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Biomedical subjects

D H Richards

Publications and source records attributed to D H Richards.

At least 19 recordsLinked to original sources
PubMed1996

Fluticasone propionate aqueous nasal spray: a well-tolerated and effective treatment for children with perennial rhinitis.

A total of 535 children aged 4-11 years with perennial rhinitis were recruited to two double-blind studies performed at 56 centres in eight European countries, Israel, and South Africa. One study compared the efficacy and tolerability of fluticasone propionate aqueous nasal spray (FPANS), at either 100 micrograms once daily (od) or 100 micrograms twice daily (bd), with beclomethasone dipropionate (BDPANS) 200 micrograms bd for 12 weeks in 120 children aged 6-11 years. The second study compared FPANS 100 micrograms od with FPANS 200 micrograms od and placebo for 4 weeks in 415 children aged 4-11 years. Efficacy was determined by means of patient assessments of nasal symptoms of perennial rhinitis and by investigator assessments of symptoms and nasal condition. The symptoms of nasal blockage, on waking and during the day, sneezing, rhinorrhoea, and nasal itching were assessed by the investigator at clinic visits and by the completion of a patient daily diary card. Safety was assessed by collection of adverse event information, routine haematology and biochemistry testing, and monitoring plasma cortisol levels. FPANS demonstrated good control of symptoms at each dose regimen, which was equivalent or superior to BDPANS and superior to placebo. There was no difference between the dose regimens of FPANS. FPANS was as well tolerated as placebo and BDPANS. It is concluded that FPANS 100 micrograms od is an effective and well-tolerated treatment for perennial rhinitis in children aged 4-11 years.

Aerosols↗
PubMed1995

A placebo-controlled study of fluticasone propionate aqueous nasal spray and beclomethasone dipropionate in perennial rhinitis: efficacy in allergic and non-allergic perennial rhinitis.

BACKGROUND: Fluticasone propionate is a new potent, topically active corticosteroid with negligable oral bioavailability. Data on its comparative efficacy in perennial allergic and non-allergic rhinitis are limited. OBJECTIVE: To compare the efficacy and safety of fluticasone propionate aqueous nasal spray (FPANS) 200 micrograms once or twice daily with beclomethasone dipropionate aqueous nasal spray (BPD) 200 micrograms twice daily and placebo in patients with allergic and non-allergic perennial rhinitis. METHODS: The 12-week study had a multicentre, double-blind, randomized, parallel group design. Efficacy was assessed from symptom scores recorded on daily diary cards. RESULTS: FPANS 200 micrograms once or twice daily was significantly better than placebo but not better than BDP in relieving the nasal symptoms of rhinitis. FPANS at either dose was equally effective in the treatment of allergic and non-allergic perennial rhinitis. There were few adverse events and no treatment-related abnormalities in laboratory measurements in either FPANS-treated group. Comparison between treatment groups indicated that FPANS was as well tolerated as placebo and BDP at the doses studied. CONCLUSIONS: In the majority of patients FPANS 200 micrograms once daily in as effective as BDP 200 micrograms twice daily in the relief of perennial allergic rhinitis.

Administration, Intranasal↗
PubMed1995

The lack of effect of benzalkonium chloride on the cilia of the nasal mucosa in patients with perennial allergic rhinitis: a combined functional, light, scanning and transmission electron microscopy study.

BACKGROUND: Controversy still exists about the effect of 0.02% benzalkonium chloride (BKC), a preservative in many nasal sprays, on human nasal epithelium in vivo. OBJECTIVE: To determine the safety of BKC by assessing its effect on the function and morphology of cilia of human nasal epithelium. METHODS: A single-centre, double-blind nasal biopsy study in 22 patients with perennial allergic rhinitis, receiving fluticasone propionate aqueous nasal spray (FPANS) containing BKC, BKC plus placebo or placebo alone for 6 weeks. Before, at two weekly intervals during treatment and 2 weeks after treatment ceased an indigocarmine saccharine transport time (ICST) was performed. RESULTS: ICST results did not significantly vary between the groups. There was no statistical relationship between the number of ciliated cells present and the treatment the patients received. Scanning and transmission electron microscopy examination showed no effects of BKC. CONCLUSION: Despite reports of its ciliostatic effects in vitro, BKC did not have such an effect when it was applied for 6 weeks (with/without fluticasone propionate) to the nasal mucosa of perennial allergic rhinitis patients in vivo.

Adolescent↗
PubMed1995

The efficacy and tolerability of fluticasone propionate aqueous nasal spray in children with seasonal allergic rhinitis.

