SinuSurf vs. Saline Solution in Normal Subjects
Condition: Rhinosinusitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, prospective, placebo controlled trial of tolerability and safety of
      low-concentration SinuSurf sinus irrigation solution in normal subjects. Forty (40) healthy
      subjects aged 18-65 will be enrolled in the study.
    

Detailed description: 
      Rhinosinusitis, or sinusitis, is a bacterial or fungal infection in the sinuses that results
      from a build-up of mucus, which causes inflammation of the sinus cavities. NeilMed SinuSurf
      solution is a mucoactive surfactant designed to be added to NeilMed large-volume saline
      irrigation solution for the purpose of improving the clearance of mucus caused by sinusitis.
      In vitro studies have shown that topical surfactant therapies, such as SinuSurf, have been
      shown as an efficacious treatment of the inflammation of the sinuses (rhinosinusitis). In
      particular, these therapies have been shown to have antimicrobial effects, including a
      decrease in numbers of bacteria when used alone and an elimination of bacteria when combined
      with antibiotics. To date, initial safety studies of SinuSurf in an in-vitro model have
      confirmed a lack of toxicity to ciliary beat frequency and also a lack of toxicity in nasal
      explants model.

      In a comparative analysis of saline and surfactant irrigation in post-operational endoscopic
      endonasal surgery subjects, Farag, et al. found those receiving surfactant irrigation
      reported more side effects and 20% of subjects on the surfactant irrigation discontinued use
      compared to none receiving saline. Rohrer, et al. found that surfactants, when added to
      saline, cleared sinus spaces significantly better than saline alone.

      A previous version of SinuSurf was on the market from 2011-2012; however, it was removed from
      the market due to anecdotal reports of concerns regarding pain, dryness, and temporary
      alteration of sense of smell. While no reports of permanent alteration of sense of smell have
      been received, NeilMed wishes to assess the tolerability and safety of a revised,
      lower-concentration formulation of SinuSurf prior to re-introduction in the market. The
      purpose of this trial is to assess the tolerability and potential side effect profile,
      specifically alterations to the sense of smell, of a revised, low-concentration sinus
      irrigation solution in a population of normal subjects.

      Healthy participants are included in this study because SinuSurf™ is an over-the-counter
      (OTC) product used for symptoms rather than one particular disease, just as are saline
      rinses. It is an over-the-counter product. One of the main outcome measures is the impact
      upon the sense of smell, which is already often compromised in patients with chronic
      nasal/sinus disease. Thus we seek to study it in patients with normal smell who also don't
      have other conditions that may impact sense of smell, which would potentially confound data
      interpretation. The dose/concentration is under patent, but involves one squirt of the
      "shampoo" into 240 cc of buffered nasal saline. There is anecdotal (internet) report that
      patients may have temporary smell loss with and that will be criteria for patient withdrawal
      and possibly early study termination.

      The advice that SinuSurf™ not be used more than 5 days is in order to prevent patients with
      medical conditions that should be evaluated by physician from deferring medical advice. These
      warnings are typical of over the counter products. In the present study, the product will be
      used under the physician's oversight. The 7 days period is chosen because it is a full "week"
      and is conceivably a time interval over which one would expect any changes in outcome
      measures from baseline.
    

Intervention name(s): SinuSurf irrigation twice daily; NeilMed Sinus rinse irrigation twice daily
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment