Treatment of Chronic Childhood Asthma With Beclomethasone Dipropionate Aerosol: I. A Double-Blind Crossover Trial in Nonsteroid-Dependent Patients

PEDIATRICS ◽  
1977 ◽  
Vol 60 (1) ◽  
pp. 7-13
Author(s):  
Robert Klein ◽  
David Waldman ◽  
Harvey Kershnar ◽  
William Berger ◽  
Anne Coulson ◽  
...  
Keyword(s):  
Beclomethasone Dipropionate ◽  
Placebo Treatment ◽  
Forced Expiratory Volume ◽  
Adrenal Function ◽  
Double Blind ◽  
Medication Score ◽  
Hormone Responses ◽  
The Mean ◽  
Double Blind Crossover Study ◽  
Chronic Childhood

Twenty-two children with chronic asthma requiring daily administration of bronchodilators but not steroids were administered 400 µg of beclomethasone dipropionate aerosol (BDA) or a placebo (vehicle) in a double-blind crossover study. The experimental design consisted of four study periods (four weeks each): (1) baseline, (2) BDA or placebo treatment, (3) washout, (4) BDA or placebo treatment. Evaluation of effectiveness was assessed by daily symptom and medication scores, Wright Peak Flow (WPF) measurements three times each day, and weekly spirometry. Pituitary-adrenal function was evaluated by diurnal measurement of cortisol level, intravenous (IV) metyrapone tests, and IV adrenocorticotropic hormone responses. Quantitative throat cultures for Candida were taken monthly. Twenty-one of 22 patients correctly identified BDA. The mean weekly symptom score was 76.5 ± 10.8 (mean ± SE) during placebo compared to 21.3 ± 5.3 during BDA therapy (P < .005). The number of attacks per week was 7.1 ± 1.4 in those receiving placebo and 1.6 ± 0.6 in those receiving BDA (P < .005). Mean medication score was 39.6 ± 3.6 during placebo and 21.6 ± 1.3 during BDA therapy (P < .005). Mean weekly average WPF measurements increased 33% with BDA therapy compared to placebo. Eighty percent of patients showed an increase in forced expiratory volume in one second and in maximum midexpiratory flow rate during BDA therapy. All throat cultures were negative. No pituitary-adrenal function suppression was noted in any of the parameters studied. BDA was shown to be highly effective in controlling asthma and produced no adverse effects.

Effect Of Diet And Clofibrate On Increased Platelet Function In Hyperlipoproteinemia

1981 ◽  
Author(s):  
J H Joist ◽  
R K Baker ◽  
G Schonfeld
Keyword(s):  
Platelet Function ◽  
Placebo Treatment ◽  
Lipid Lowering ◽  
Double Blind ◽  
Serum Triglycerides ◽  
Coagulant Activity ◽  
Respective Type ◽  
The Mean ◽  
Double Blind Crossover Study ◽  
Observation Period

We have previously reported shortened template bleeding times (BT) in patients with type IIb and IV-hyperlipoproteinemia (HLP) and increased platelet coagulant activity (PF3a) in patients with types IIa, IIb and IV-HLP. We now report on a randomized, double-blind crossover study designed to assess the efficacy of lipid lowering diets appropriate for the respective type of HLP and Clofibrate versus placebo in reversing platelet hypersensitivity. 8 patients with IIa, 9 patients with IIb, and 9 patients with IV-HLP completed the study which included (a) baseline study (regular diet), (b) controlled diet (2 months), (c) controlled diet and Clofibrate (6 months), (d) controlled diet and placebo (6 months) (crossover design). In IIa-HLP patients the mean BT remained significantly shortened throughout all study periods whereas PF3a had reversed to normal at the end of the diet period without significant further changes thereafter. In IIb- and IV-HLP patients both shortened BT and increased PF3a observed at baseline normalized at the end of the diet period with a continuous further decline of PF3a thereafter regardless of Clofibrate or placebo. A small but significant decrease in total and LDL-cholesterol in serum was observed during the diet period in IIa-HLP patients and this decrease was not enhanced by Clofibrate. In IV-HLP patients, serum triglycerides had declined by 50% at the end of the diet period and stabilized at 25% of the initial value at the end of the first 6 month treatment period irrespective of Clofibrate or placebo treatment. No significant changes in triglyceride levels were observed in IIa- or IIb-HLP patients throughout the 14 month observation period. The findings indicate that lipid lowering diets may reverse platelet hypersensitivity in HLP patients and that Clofibrate has no effect on platelet function in HLP patients on a controlled lipid lowering diet.

