EFFICACY OF ALBUTEROL IN THE MANAGEMENT OF BRONCHIOLITIS

PEDIATRICS ◽  
1995 ◽  
Vol 96 (2) ◽  
pp. 397-398
Author(s):  
Napoleon Lee ◽  
Brett Kettelhut ◽  
Roger H. Kobayashi
Keyword(s):  
Heart Rate ◽  
Previous Treatment ◽  
Controlled Study ◽  
First Episode ◽  
Double Blind ◽  
Treatment Groups ◽  
Admission Rates ◽  
History Of ◽  
Group 2 ◽  
Syncytial Virus

Purpose of the Study. To determine the efficacy and safety of albuterol (0.15 mg/kg per dose) in the management of bronchiolitis. Study Population. Eighty-eight infants (mean age, 5.5 months old) with their first episode of wheezing due to bronchiolitis were enrolled. Exclusionary criteria included previous treatment with bronchodilators, mechanical ventilation, or a history of cardiorespiratory diseases. Methods. This was a double-blind, placebo-controlled study with infants randomly assigned into four treatment groups: 1) those who received nebulized albuterol (0.15 mg/kg) 2) those who received oral albuterol, 3) those who received nebulized placebo, and 4) those who received oral placebo. Patients were assessed at baseline, 30 minutes, and 60 minutes after treatment for respiratory rate (RR), symptom score (SC), heart rate (HR), and pulse oximeter (SPO2). Seventy-five had nasopharyngeal aspirate cultures perfomed. Results. Thirty-six (48%) of nasopharyngeal aspirates were positive for respiratory syncytial virus (RSV) and were equally distributed among the four groups. Four others had cultures positive for other viruses. HR, RR, SC, and SPO2 did not differ after 30 minutes and 60 minutes from initial treatment for groups 1, 3, and 4. Results were similar for group 2 except for an increase in heart rate (+15 beats/min) at 60 minutes (P = .006). Hospital admission rates were similar for all four groups. Reviewer's Comments. Albuterol in either form did not alter the course of bronchiolitis in infants. Care in selection of study infants was taken to identify those infants with wheezing due to a viral bronchiolitis and exclude other causes of wheezing.

scholarly journals A Combination of Lactoplantibacillus plantarum Strains CECT7527, CECT7528 and CECT7529 Plus Monacolin K Reduces Blood Cholesterol: Results from a Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1206
Author(s):  
Rafael Guerrero-Bonmatty ◽  
Guadalupe Gil-Fernández ◽  
Francisco José Rodríguez-Velasco ◽  
Jordi Espadaler-Mazo
Keyword(s):  
Intervention Group ◽  
Study Groups ◽  
Statin Treatment ◽  
Blood Cholesterol ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Red Yeast Rice ◽  
Monacolin K ◽  
Double Blind ◽  
History Of

Background: Dietary supplements have been proposed to help manage blood cholesterol, including red yeast rice (RYR) extracts, plant sterols and stanols, beta-glucans, and some probiotics. This study was conducted to evaluate the efficacy of RYR (containing 10 mg of monacolin K) combined with 109 CFU of three Lactoplantibacillus plantarum strains (CECT7527, CECT7528, and CECT7529). Methods: A 12-week randomized, double-blinded, placebo-controlled clinical trial was conducted. In total, 39 adult patients were enrolled, having total cholesterol (TC) ≥200 mg/dL, and being statin-naïve or having recently stopped statin treatment because of intolerance. Active product or placebo were taken once daily, and subjects were evaluated at baseline, 6, and 12 weeks. Results: Study groups were comparable at baseline, except for history of recent hypercholesterolemia treatment (81% in active vs. 22% in placebo). Changes in LDL cholesterol and TC became significant compared to placebo (mean difference between groups and standard error of the mean = 23.6 ± 1.5 mg/dL, p = 0.023 and 31.4 ± 1.9 mg/dL, p = 0.011, respectively) upon adjusting for the baseline imbalance in hypercholesterolemia treatment. No adverse effects were noted during the study. Conclusion: This combination of 10 mg of monacolin K and L. plantarum strains was well tolerated and achieved a statistically significant greater reduction in LDL-C and TC in the intervention group compared to the placebo, once adjusting for recent history of hypercholesterolemia treatment.

