scholarly journals The contribution of galenics to patients’ sensory perception of nasal sprays after nasal surgery – data from a prospective randomized, controlled, double-blind, cross-over, multi-centre study

2021 ◽  
Author(s):  
Christoph Bergmann ◽  
Jennifer Lander ◽  
Lea Radtke ◽  
Laura England ◽  
Jaswinder Singh ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Nasal Surgery ◽  
Double Blind ◽  
Multi Centre Study ◽  
Entire Study ◽  
Nasal Sprays ◽  
Periodic Effect ◽  
Physical Examinations ◽  
Sum Scores ◽  
The Eu

Abstract Introduction:Postoperative care after nasal surgery is commonly achieved with nasal sprays. The current study compared two decongesting, wound healing nasal sprays in patients after nasal surgery in order to investigate their sensoric perception. One of the sprays presented a new galenic formulation (nasic® neo, Cassella-med GmbH & Co. KG).Methods:Using a cross-over design, patients who had undergone nasal surgery applied two different nasal sprays during two treatment periods of 4 days each, interrupted by 3 days wash out period. Sensoric perception of the nasal sprays was assessed with the nasal-spray-sensoric-scale. Throughout the study, nasal obstruction was evaluated by patients, and physical examinations, measurements of vital parameters and rhinoscopic examinations were carried out by investigators. Adverse events were documented during the entire study, and following treatment, patients judged the overall preference, efficacy and tolerability of both products.Results:Overall, no significant differences in sum scores of the assessments of the nasal-spray-sensoric-scale were observed between treatments. Significant periodic effect observed during the cross-over study limited the overall analysis. Nevertheless, it could be shown that significantly more patients preferred the new galenics nasal spray compared to the comparator spray (57.1% vs. 34.7%; p=0.031). Further, 10% more patients rated the efficacy of new galenics as ‘good’ to ‘very good’ compared to the comparator. Importantly, a subgroup population of patients with more pronounced signs of inflammation present at screening evaluated the sensoric perception of new galenics significantly better (p=0.033) compared to the comparator. Within this subgroup, no periodic effect was observed. The application of both nasal sprays was shown to be safe and well-tolerated.Conclusion:The current study showed that the overall sensoric perception of both nasal sprays was evaluated comparably well in patients after nasal surgery and that overall, the application of the new galenics nasal spray was preferred by significantly more patients compared to the comparator nasal spray. Patients with marked nasal abnormalities may have a greater benefit from the contribution of galenics as significant differences in the sensoric evaluation by the nasal-spray-sensoric-scale in favour of the new galenics product were shown for this subgroup.Trial registration: The current study was registered in the EU Clinical Trials Register with the EudraCT No: 2019-004936-52.

scholarly journals COVID-19: Azelastine nasal spray Reduces Virus-load In Nasal swabs (CARVIN). Early intervention with azelastine nasal sprays reduces viral load in SARS-CoV-2 infected patients. First report on a double-blind placebo-controlled phase II clinical trial.

2021 ◽  
Author(s):  
Jens Peter Klussmann ◽  
Clara Lehmann ◽  
Maria Grosheva ◽  
Kurtulus Sahin ◽  
Eszter Nagy ◽  
...  
Keyword(s):  
Viral Load ◽  
Nasal Spray ◽  
Load Reduction ◽  
Double Blind ◽  
Double Blind Placebo ◽  
E Gene ◽  
Nasal Sprays ◽  
Viral Loads ◽  
Viral Load Reduction ◽  
Subgroup Analyses