Pharmacokinetics and Tolerability of Factor XIII Concentrates Prepared from Human Placenta or Plasma: a Crossover Randomised Study

1995 ◽  
Vol 74 (02) ◽  
pp. 622-625 ◽  
Author(s):  
H H Brackmann ◽  
R Egbring ◽  
A Ferster ◽  
P Fondu ◽  
J M Girardel ◽  
...  
Keyword(s):  
Factor Xiii ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Randomised Study ◽  
The Mean ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study ◽  
Fxiii Activity ◽  
Observation Period

SummaryThe pharmacokinetics and tolerability of factor XIII (FXIII) from plasma were compared with those of FXIII from placenta in a randomised, double-blind, crossover study involving 13 patients with congenital FXIII deficiency. Both FXIII activity and FXIII antigen were monitored. No difference was seen in the mean half-lives of the two preparations (9.3 days and 9.1 days for plasma and placenta FXIII activity, respectively). Response was similar for both preparations, but was slightly greater for FXIII from plasma.Similar results were found for recovery (65% vs 60%). The area under the data completed by extrapolation was significantly higher for FXIII from plasma. No differences between preparations in terms of efficacy or tolerability were observed. It can be concluded that treatment with FXIII concentrate from plasma is as efficient as with FXIII concentrate from placenta in terms of recovery and half-life. Both preparations were equivalent in terms of safety during the observation period. With the administration of monthly injections of approximately 30 U/kg serious bleeding events were prevented and no other serious adverse events occurred.

scholarly journals Nociceptive mechanisms modulate ozone-induced human lung function decrements

1998 ◽  
Vol 85 (5) ◽  
pp. 1863-1870 ◽  
Author(s):  
Anthony N. Passannante ◽  
Milan J. Hazucha ◽  
Philip A. Bromberg ◽  
Elston Seal ◽  
Larry Folinsbee ◽  
...  
Keyword(s):  
Lung Function ◽  
Intermittent Exercise ◽  
Forced Expiratory Volume ◽  
Endogenous Opioids ◽  
Functional Responses ◽  
Double Blind ◽  
C Fibers ◽  
Impaired Lung Function ◽  
Opioid Receptor Agonists ◽  
Double Blind Crossover Study

We have previously suggested that ozone (O3)-induced pain-related symptoms and inhibition of maximal inspiration are due to stimulation of airway C fibers (M. J. Hazucha, D. V. Bates, and P. A. Bromberg. J. Appl. Physiol. 67: 1535–1541, 1989). If this were so, pain suppression or inhibition by opioid-receptor agonists should partially or fully reverse O3-induced symptomatic and lung functional responses. The objectives of this study were to determine whether O3-induced pain limits maximal inspiration and whether endogenous opioids contribute to modulation of the effects of inhaled O3 on lung function. The participants in this double-blind crossover study were healthy volunteers (18–59 yr) known to be “weak” (WR; n = 20) and “strong” O3 responders (SR; n = 42). They underwent either two 2-h exposures to air or two 2-h exposures to 0.42 parts/million O3 with moderate intermittent exercise. Immediately after post-O3 spirometry, the WR were randomly given either naloxone (0.15 mg/kg iv) or saline, whereas SR randomly received either sufentanil (0.2 μg/kg iv) or saline. O3 exposure significantly ( P < 0.001) impaired lung function. In SR, sufentanil rapidly, although not completely, reversed both the chest pain and spirometric effects (forced expiratory volume in 1 s; P < 0.0001) compared with saline. Immediate postexposure administration of saline or naloxone had no significant effect on WR. Plasma β-endorphin levels were not related to an individual’s O3responsiveness. Cutaneous pain variables showed a nonsignificant weak association with O3responsiveness. These observations demonstrate that nociceptive mechanisms play a key role in modulating O3-induced inhibition of inspiration but not in causing lack of spirometric response to O3 exposure in WR.