scholarly journals A randomized, double-blind, placebo-controlled study of an RNAi-based therapy directed against respiratory syncytial virus

2010 ◽  
Vol 107 (19) ◽  
pp. 8800-8805 ◽  
Author(s):  
J. DeVincenzo ◽  
R. Lambkin-Williams ◽  
T. Wilkinson ◽  
J. Cehelsky ◽  
S. Nochur ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Syncytial Virus

Safety and Efficacy of a Topical Anesthetic for Neonatal Circumcision

PEDIATRICS ◽  
1993 ◽  
Vol 92 (5) ◽  
pp. 710-714 ◽  
Author(s):  
Kathleen B. Weatherstone ◽  
Lynn B. Rasmussen ◽  
Allen Erenberg ◽  
Emily M. Jackson ◽  
Katherine S. Claflin ◽  
...  
Keyword(s):  
Vital Signs ◽  
Behavioral Changes ◽  
Controlled Study ◽  
Topical Anesthetic ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Exact Test ◽  
Treatment Groups ◽  
Topical Lidocaine ◽  
Postoperative Serum

Objective. Circumcision is a common neonatal surgical procedure routinely performed without the use of anesthesia. The purpose of this study was to evaluate the safety and efficacy of topical lidocaine cream as an anesthetic for circumcision. Methods. Thirty newborns were studied in a randomized, double-blind, placebo-controlled study; 15 received a topical 30% lidocaine cream and 15 received the cream base alone. Vital signs were recorded, and preoperative and postoperative serum β-endorphin and lidocaine concentrations were measured. A videotape of the newborn was used to score behavioral changes. Results. Comparisions of the vital signs precircumcision and postcircumcision showed no differences between the placebo and treatment groups, with the exception of mean systolic blood pressure, which significantly increased in the placebo-treated newborns (P < .05). Serum β-endorphin concentrations increased postoperatively in 11 of 15 subjects receiving placebo, but decreased or remained unchanged in 10 of 15 subjects receiving lidocaine (P = .03, Fisher's exact test). When stress-related behaviors in the precircumcision and post-circumcision periods were compared, the mean increase in their occurrence was greater in the placebo than in the treatment group. There was no significant absorption of lidocaine as measured in the serum. Conclusion. Topical application of a 30% lidocaine cream as used in this study may be a safe and efficacious anesthetic for circumcision.

scholarly journals Interaction of Cannabis Use Disorder and Striatal Connectivity in Antipsychotic Treatment Response

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Melanie Blair Thies ◽  
Pamela DeRosse ◽  
Deepak K Sarpal ◽  
Miklos Argyelan ◽  
Christina L Fales ◽  
...  
Keyword(s):  
Treatment Response ◽  
Reward Processing ◽  
Cannabis Use ◽  
First Episode ◽  
Antipsychotic Treatment ◽  
Cannabis Use Disorder ◽  
Schizophrenia Spectrum Disorders ◽  
Double Blind ◽  
History Of ◽  
The Relationship