Fluticasone propionate aqueous nasal spray (FPANS) contains fluticasone propionate, which is a new topically active glucocorticoid with approximately twice the potency of belcomethasone dipropionate. In this European multicentre study, 143 children with seasonal allergic rhinitis were recruited: 47 received FPANS 100 micrograms once a day (od), 46 received FPANS 200 micrograms od, and 50 patients received placebo od, for 4 weeks. Treatment efficacy was assessed using diary card nasal symptom scores for sneezing, rhinorrhoea, blockage and itching, and eye watering/irritation. Patients receiving FPANS 100 micrograms or FPANS 200 micrograms demonstrated statistically significant improvements in median nasal symptom scores in all the symptoms recorded, when compared with placebo. There were no statistically significant differences between the FPANS 100 micrograms and FPANS 200 micrograms groups in improvement in nasal symptom scores. There was no effect on eye watering/irritation symptoms which could be attributed to either FPANS 100 micrograms or FPANS 200 micrograms when compared with placebo. Use of rescue antihistamine medication was significantly reduced in the FPANS 100 micrograms group when compared with placebo. The adverse events profile was similar in all three treatment groups, and the events reported were generally mild and related to the patients' rhinitis.

Administration, Inhalation↗
PubMed1995

Once daily fluticasone propionate aqueous nasal spray controls symptoms of most patients with seasonal allergic rhinitis.

This multicentre, randomized, double-blind, parallel-group study was designed to compare the efficacy and tolerability of fluticasone propionate aqueous nasal spray 200 micrograms once daily (FPANS 200 micrograms od) with FPANS 200 micrograms twice daily (bd) in patients whose seasonal rhinitis symptoms were not completely controlled with FPANS 200 micrograms od. A total of 549 patients initially received FPANS 200 micrograms od during the open-treatment phase of the study. After 2 weeks, 65% of patients had their symptoms well controlled by FPANS 200 micrograms od and continued with this treatment for a further 2 weeks. The remainder received either FPANS 200 micrograms od or FPANS 200 micrograms bd for a further 2 weeks. Efficacy was evaluated by the analysis of symptom-free days. In the uncontrolled group, there was a significant increase in the percentage of symptom-free days in the FPANS 200 micrograms bd group over the FPANS 200 micrograms od group for nasal blockage on waking (P < 0.05) and nasal blockage during the day (P < 0.05). Similar trends were observed for sneezing, rhinorrhoea, nasal itching, and eye symptoms. There was a significant increase in the percentage of days with a symptom score of less than 2 in FPANS 200 micrograms bd group for nasal blockage during the day (P < 0.05). Adverse events were similar in nature and frequency in each treatment group. It is concluded that in the majority of patients symptoms of seasonal rhinitis are well controlled by FPANS 200 micrograms od. In the minority of patients whose symptoms are not adequately controlled by a once daily dose, FPANS 200 micrograms bd provides additional relief, particularly from nasal blockage.

Administration, Intranasal↗
PubMed1994

A double-blind comparison of fluticasone propionate aqueous nasal spray, terfenadine tablets and placebo in the treatment of patients with seasonal allergic rhinitis to grass pollen.

Fluticasone Propionate Aqueous Nasal Spray (FPANS) contains a topically active glucocorticoid fluticasone propionate which has been used successfully for the treatment of seasonal allergic rhinitis. This multicentre, randomized, double-blind, double-dummy, placebo-controlled, parallel group study was designed to compare the efficacy and tolerability of FPANS with terfenadine tablets or placebo in controlling the symptoms of allergic rhinitis to grass pollen. Two hundred and fourteen patients were treated for 6 weeks during the grass pollen season with either FPANS 200 micrograms once daily, terfenadine tablets (60 mg) twice daily or placebo. Efficacy was evaluated by the analysis of symptom-free days and median symptom scores. Patients receiving FPANS had significantly more days free of nasal blockage on waking (P = 0.012) and during the day (P = 0.01) and of rhinorrhoea (P = 0.027) than those receiving terfenadine. Additionally, in terms of absolute efficacy, patients receiving FPANS demonstrated significantly more days free of the above symptoms (P = 0.017, P = 0.028, P = 0.004, respectively) and of sneezing (P < 0.001) than those receiving placebo. There were no significant differences in symptoms of nasal itching, eye symptoms, of symptoms of drowsiness between the three treatment groups. Patients in the FPANS group had significantly lower median symptom scores for nasal blockage on waking (P < 0.001) and during the day (P < 0.018) than those in the terfenadine group and significantly lower scores for nasal blockage on waking (P < 0.001), sneezing (P < 0.013) and rhinorrhoea (P = 0.005) than those in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Topical↗
PubMed1990

Attenuation of nocturnal asthma by cromakalim.

