fusafungin and Rhinitis

In a monocenter, placebo-controlled, double-blind, parallel-group study, 20 patients with acute symptoms of rhinosinusitis were treated with either fusafungine (CAS 1393-87-9, Locabiosol Dosier-Spray) (n = 10) or placebo nasal spray (n = 10). One patient from the placebo group was withdrawn from the study on the day of inclusion for noncompliance reasons. At the beginning of the 2-week treatment period, absence of an acute exacerbation of sinusitis with, e.g., opacity or fluid in any of the sinuses, was documented by computed tomography. Efficacy of treatment was assessed using objective measurements (e.g. sonography, rhinomanometry, acoustic rhinometry, and endoscopy) as well as scores recorded by the investigator on 6 consecutive visits before and after 1, 3, 7, 10, and 14 days of treatment, and by the patients on a diary card. Drug safety was evaluated on the basis of twice-daily assessment of general well-being and side effects. Statistical analysis of the data evidenced a positive effect of fusafungine as early as by the first 24 h of treatment (reduction of symptom score D0-->D1: p < 0.01), which was not seen in the placebo group (p = 0.2174). In the final assessment, both investigator and patients rated global efficacy better with fusafungine. In some instances, the intergroup difference achieved statistical significance (patient diaries, p = 0.0342). Side effects such as reactions at the application site mainly occurred in patients in the placebo group, who rated tolerability markedly worse than patients taking fusafungine (p = 0.0304; patient diaries, p = 0.0170).

Topics: Administration, Inhalation; Administration, Topical; Adult; Aerosols; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Depsipeptides; Double-Blind Method; Female; Fusarium; Humans; Male; Rhinitis; Rhinometry, Acoustic; Sinusitis; Ultrasonography

The aim of the study was to estimate by means of acoustic rhinometry (AR) the nasal blockade in 37 patients (5-73 years old, mean 32) with upper airways infections treated by fusafungine. The examinations were carried out on the first (D1) and seventh day (D7) of observation. Cross-sectional area (CA) mean values of 3 cm sector laid back to C notch of AR curves (CA-C3) were selected to the analysis.. The mean value of CA-C3: in all patients it was 2.61 cm2 on D1 and 2.8 cm2 on D7; in rhinitis and sinusitis patients--2.23 cm2, in others--3.16 cm2; without nasal discharge--3.48 cm2, in others (with severe or medium)--2.53 cm2 and 2.48 cm2 respectively. 29 patients had nasal blockade (78.4%) with mean CA-C3 = 2.34 cm2 (others--3.56, p < 0.05). During seven days the following enlargement of CA-C3 was reported: 14.9% in all patients (p < 0.01); in viral infections 24% (n = 14, p < 0.01), bacterial 14.3% (n = 11, NI); in nasal blockade patients--15.22%, others--13.55% (p < 0.01). Mean value of CA-C3 increased by 37.7% in patients who demonstrated, according to the physicians, "very good improvement", 5.7%--"good", 1.5%--"weak" (p < 0.05). There was also enlargement of nasal cavities in CA-C3 in non-sneezers (p < 0.05) and medium discharge symptom patients (p < 0.05). There was no statistical difference in clinical and acoustic rhinometry results between patients treated with fusafungine together with non-steroid anti-inflammatory drugs and patients treated with fusafungine.. AR is a good instrument to be used in the objective assessment of the nasal blockade changes in people with infection of the nasal mucosa and showed positive efficacy of fusafungine in the treatment of upper airway infection.

Topics: Acoustics; Adolescent; Adult; Aerosols; Aged; Anti-Bacterial Agents; Child; Child, Preschool; Depsipeptides; Female; Fusarium; Humans; Male; Middle Aged; Nasal Obstruction; Paranasal Sinuses; Respiratory Tract Infections; Rhinitis; Sinusitis

An open, randomized, comparative trial of the drug bioparox was made in 50 patients. Nasal cavity function and its changes in response to bioparox administration were studied with the saccharin test and measurement of ciliary motor activity (CMA) using a special computer program. Significant suppression of the transport function and CMA in all the patients with catarrhal rhinosinusitis was observed. SMA on the inferior turbinated bone and septum was minimal, being low on the middle turbinated bone. After 7 days of bioparox administration mean value of CMA rose 2-fold. Thus, it is demonstrated that bioparox inhalations have no negative effect on nasal ciliated epithelium. On the contrary, it enhances its recovery.