Comparison of a New Hypnotic (Finorgal) with Placebo in a Double-Blind Trial

1979 ◽  
Vol 7 (5) ◽  
pp. 387-390
Author(s):  
Gianni Baiotti
Keyword(s):  
Placebo Treatment ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
The Mean ◽  
Mean Time

The hypnotic effects of Finorgal (ethchlorvynol with diphenhydramine) were compared with those of placebo in a double-blind study with crossover of treatments in thirty-five hospital in-patients. During the four-week period of Finorgal treatment there was a significant reduction in the mean time elapsing between the administration of the hypnotic and the onset of sleep, and a significant increase in the duration of sleep, compared with the four weeks of placebo treatment. There was also a significant increase in the proportion of nights when the patients felt they had slept well, and in the incidence of morning ‘hangover’ and nocturnal confusion during the Finorgal treatment periods. Patients had to be actively woken in the morning significantly more often following Finorgal administration. In patients experiencing pain in the night there was a significant reduction in the occurrence of pain during the nights when Finorgal had been given.

Minor Aphthous Oral Ulceration: A Double-Blind Cross-Over Study of Beclomethasone Dipropionate Aerosol Spray

1989 ◽  
Vol 34 (5) ◽  
pp. 531-532 ◽  
Author(s):  
A.C. Thompson ◽  
A. Nolan ◽  
P.-J. Lamey
Keyword(s):  
Washout Period ◽  
Whole Blood ◽  
Beclomethasone Dipropionate ◽  
Oral Ulceration ◽  
Double Blind ◽  
Duration Of Effect ◽  
Aerosol Spray ◽  
Aphthous Ulceration ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

A double-blind crossover study is described of the effect of beclomethasone dipropionate aerosol spray in patients with recurrent (minor) aphthous oral ulceration. Patients included in the study had normal haematological parameters of haemoglobin, ferritin, vitamin B12 and corrected whole blood folate. The design of the study incorporated a washout period and duration of effect was evaluated up to six months. Beclomethasone dipropionate significantly reduced ulcer pain severity and ulcer frequency, but had no significant effect on recurrence of oral ulceration. The preparation was associated with a high patient compliance and has benefit in relieving symptoms in patients with recurrent minor aphthous ulceration.

The Antihypertensive Effect of Verapamil in Twice and Thrice Daily Dose Regimens. A Randomized, Double-Blind, Crossover Trial

1983 ◽  
Vol 11 (3) ◽  
pp. 190-193 ◽  
Author(s):  
B Hedbäck ◽  
K Parment
Keyword(s):  
Dose Regimen ◽  
Crossover Trial ◽  
Antihypertensive Effect ◽  
Morning Dose ◽  
Double Blind ◽  
Daily Dose ◽  
The Mean ◽  
Daily Dose Regimen ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

The antihypertensive effect of verapamil 200 mg b.i.d. was compared with that of verapamil 120 mg t.i.d. in a double-blind crossover study in eight out-patients with essential hypertension. The mean supine blood pressure measured before the morning dose was 150/87 mm Hg in patients treated with verapamil 200 mg b.i.d. and 151/87 mm Hg in those treated with verapamil 120 mg t.i.d. The recently reported prolonged half-life and accumulation of verapamil during steady-state conditions explains the lasting antihypertensive effect with the twice-daily dose regimen. Such a twice daily dose regimen is presumed to be more convenient to the patients and thus improve their compliance.

scholarly journals Naltrexone Does Not Relieve Uremic Pruritus

2000 ◽  
Vol 11 (3) ◽  
pp. 514-519
Author(s):  
CHRISTIANE PAULI-MAGNUS ◽  
GERD MIKUS ◽  
DOMINIK M. ALSCHER ◽  
TILLMANN KIRSCHNER ◽  
WILFRIED NAGEL ◽  
...  
Keyword(s):  
Treatment Period ◽  
Placebo Treatment ◽  
Double Blind ◽  
Placebo Period ◽  
Uremic Pruritus ◽  
High Incidence ◽  
Term Administration ◽  
The Difference ◽  
Double Blind Crossover Study ◽  
Μ Receptor

