Cientificamente endossado

O sistema NasoNeb® administra o medicamento ou soro fisiológico profunda e penetrantemente no seio e nas cavidades dos seios paranasais, sem o risco de complicações decorrentes de outros sistemas de liberação de medicamentos.

The NasoNeb® System delivers a deep, penetrating aerosol to the nasal and paranasal sinus cavities with virtually no incidental pulmonary delivery of drugs and the risk of resultant complications common with small particle nebulizers.

Two university based outcomes trials demonstrated positive clinical evidence. NasoNeb-delivered budesonide, (Pulmicort Respules® 0.25 mg/2ml), demonstrated statistically-significant objective and subjective outcomes in a peer-reviewed clinical study. 9 NasoNeb-delivered levofloxacin demonstrated a statistically-significant reduction in total bacterial abundance in a peer-reviewed clinical study.

NasoNeb-delivered budesonide (Pulmicort Respules®, 0.25 mg/2ml) demonstrated a statistically-significant 50 LPM increase in daily nasal peak inspiratory flow (NPIF) from baseline to endpoint in the treatment arm of a parallel, randomized, double-blinded, placebo controlled clinical trial in a perennial allergic rhinitis patient population.

The authors concluded, in part: "it stands to reason that administering intranasal corticosteroids, which have been shown effective time and again as a treatment for perennial allergic rhinitis, would prove to be even more effective when delivered in this novel way." Daily nasal peak inspiratory flow on treatment. Median values are depicted. The x-axis shows the study timeline with B = baseline measurement. *p < 0.005 vs baseline for the group on budesonide

Patients also reported statistically-significant improvements in total nasal symptoms scores (TNSS) and rhinoconjunctivitis quality of life scores.

Daily TNSS on treatment. Median values are depicted. The x-axis shows the study timeline with B = baseline measurement. *p < 0.05 vs respective baselines within treatment groups.

The broad deposition, high intranasal drug retention and no pulmonary deposition of the NasoNeb Sinus Therapy System makes it the best choice for intranasal drug delivery, as demonstrated by positive outcomes data.

NasoNeb delivers up to 71 times more medication

Other technologies deliver only 3-10% of the drug to the nasal and paranasal sinus cavities.

  • The patented NasoNeb® System has been clinically-shown to deposit a low volume, high concentration of medication to the nasal and paranasal sinus cavities.
    • Studies, including two peer-reviewed journal articles, demonstrate that the NasoNeb System deposits medication to the nasal and paranasal sinus cavities, including the frontal recess/sinus, spheno-ethmoid recess, ethmoid cavity, sphenoid and maxillary sinuses, all turbinates, the middle meatus and olfactory cleft.
    • In “The effects of middle turbinate resection on topical drug distribution into the paranasal sinuses” 4, the authors stated “The fact that it (NasoNeb-delivered medication) does not appear to immediately rinse out in the way saline irrigations do could suggest an improved delivery of medication directly to the mucosa.” And “…the mucosal staining from the nebulized dye was far more intense and therefore more reliably observed than the mucosal staining from dye delivered via a rinse bottle”.
  • This deposition pattern matters.
    • In a randomized, placebo-controlled study of the response of a population of allergic rhinitis sufferers, NasoNeb-delivered budesonide (Pulmicort Respules, 0.25 mg/2.5 ml) demonstrated a statistically-significant, 50 LPM increase in daily peak inspiratory flow from baseline to endpoint in the treatment arm on day 3, which persisted to the end of the study. Furthermore, quality of life and total nasal symptom scores also showed statistically-significant improvements from baseline to endpoint.
    • NasoNeb-delivered Levofloxacin demonstrate a reduction in total bacterial abundance in a randomized, controlled trial of chronic sinusitis patients.
    • A peer reviewed study of an ovine (sheep) model of hydrocephalus demonstrated a statistically-significant increase in cerebrospinal fluid absorption by 2.29 and 2.44 fold using 2 different active agents, indicating the ability of NasoNeb to deliver medications intended to be absorbed via the nasal mucosal membrane.
    • In a retrospective, 4-year analysis of 64 patients in one clinical practice who had undergone surgery for nasal polyps, NasoNeb-delivered corticosteroids demonstrated an 80% reduction in repeat polyp surgeries and a 12.5% risk reduction for revision surgery in the NasoNeb group compared to the non-NasoNeb group.
  • The FDA guidance document on nasal drug delivery states “Particles or droplets that are aerodynamically smaller than the standard 5 micron upper bound of the respirable fragment size can be inhaled. For nasal deposition, the optimal droplet or particle size should be, on the whole, substantially larger than the respirable fragment size”.

Table 1. Percentage of NasoNeb-generated particles by size, in microns

  • The NasoNeb System is the only large particle, low volume, high concentration delivery system available that is backed by clinical data.
    • Small particle nebulizers, often adapted pulmonary nebulizers, deliver a substantial fraction of the drug to the pulmonary system.
      • This can increase systemic bioavailability of the drug, leading to systemic side effects.
      • Studies have shown that only 3% of the drug reaches the intended nasal and paranasal sinus cavities when delivered by these devices.
    • Aerosol-generating powered nasal irrigators are sometimes prescribed off-label.
      • These devices are designed for saline irrigation and feature vents that capture spent fluid that is directed into a waste container for disposal by the user.
      • These vents enable airflow from the stream to be vented to the environment and directed away from the nose, reducing their ability to deposit fluid deep into the nasal and paranasal sinus cavities.
  • The NasoNeb System delivers large particles that are readily filtered by the nose to ensure a large percentage of medication is delivered where the physician intended and that no drug is delivered to the lungs, reducing the risk of unwanted complications.
    • These particles are delivered via a positive pressure airstream that ensures the medication reaches all of the nasal and paranasal sinus cavities.
  • The NasoNeb System delivers a low volume of liquid to ensure that the medication stays in the nasal cavity.
    • Unlike medicated irrigation solutions of which 97.2 – 98.6% or more run down the sink, the NasoNeb has the capacity to deliver between 0.2 – 15 ml of solution that is retained in the nasal and paranasal sinus cavities.
  • Many liquid medications require refrigeration to extend shelf life. Repeated exposure to cold fluid irrigation has been shown to cause a unique complication of exostoses of the paranasal sinus cavities in post-surgical patients.
    • Exostoses are bony formations under the mucosa and are commonly seen in the ear canals of cold-water swimmers and surfers.
    • The time to warm irrigation solution to near room temperature requires 120 minute wait period from the time the medication is removed from the refrigerator.
    • This waiting period may reduce patient compliance and increase the likelihood of repeat cold fluid exposure should the patient not wait to perform the irrigation.
    • In this instance, the use of medicated irrigations could violate the “do no harm” oath.
    • The aerosolizing action of the NasoNeb System warms refrigerated solutions to near room temperature immediately, which may help to avoid the iatrogenic complication of exostoses from cold fluid irrigation.

Table 2. Comparing Intranasal Drug Delivery Systems