equalize as many of the variables as possible in a clinical trial to assess the response to medication in allergic rhinitis. This method was used to study the effectiveness of azatadine maleate and pseudoephedrine sulfate alone and in combination. Azatadine effectively relieved symptoms of hay fever but did not reduce nasal congestion to a significant degree. Pseudoephedrine relieved nasal congestion but did not reduce symptoms. The combination of azatadine and pseudoephedrine relieved both symptoms and congestion.

Clinical Trials as Topic↗