Abstract. Improvement of uremic pruritus was reported under short-term administration of the μ-receptor antagonists naltrexone and naloxone. The aim of the present study was to confirm the efficacy and safety of the oral μ-receptor antagonist naltrexone during a 4-wk treatment period in patients on hemodialysis and peritoneal dialysis. A placebo-controlled, double-blind crossover study of uremic patients with persistent, treatment-resistant pruritus was performed. Of 422 patients screened between December 1997 and June 1998, 93 suffered from pruritus and 23 were eligible for the study. Patients were started either with a 4-wk naltrexone sequence (50 mg/d) or matched placebo. This was followed by a 7-d washout, and patients continued with a 4-wk sequence of the alternate medication. Pruritus intensity was scored daily by a visual analogue scale (VAS) and weekly by a detailed score assessing scratching activity, distribution of pruritus, and frequency of pruritus-related sleep disturbance. Sixteen of 23 patients completed the study. During the naltrexone period, pruritus decreased by 29.2% (95% confidence interval [CI], 18.7 to 39.6) on the VAS and by 17.6% (95% CI, 4.2 to 31.1) on the detailed score. In comparison, pruritus decreased by 16.9% (95% CI, 6.8 to 26.9) on the VAS and by 22.3% (95% CI, 9.3 to 35.2) on the detailed score during the placebo period. The difference between the naltrexone and the placebo treatment period was not statistically significant. Nine of 23 patients complained of gastrointestinal disturbances during the naltrexone period compared with only one of 23 patients during the placebo period (P < 0.05). These results show that treatment of uremic pruritus with naltrexone is ineffective. In addition, a high incidence of adverse effects was observed during treatment with naltrexone.

Cow's Milk Whey Protein Elicits Symptoms of Infantile Colic in Colicky Formula-Fed Infants: A Double-Blind Crossover Study

PEDIATRICS ◽  
1989 ◽  
Vol 83 (2) ◽  
pp. 262-266 ◽  
Author(s):  
Lasse Lothe ◽  
Tor Lindberg
Keyword(s):  
Crossover Study ◽  
Whey Protein ◽  
Cow’S Milk ◽  
Infantile Colic ◽  
Double Blind ◽  
Milk Whey ◽  
Cow's Milk ◽  
The Mean ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

There are several causes of infantile colic. The aim of this study was to evaluate, under controlled conditions, whether bovine whey proteins can elicit symptoms of infantile colic in colicky formula-fed infants. The mean age for entering the study was 6.4 weeks and the mean age for colic debut was 3.7 weeks. In 24 of 27 infants with severe colic, the symptoms disappeared when they were given a cow's milk-free diet (Nutramigen). These 24 infants were entered into a double-blind crossover study. The infants (receiving cow's milk-free diet) were given the contents of identical capsules with each meal during day 6. The same procedure was repeated on day 10. The capsules contained either whey protein powder (with Nutramigen added) or human albumin powder (with Nutramigen added). Eighteen infants receiving the whey protein-containing capsules reacted with colic, two infants receiving placebo reacted with colic (P&lt; .001), and four infants did not react at all. Crying hours per day for the 24 infants were 5.6 hours for formula-fed infants and 0.7 hour for cow's milk-free diet-fed infants (P&lt; .001). Crying hours per day were 3.2 hours for the infants receiving whey protein capsules and 1.0 hour for those receiving placebo (P&lt; .001). In conclusion, bovine whey protein can elicit symptoms of infantile colic in colicky formula-fed infants.

scholarly journals GASTRIC RESIDUAL VOLUME BY MAGNETIC RESSONANCE AFTER INTAKE OF MALTODEXTRIN AND GLUTAMINE: a randomized double-blind, crossover study