Topics: Acute Disease; Adolescent; Adult; Aged; Anti-Bacterial Agents; Depsipeptides; Female; Fusarium; Humans; Male; Middle Aged; Nasal Mucosa; Rhinitis; Sinusitis

The short-term effects of local intranasal administration of fusafungine were studied for its anti-inflammatory and antimicrobial properties against experimentally induced bacterial rhinosinusitis. The maxillary sinuses of 20 rabbits were infected with encapsulated Streptococcus pneumoniae after mechanical occlusion of each animal's anatomic ostium. Either fusafungine solution or placebo was administered as a nasal spray through the nostrils twice daily for 10 days. Histopathological grading of inflammation, biochemical assay of inflammatory mediators, and the number of bacterial species isolated from the nasal cavities all showed significant recovery from inflammation after fusafungine treatment. The beneficial effects of fusafungine on inflamed sinus mucosa may possibly also be attributable to an initial alleviation of inflammation in the nasal cavity, which permitted entry of the drug to the sinus cavity through a partially reopened ostium. A reciprocal relationship between nasal and sinus reactivity involving generalization of inflammation and recovery was also thought to be of importance. The present findings indicate that local applications of fusafungine may effectively improve clinical conditions producing rhinitis and sinusitis.

Topics: Administration, Intranasal; Aerosols; Animals; Anti-Bacterial Agents; Depsipeptides; Disease Models, Animal; Female; Fusarium; Male; Maxillary Sinusitis; Nasal Mucosa; Pneumococcal Infections; Rabbits; Rhinitis

We measured with a laser velocimeter granulometric deposit of an aerosol anti-infectious agent, fusafungin, administered with a controlled inhalator. Total drug deposit was determined on the basis of a granulometric spectrum of the polydispered aerosol (mass mean aerodynamic diameter (MMAD) = 2.8 +/- 1.7 microns) and dispersion in the airways was estimated using the Stahlhofen model. We first compared deposits obtained with oral inhalation in 19 normal subjects and 20 patients with chronic obstructive lung disease. Total deposit in the airways of patients with chronic obstructive lung disease (82%) was not significantly different from that in normal subjects (85%). Estimated dispersion in normal airways was 27% in the alveoles, 8.4% in the tracheobronchic region and 23.5% in the extrathoracic regions. We then compared deposits after nasal inhalation in 22 normal subjects and 21 patients with rhinitis: nasal deposit was significantly greater in patients with rhinitis (54.5%) than in controls (44.7%). We conclude that such an inhalator can be adapted for local treatment of ENT infections and upper respiratory infections. Deposit is not modified in case of obstructive bronchopathy.

Topics: Adult; Aerosols; Anti-Bacterial Agents; Depsipeptides; Fusarium; Humans; Lung Diseases, Obstructive; Middle Aged; Models, Biological; Nose; Particle Size; Research; Rheology; Rhinitis

An open clinical trial of Locabiotal, in which the antibiotic, fusafungine, is presented in a micronized aerosol was performed in general practice. One hundred and ten patients suffering from upper respiratory infections without associated hyperpyrexia or toxic symptoms were treated for 7 days. There was a marked improvement in the symptoms rated during the first 48 hours. After the full course of treatment 37 patients regarded its effect as excellent and 48 as good.

Topics: Adolescent; Adult; Aerosols; Aged; Anti-Bacterial Agents; Child; Child, Preschool; Common Cold; Depsipeptides; Female; Humans; Laryngitis; Male; Middle Aged; Pharyngitis; Respiratory Tract Infections; Rhinitis