Abstract Background:The current COVID-19 pandemic has had a major influence on our daily lives. The most frequent early symptoms associated with SARS-CoV-2 infection are coughing, fever, rhinitis, and loss of smell and taste. If the infection progresses to the lower respiratory tract, it can cause massive inflammation of the pulmonary system, which can be life threatening. There is urgent need for a broadly available and effective therapy for the treatment of early infections with SARS-CoV-2 in order to prevent progression to severe disease. Methodology:CARVIN is a phase II proof of concept, randomized, parallel, double-blind, placebo-controlled, interventional clinical trial. 90 SARS-CoV-2 positive volunteers were randomized into three groups to receive either placebo, azelastine 0.02% or azelastine 0.1% nasal spray for a period of 11 days. Seven nasopharyngeal swabs were taken during this period for quantitative PCR measurements assessing the viral load via the ORF 1a/b and E genes. Investigators also assessed patients’ status continuously throughout the trial, and the intensity of individual symptoms were reported by the patients using an electronic diary. Two safety follow-ups were performed at days 16 and 60 of study participation. Results:Since the data of the primary outcome did not show a normal distribution, all statistical tests presented here were done non-parametrically and all p-values are descriptive and without adjustment for multiple testing. A broader descriptive analysis will be performed at a later date on all variables and it will be published in a peer-reviewed publication. A wide range of initial viral loads in the nasopharyngeal swabs of the study population was observed with an overall median/mean + SD Ct value of approximately 21.9 / 23.6 + 5.8, corresponding to log10 6.6 + 1.8 copies per /ml. Out of the 90 enrolled subjects, at least 54 carried the Alpha (B.1.1.7, UK) variant.Treatment with azelastine nasal sprays resulted in a greater but non-significant decrease in mean viral load compared to that measured in the placebo group at all 6 timepoints after initiation of treatment. This tendency was stable and most pronounced on day 8 (after 7 days treatment), when in the 0.1% and 0.02% azelastine nasal spray groups, an approximately 8- and 29-fold greater clinically meaningful reduction of the baseline viral load, respectively, compared to placebo was observed (based on the ORF1a/b gene). On days 4 and 11, approximately 4-fold greater mean viral load reduction was seen in the 0.1% azelastine group.Differences in mean viral load compared to baseline values were seen starting on the second day (after one day of treatment) in the azelastine 0.1% and azelastine 0.02% group for ORF 1a/b gene, and with azelastine 0.1% for the E gene, while this reduction was less pronounced in the placebo group.The effects of 0.1% azelastine nasal spray treatment to accelerate viral load reduction were even more pronounced in patients with initial high viral load (subgroup analyses in patients exhibiting initial Ct values below 25 and below 20, respectively). Of note, by day 8 the PCR-test had turned negative in more patients in the 0.1% azelastine group (n=6, p= 0.01 for the ORF 1a/b gene and n = 3, p= 0.08 for the E gene) and in the 0.02% azelastine group (n=8, p< 0.01 for the ORF 1a/b gene and n = 5, p= 0.02 for the E gene) than in the placebo group (n=0 for the ORF 1a/b gene and n = 0, for the E gene).Discussion:This study provides the first clinical hints of the effects of an azelastine nasal spray in SARS-CoV-2 positive patients. Subgroup analyses performed in patients exhibiting high initial viral loads are further suggestive of azelastine’s potential as an antiviral treatment.

scholarly journals Iota-carrageenan and xylitol inhibit SARS-CoV-2 in Vero cell culture

PLoS ONE ◽  
2021 ◽  
Vol 16 (11) ◽  
pp. e0259943
Author(s):  
Shruti Bansal ◽  
Colleen B. Jonsson ◽  
Shannon L. Taylor ◽  
Juan Manuel Figueroa ◽  
Andrea Vanesa Dugour ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Unmet Need ◽  
Preliminary Finding ◽  
Controlled Study ◽  
Antiviral Action ◽  
Double Blind ◽  
Nasal Sprays ◽  
Global Pandemic ◽  
Effective Option

Last year observed a global pandemic caused by SARS-CoV-2 (severe acute respiratory syndrome-coronavirus 2) infection affecting millions of individuals worldwide. There is an urgent unmet need to provide an easily producible and affordable medicine to prevent transmission and provide early treatment for this disease. Since the nasal cavity and the rhinopharynx are the sites of initial replication of SARS-CoV-2, a nasal spray may be an effective option to target SARS-CoV-2 infection. In this study, we tested the antiviral action of three candidate nasal spray formulations against SARS-CoV-2 in vitro. We determined that iota-carrageenan in concentrations as low as 6 μg/mL inhibits SARS-CoV-2 in vitro. The concentrations of iota-carrageenan with activity against SARS-CoV-2 in vitro may be easily achieved through the application of nasal sprays as commonly used in several countries. Recently a double-blind, placebo-controlled study showed that iota-carrageenan in isotonic sodium chloride reduces ca. five times the risk of infection by SARS-CoV-2 in health care personnel. Further, xylitol at a concentration of 50 mg/mL (ca. 329 mM) was found to exert some antiviral action, though this preliminary finding needs further confirmation.

scholarly journals Effectiveness of ovarian suspension in preventing postoperative ovarian adhesions in patients with severe pelvic endometriosis—a case-control study

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Zahra Dehbashi ◽  
Shaheen Khazali ◽  
Fateme Davari Tanha ◽  
Farnaz Mottahedian ◽  
Mahsa Ghajarzadeh ◽  
...  
Keyword(s):  
Pregnancy Rate ◽  
Transvaginal Ultrasound ◽  
Stage Iv ◽  
Clinical Pregnancy ◽  
Reproductive Age ◽  
Deep Infiltrating Endometriosis ◽  
Pelvic Endometriosis ◽  
Double Blind ◽  
Entire Study