Abstract Antipsychotic (AP) medications are the mainstay for the treatment of schizophrenia spectrum disorders (SSD), but their efficacy is unpredictable and widely variable. Substantial efforts have been made to identify prognostic biomarkers that can be used to guide optimal prescription strategies for individual patients. Striatal regions involved in salience and reward processing are disrupted as a result of both SSD and cannabis use, and research demonstrates that striatal circuitry may be integral to response to AP drugs. In the present study, we used functional magnetic resonance imaging (fMRI) to investigate the relationship between a history of cannabis use disorder (CUD) and a striatal connectivity index (SCI), a previously developed neural biomarker for AP treatment response in SSD. Patients were part of a 12-week randomized, double-blind controlled treatment study of AP drugs. A sample of 48 first-episode SSD patients with no more than 2 weeks of lifetime exposure to AP medications, underwent a resting-state fMRI scan pretreatment. Treatment response was defined a priori as a binary (response/nonresponse) variable, and a SCI was calculated in each patient. We examined whether there was an interaction between lifetime CUD history and the SCI in relation to treatment response. We found that CUD history moderated the relationship between SCI and treatment response, such that it had little predictive value in SSD patients with a CUD history. In sum, our findings highlight that biomarker development can be critically impacted by patient behaviors that influence neurobiology, such as a history of CUD.

Safety and Immunogenicity of the Ad26.RSV.preF Investigational Vaccine Coadministered With an Influenza Vaccine in Older Adults

2020 ◽  
Author(s):  
Jerald Sadoff ◽  
Els De Paepe ◽  
Wouter Haazen ◽  
Edmund Omoruyi ◽  
Arangassery R Bastian ◽  
...  
Keyword(s):  
Older Adults ◽  
Influenza Vaccine ◽  
Geometric Mean ◽  
Controlled Study ◽  
Tolerability Profile ◽  
Double Blind ◽  
Inhibition Antibody ◽  
Binding Antibody ◽  
Syncytial Virus ◽  
Significant Disease

Abstract Background Respiratory syncytial virus (RSV) and influenza cause significant disease burden in older adults. Overlapping RSV and influenza seasonality presents the opportunity to coadminister vaccines for both infections. This study assessed coadministration of the investigational vaccine, Ad26.RSV.preF, an adenovirus serotype 26 (Ad26) vector encoding RSV F protein stabilized in its prefusion conformation (pre-F), with a seasonal influenza vaccine in older adults. Methods In this phase 2a, double-blind, placebo-controlled study, 180 adults aged ≥60 years received Ad26.RSV.preF plus Fluarix on day 1 and placebo on day 29, or placebo plus Fluarix on day 1 and Ad26.RSV.preF on day 29 (control). Results The coadministration regimen had an acceptable tolerability profile. Reactogenicity was generally higher after Ad26.RSV.preF versus Fluarix, but symptoms were generally transient and mild or moderate. At 28 days after the first vaccination, the upper confidence intervals of the hemagglutination inhibition antibody geometric mean ratio (control/coadministration) for all influenza strains were <2, demonstrating noninferiority. Robust neutralizing and binding antibody responses to RSV A2 were observed in both groups. Conclusions Coadministration of Fluarix with Ad26.RSV.preF vaccine had an acceptable safety profile and showed no evidence of interference in immune response. The results are compatible with simultaneous seasonal vaccination with both vaccines. Clinical Trials Registration NCT03339713.

Effect of Evening Bromazepam Administration on Blood Pressure and Heart Rate in Mild Hypertensive Patients

Pharmacology ◽  
2019 ◽  
Vol 104 (1-2) ◽  
pp. 1-6
Author(s):  
Alfredo Costa ◽  
Daniele Bosone ◽  
Matteo Cotta Ramusino ◽  
Giulia Perini ◽  
Natascia Ghiotto ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Ambulatory Monitoring ◽  
Night Time ◽  
Double Blind ◽  
Hypertensive Patients ◽  
Treatment Groups ◽  
Significant Difference ◽  
Nocturnal Increase ◽  
Mild Hypertensive