In a randomised, double-blind, crossover study, single oral doses of cromakalim, a potassium-channel activator, or placebo were given to 23 patients with nocturnal asthma. There was a significant reduction (p less than 0.005) in the early morning fall in forced expiratory volume in 1 s (FEV1) after 0.5 mg cromakalim (fall 9.8% [SEM 3.2%]) compared with placebo (18.5 [2.8]%). In a repeat dosing study, administration of 0.25 mg and 0.5 mg cromakalim on 5 consecutive nights to a further group of 8 asthmatic subjects significantly reduced the early morning fall in FEV1 from 28.7 (6.5)% after placebo to 19 (4.2)% after 0.25 mg and 14.9 (6.5)% after 0.5 mg. Potassium-channel activators may be useful in the treatment of asthma, especially for nocturnal symptoms.

Adult↗
PubMed1988

Studies in healthy volunteers can demonstrate bronchodilator activity of orally administered drugs.

A panel of healthy volunteers was screened by bronchial histamine provocation. The response used was the flow rate achieved during a partial forced expiratory manoeuvre at a lung volume 30% of the vital capacity above the residual volume. Those subjects who were relatively sensitive to the bronchoconstrictor effects of inhaled histamine took part in a reproducibility study. Those with consistent responses took part in a further study in which the bronchodilator, and bronchoconstriction-protective, effects of orally administered chlorpheniramine, terfenadine and salbutamol were investigated. The technique was able to demonstrate the efficacy of these drugs in non-patient volunteers. Thus it seems to be a suitable method for the early evaluation, in man, of certain drugs with an anti-asthma therapeutic potential. It also provides useful information on the dose and duration of action of compounds prior to the first efficacy trials in patients.

Administration, Oral↗
PubMed1981

Metabolism of 1,3-dibromopropane.

Oral administration of 1,3-dibromopropane (2 mmol/kg) to rats resulted in a marked decrease in the level of hepatic glutathione (GSH). Sulphur-containing [14C]-metabolites were excreted in the bile of rats dose with 1,3-bromo[14C]propane and were subjected to enterohepatic cycling. After an oral dose of 1,3-dibromo[14C]propane, peak levels of radioactivity were rapidly attained in the blood and were maintained for several hours; approximately equal amounts of radioactive material were excreted in urine and expired air. Several radioactive metabolites were excreted in urine; a major metabolite was N-acetyl-S-[1-bromo-3-propyl]-cysteine.

Animals↗
PubMed1980

The effect of compactin, a potent inhibitor of 3-hydroxy-3-methylglutaryl coenzyme-A reductase activity, on cholesterogenesis and serum cholesterol levels in rats and chicks.

Compactin, [7-(1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methylbutyrylox)naphthyl)-3-hydroxyheptan-5-olide], a potent competitive inhibitor of the rate-determining step in cholesterol biosynthesis, was used to study the influence of changes in cholesterogenesis on serum cholesterol levels. Up to 3 h after a single oral dose (20 or 50 mg/kg) or after the last of a series of daily oral doses (50 mg/kg for 7 or 28 days) to young, male normolipidaemic rats, compactin consistently inhibited cholesterogenesis measured using 3H20 in liver, ileum and other extrahepatic tissues without affecting fatty acid synthesis. Compactin did not reduce serum or tissue cholesterol nor affect the serum concentration of other lipids nor the ratio between lipoprotein classes. A diurnal variation in the effect of compactin on cholesterogenesis was observed. For example, by 12--20 h after dosing, cholesterogenesis at all sites was increased above the comparable control value, indicating the induction of enzyme synthesis and overall there was little effect on the mass of cholesterol synthesized per day. Similar results were obtained using male chicks. Inhibition of cholesterogenesis by compactin was also observed in cholestyramine-treated rats, in which cholesterol turnover was markedly increased, and even in cholesterol-fed rats, in which cholesterogenesis already was repressed. In neither case, however, was inhibition of cholesterogenesis accompanied by a hypocholesterolaemic effect. It is concluded that a more persistent suppression of cholesterogenesis, than that observed with compactin in the rat, may be required in order to affect serum cholesterol concentrations.

Animals↗