Abstract Background Endometriosis can exert obvious negative effects on women’s quality of life. Excisional surgery is among the most effective treatments for severe pelvic endometriosis. The prevalence of severe pelvic adhesions following a laparoscopic examination of severe endometriosis varies between 50 and 100%. Temporary intraoperative ovarian suspension is a method for the reduction of adhesions is in the treatment of severe pelvic endometriosis. Given the importance and the prevalence of endometriosis and its complications, we conducted the present study to determine more effective adhesion-reducing methods with a view to improving the quality of the treatments provided. Methods The present prospective double-blind randomized clinical trial was conducted on 50 women of reproductive age (≥ 19 years) diagnosed with severe pelvic endometriosis on transvaginal ultrasound scans and vaginal examinations at Yas Hospital between 2014 and 2017. Women with severe endometriosis (stage III, stage IV, and deep infiltrating endometriosis) requiring an extensive bilateral dissection of the pelvic walls and the rectovaginal space, with preserved uterus and ovaries, were included in the study. The preoperative severity of ovarian adhesions was assessed in terms of ovarian motility, measured through a combination of gentle pressures applied with the vaginal probe and abdominal pressures applied with the examiner’s free hand. A table of random numbers was used to choose which ovary to suspend. The entire study population received standard general anesthesia. In the laparoscopic examination of the cases with severe endometriosis, both ovaries were routinely suspended to the anterior abdominal wall with PROLENE sutures. At the end of the surgery, one of the ovaries was kept suspended for 7 days, whereas the other ovarian suspension suture was cut. At 3 months postoperatively, all the patients underwent ultrasound scans for the assessment of ovarian motility and adhesions. The severity of pelvic pain was defined according to a visual analog score. After surgery, infertile women were followed for 2-4 years, and were contacted regarding the infertility treatment. Chemical and clinical pregnancy rates was compered between the two groups. Results Three months after laparoscopy, the adhesions were mild in 41 (82%) patients and moderate in 9 (18%) on the suspended side, and mild in 12 (24%) patients and moderate in 38 (76%) on the control side (P < 0.001). The mean dysmenorrhea score was 6.8 ± 1.5 before surgery and 4.5 ± 1.4 after surgery (P < 0.001). The chemical pregnancy rate and clinical pregnancy rate were not different in the suspended and control groups (P = 0. 62, P = 0.64). Conclusions The reduction in adhesions via ovarian suspension surgery promises reductions in the complications of endometriosis.

Bioabsorbable dressing impregnated with betamethasone and ciprofloxacin after endoscopic sinus surgery: A randomized, double-blind, placebo-controlled study

2021 ◽  
pp. 014556132110624
Author(s):  
Małgorzata Wierzchowska ◽  
Paulina Kalińczak-Górna ◽  
Błażej Grześkowiak ◽  
Kamil Radajewski ◽  
Jakub Burduk ◽  
...  
Keyword(s):  
Endoscopic Sinus Surgery ◽  
Healing Process ◽  
Nasal Packing ◽  
Sinus Surgery ◽  
Controlled Study ◽  
Nasal Surgery ◽  
Double Blind ◽  
Nasal Blockage ◽  
Positive Effects ◽  
Mucosal Edema

Background In addition to its hemostatic and stabilization role, biodegradable nasal packing can be used as a carrier for drugs after functional endoscopic sinus surgery (FESS). The aim of this study was to compare the influence of biodegradable synthetic polyurethane foam (NasoPore) soaked with ciprofloxacin, or betamethasone, or both to the same foam soaked with saline after FESS. Methods 120 adults with chronic rhinosinusitis, with and without polyps, directed for bilateral full-house FESS were enrolled for the study. The patients were randomized and blinded into 3 groups, depending on the type of postoperative procedure applied. Thus, NasoPore soaked with antibiotic was provided to the first group; in the second group, the steroid was used; and the combination of both, in the third group. In each case, the aforementioned procedure was administered on one side of the nose, while NasoPore was soaked in saline on the other, at the end of the surgery, respectively. The patients were requested to complete a questionnaire during their postoperative visits at 2, 10, 30, 90, and 180 days, scoring the level of complaints on the VAS scale, separately for each side. The evaluation of the healing process was performed at each visit using rigid endoscopy and subsequently rated on numerical scales. Results Decreased mucosal edema and secretion; reduced Lund-Kennedy score; and favorable influences on facial pressure, nasal blockage, and smell were most evidently seen in the group receiving the antibioticsteroid combination. Conclusions The application of biodegradable nasal packing with betamethasone and ciprofloxacin in sino-nasal surgery has positive effects not only on the healing process but also impacts patient’s comfort. To optimize it, however, further research is needed.