Aim: To assess the effects of chronic evening oral administration of bromazepam alone or in combination with propranolol on ambulatory blood pressure (BP) and heart rate (HR) in mild hypertensive subjects. Methods: Thirty-seven mild hypertensive patients after a 2-week placebo period were randomized to bromazepam 3 mg, propranolol 40 mg, bromazepam 3 mg plus propranolol 40 mg or placebo for 2 weeks according to a double-blind, double dummy, cross-over design. After each treatment period, 24-h BP and HR ambulatory monitoring was performed by using a non-invasive device. Results: Ambulatory monitoring showed that during night-time SBP and DBP values were unaffected by bromazepam as compared to placebo, whereas SBP was significantly reduced by propranolol both when taken alone and in combination with bromazepam. HR nocturnal values were significantly reduced by propranolol, whereas they were significantly increased by bromazepan both when taken alone (+11.5%, p < 0.05 vs. placebo) and in combination with propranolol (+12.8%, p < 0.05 vs. propranolol). No significant difference in day-time values of SBP, DBP and HR was observed among the 4 treatment groups. Conclusions: In mild hypertensive patients, evening consumption of bromazepam for a 2-week period did not affect BP, while it increased nocturnal HR. Such an increase was observed both when bromazepam was taken alone and in combination with propranolol, which suggests that it depends on a bromazepam mediated decrease in vagal tone. Whatever the mechanism, the HR nocturnal increase might be of clinical relevance, due to the role of high HR as cardiovascular risk factor, particularly in already at risk hypertensive subjects.

scholarly journals Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study)

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Amy S. Paller ◽  
◽  
John Browning ◽  
Milos Nikolic ◽  
Christine Bodemer ◽  
...  
Keyword(s):  
Epidermolysis Bullosa ◽  
Wound Closure ◽  
Trial Registration ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Treatment Groups ◽  
Topical Cream ◽  
Link Type ◽  
Total Body

Abstract Background Epidermolysis bullosa (EB) is a rare genetic disorder that manifests as blistering and/or skin erosion. There is no approved treatment for EB; current standard of care consists of wound and pain management. SD-101 6% is a topical cream containing 6% allantoin that was developed for treating skin lesions in patients with EB. The aim of this phase 3, multicenter, randomized, double-blind, vehicle-controlled study was to assess the efficacy and safety of SD-101 6% cream versus vehicle (0% allantoin) on lesions in patients with EB. Methods Eligible patients were ≥1 month old, had a diagnosis of EB (simplex, recessive dystrophic, or intermediate junctional) and a target wound 10–50 cm2 in size that was present for ≥21 days. Patients were randomly assigned to SD-101 6% cream or vehicle, which was applied topically once a day to the entire body for 3 months. Primary efficacy endpoints were time to complete target wound closure within 3 months and the proportion of patients who experienced complete target wound closure within 3 months. Post hoc subgroup analyses were conducted by patient age and in those with body surface area index of total body wound burden ≥5% at baseline. Results In total, 169 patients were enrolled and randomly assigned to SD-101 6% (n = 82) or vehicle (n = 87). Baseline demographics and disease characteristics were similar between treatment groups. There were no statistically significant differences between treatment groups in time to target wound closure (hazard ratio, 1.004; 95% confidence interval [CI] 0.651, 1.549; P = 0.985) or proportion of patients with complete target wound closure within 3 months (odds ratio [95% CI], 0.733 [0.365, 1.474]; nominal P = 0.390). A positive trend toward faster wound closure with SD-101 6% versus vehicle was observed in patients aged 2 to <12 years and those with total body wound burden ≥5% at baseline. SD-101 6% cream was well tolerated. Conclusions SD-101 6% cream for treatment of EB-associated lesions was not more effective than vehicle in shortening the time to complete target wound closure or achieving complete target wound closure within 3 months. Trial registration ClinicalTrials.gov, NCT02384460; Date of trial registration, February 13, 2015; First participant enrolled, March 11, 2015.