2014 ◽  
Vol 51 (2) ◽  
pp. 123-127 ◽  
Author(s):  
Luigi R BRIANEZ ◽  
Cervantes CAPOROSSI ◽  
Yure W de MOURA ◽  
Lorena A DIAS ◽  
Regis V LEAL ◽  
...  
Keyword(s):  
Magnetic Resonance Imaging ◽  
Preoperative Care ◽  
Crossover Fashion ◽  
Residual Volume ◽  
Resonance Imaging ◽  
Gastric Residual Volume ◽  
Double Blind ◽  
The Mean ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

ContextThe addition of glutamine in preoperative drinks may enhance the benefits of carbohydrate alone.ObjectivesTo evaluate the gastric residual volume after the intake of a beverage containing carbohydrate plus glutamine.MethodsEleven healthy volunteers (24-30 years-old) were randomized in a crossover fashion to intake 400 mL (4h before) and 200 mL (2h before) of a beverage containing either 12.5% maltodextrin (carbohydrate group) or 12.5% maltodextrin plus 15 g of glutamine (glutamine group) in two different moments 7 days apart. Magnetic ressonance was performed to measure the gastric residual volume (mL) 120 and 180 minutes after the last ingestion.ResultsGastric residual volume similar to basal condition was found after 2h and 3h of the intake of beverages. There was no difference in the mean ±SD GRV (mL) found at 120 minutes (carbohydrate group: 22.9±16.6 and glutamine group: 19.7±10.7) and at 180 minutes (carbohydrate group: 21.5±24.1 and glutamine group: 15.1±10.1) between the two drinks.ConclusionsGastric emptying is efficient, and occurs in up to two hours after the intake of a beverage containing either carbohydrate alone or carbohydrate associated with glutamine. The addition of glutamine to carbohydrate-enriched drink seems to be safe for the use up to 2h before an operation. HEADINGS - Gastric emptying. Preoperative care. Carbohydrates. Glutamine. Magnetic resonance imaging.

scholarly journals Comparison of Once- with Twice-Daily Dosing of Fluticasone Propionate in Mild and Moderate Asthma

2000 ◽  
Vol 7 (3) ◽  
pp. 239-247 ◽  
Author(s):  
Louis-Philippe Boulet ◽  
Robert L Cowie ◽  
Roberto Dal Negro ◽  
Wade Brett ◽  
Milton Gold ◽  
...  
Keyword(s):  
Fluticasone Propionate ◽  
Asthma Control ◽  
Treatment Guidelines ◽  
Group Versus ◽  
Forced Expiratory Volume ◽  
Double Blind ◽  
Once Daily ◽  
Daily Group ◽  
Moderate Asthma ◽  
The Mean

OBJECTIVES:Two 12-week, randomized, double-blind, parallel-group studies were performed to compare the efficacy and safety of once- and twice-daily dosing of fluticasone propionate (FP) in the treatment of mild to moderate asthma, considered to require the equivalent of either 200 or 500 µg of FP daily.PATIENTS AND METHODS:In study A, 461 patients with asthma received FP either 200 µg once daily or 100 µg twice daily. In study B, 443 patients with asthma received FP, either 500 µg once daily or 250 µg twice daily.RESULTS:In both studies, regardless of the treatment regimen to which patients were randomly assigned, small improvements over baseline were observed in morning peak expiratory flows (PEF) and forced expiratory volume in 1 s (FEV1) following 12 weeks of treatment. In study A, the mean morning PEF improved by 2.4% and 4.3% (once daily versus twice daily, P=0.008).  In study B, the mean morning PEF improvement was 0.2% and 3.7% (once daily versus twice daily, PÃ0.001). For both studies, the increases observed in FEV1were not significantly different between the two groups (P = not significant). The incidence of exacerbations of asthma and related events was 13% and 5%, respectively, in the patients with mild asthma for the once-daily group versus the twice-daily group; these exacerbations were 12% and 10%, respectively, in patients with moderate asthma. Otherwise, the incidence and types of adverse events were comparable for the two treatment regimens. Although twice-daily dosing demonstrated small but statistically significant improvements over once-daily dosing, patients of both groups generally maintained a good level of asthma control on both regimens according to current treatment guidelines.CONCLUSIONS:Twice-daily dosing of FP is more effective than once-daily dosing, although the latter can maintain asthma control in most patients.

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