Sex Dependent Association of Vitamin D with Insulin Resistance

2021 ◽  
Author(s):  
Xin Chen ◽  
Chang Chu ◽  
Cornelia Doebis ◽  
Volker von Baehr ◽  
Berthold Hocher
Keyword(s):  
Insulin Resistance ◽  
Vitamin D ◽  
Vitamin D Deficiency ◽  
Animal Studies ◽  
Linear Regression Analysis ◽  
Cross Sectional Study ◽  
Multivariate Linear Regression Analysis ◽  
Double Blind ◽  
Cross Sectional ◽  
Entire Study

Abstract Background Animal studies suggested that vitamin D might decrease insulin resistance. Estrogen increased insulin sensitivity and glucose tolerance in rodents. However, sex-specific association of vitamin D with insulin resistance in humans remains unclear. Objectives To investigate the sex-dependency of the association of insulin resistance and 25(OH)D in a large Caucasian population. Methods Cross-sectional study from out-patients’ blood samples with measurements of 25(OH)D and HOMA-IR drawn at exactly the same day (N=1887). This cohort was divided into three groups: i) group with vitamin D deficiency (n=1190), ii) group with vitamin D sufficiency (N=686)), iii) vitamin D excess groups (n=11), the vitamin D excess group was excluded from further analysis due to the small size. Results Analysis of the entire study population showed that serum 25-hydroxyvitamin D was inversely associated with HOMA-IR (rs=-0.19, P&lt;0.0001). When considering the vitamin D status, this association was only seen in the vitamin D deficiency group, but not in the vitamin D sufficient group. The correlation was sex-dependent: HOMA-IR was inversely correlated with vitamin D in women with vitamin D deficiency (rs=-0.26, P&lt;0.0001) but not in men with vitamin D deficiency (rs=0.01, P=0.714). After multivariate linear regression analysis considering confounding factors, this relationship was again only seen in women. Conclusion Vitamin D was inversely and independently associated with insulin resistance only in women with vitamin D deficiency. Based on our data, we suggest that in particular vitamin D deficient women might benefit from vitamin D substitution by improving insulin resistance. This, however, needs to be proven in adequately designed double-blind placebo-controlled clinical studies.

scholarly journals A Patient Preference Study that Evaluated Fluticasone Furoate and Mometasone Furoate Nasal Sprays for Allergic Rhinitis

2016 ◽  
Vol 7 (4) ◽  
pp. ar.2016.7.0185 ◽  
Author(s):  
Anahi Yanez ◽  
Alex Dimitroff ◽  
Peter Bremner ◽  
Chae-Seo Rhee ◽  
Graham Luscombe ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Patient Preference ◽  
Patient Adherence ◽  
Sensory Attributes ◽  
Mometasone Furoate ◽  
Study Patient ◽  
Fluticasone Furoate ◽  
Nasal Sprays ◽  
Nasal Irritation

Background Corticosteroid nasal sprays are the mainstay of treatment for allergic rhinitis. These sprays have sensory attributes such as scent and/or odor, taste and aftertaste, and run down the throat and/or the nose, which, when unpleasant, can affect patient preference for, and compliance with, treatment. Objective This study examined patient preference for fluticasone furoate nasal spray (FFNS) or mometasone furoate nasal spray (MFNS) based on their sensory attributes after administration in patients with allergic rhinitis. Methods This was a multicenter, randomized, double-blind, cross-over study. Patient preferences were determined by using three questionnaires (Overall Preference, Immediate Attributes, and Delayed Attributes). Results Overall, 56% of patients stated a preference for FFNS versus 32% for MFNS (p < 0.001); the remaining 12% stated no preference. More patients stated a preference for FFNS versus MFNS for the attributes of “less drip down the throat” (p < 0.001), “less run out of the nose” (p < 0.05), “more soothing” (p < 0.05), and “less irritating” (p < 0.001). More patients responded in favor of FFNS versus MFNS for the immediate attributes, “run down the throat” (p < 0.001), and “run out of the nose” (p < 0.001), and, in the delayed attributes, “run down the throat” (p < 0.001), “run out of the nose” (p < 0.01), “presence of aftertaste” (p < 0.01), and “no nasal irritation” (p < 0.001). Conclusion Patients with allergic rhinitis preferred FFNS versus MFNS overall and based on a number of individual attributes, including “less drip down the throat,” “less run out of the nose,” and “less irritating.” Greater preference may improve patient adherence and thereby improve symptom management of the patient's allergic rhinitis.

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