Paroxetine in the Treatment of Panic Disorder a Randomised, Double-Blind, Placebo-Controlled Study

1995 ◽  
Vol 167 (3) ◽  
pp. 374-379 ◽  
Author(s):  
S. Oehrberg ◽  
P. E. Christiansen ◽  
K. Behnke ◽  
A. L. Borup ◽  
B. Severin ◽  
...  
Keyword(s):  
Panic Disorder ◽  
Cognitive Therapy ◽  
Panic Attacks ◽  
Controlled Study ◽  
Positive Trend ◽  
Double Blind ◽  
Treatment Groups ◽  
Efficacy Measures ◽  
The Mean ◽  
Primary Measure

BackgroundThis study compared the efficacy and tolerability of paroxetine with placebo in the treatment of panic disorder.MethodAfter three weeks of placebo, patients received 12 weeks of treatment with paroxetine (20, 40, or 60 mg) or placebo, and finally two weeks of placebo. Dosages were adjusted according to efficacy and tolerability. Standardised cognitive therapy was given to all patients. The primary measure of outcome was reduction in the number of panic attacks.ResultsAnalysis of the results showed statistically significant differences in favour of paroxetine between the two treatment groups in two out of the three primary measures of outcome, i.e. 50% reduction in total number of panic attacks and number of panic attacks reduced to one or zero over the study period. For the third measure of outcome, the mean change in the total number of attacks from baseline, there was a positive trend in favour of paroxetine. The results of the primary measures of outcome were strongly supported by the results of the secondary efficacy measures of outcome. In addition, paroxetine, at all doses, was very well tolerated.ConclusionParoxetine plus cognitive therapy was significantly more effective than placebo plus cognitive therapy in the treatment of panic disorder.

scholarly journals The Prophylactic Antiemetic Efficacy of Prochlorperazine and Ondansetron in Nasal Septal Surgery: A Randomized Double-Blind Comparison

1996 ◽  
Vol 24 (5) ◽  
pp. 538-545 ◽  
Author(s):  
A. A. Van Den Berg
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Cardiovascular Effects ◽  
Controlled Study ◽  
Postoperative Vomiting ◽  
Double Blind ◽  
Septal Surgery ◽  
Postoperative Headache ◽  
Per Se ◽  
Blind Comparison

A prospective, randomized placebo-controlled study was undertaken to compare the effects on heart rate and blood pressure during surgery and on the incidence of nausea, vomiting and headache after surgery of IM prochlorperazine 0.2 mg.kg-1, IV prochlorperazine 0.1 mg.kg-1 and IV ondansetron 0.06 mg.kg-1 given at induction of general anaesthesia to patients undergoing septorhinoplasty. The effects of the test drugs after administration on heart rate and blood pressure were similar, as were the incidences of retching and vomiting in the recovery ward after each test drug. Postoperatively, compared with placebo (7%), nausea per se was most frequent in those given IV prochlorperazine (25%, P<0.01), and less frequent in those given IM prochlorperazine (2%) and IV ondansetron (15%). Vomiting per se was reduced from 24% to 7% (P<0.025) by IV prochlorperazine and to 4% (P<0.0005) by IV ondansetron. The incidence of nausea with vomiting was reduced from 35% to 15% (P<0.025), 16% (P<0.05) and 11% (P<0.005) by IM prochlorperazine, IV prochlorperazine and IV ondansetron respectively. IM prochlorperazine and IV ondansetron increased the frequency (from 35% to 64%, P<0.0005 and to 71%, P<0.0005, respectively) of those experiencing no PONV and delayed the onset of PONV, but only IM prochlorperazine reduced the severity of postoperative vomiting. Headache was frequent in the control (69%), IV prochlorperazine (62%) and IV ondansetron (69%) groups, and least frequent after IM prochlorperazine (53%; P<0.05 versus IV ondansetron). It is concluded that these drugs have no adverse cardiovascular effects within 10 minutes of administration, IM prochlorperazine and IV ondansetron reduce PONV more effectively than IV prochlorperazine and postoperative headache after septorhinoplasty occurs less frequently in those given IM prochlorperazine than in those given IV ondansetron.

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