Comparative Study of Sinol and Sinol-M in Patients With Congestion Due to Allergic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the equivalence of two homeopathic capsaicin containing nasal sprays (Sinol-M™ and Sinol) in patients with nasal congestion due to allergic rhinitis.

Detailed Description
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Sinol is an FDA registered, capsaicin-based, over-the-counter homeopathic nasal spray used for the relief of allergy and sinus conditions. It is an all-natural product that the patient uses on an as-needed basis for up to 12 times daily. Sinol has been available in the US since 2004. In 2009 a second generation product, Sinol-M will be launched. Sinol-M is identical to the original formula but also contains MucoAd MucoAd™ is a patented non-toxic, non-irritating, liquid polymer mucoadhesive carrier that prolongs the contact time between drug and mucosa, thus increasing bioavailability. It can be loaded with nearly any pharmaceutical preparation and delivered a variety of mucosal tissues. Reduced mucociliary clearance of intranasally-applied drugs is desirable to reduce the naturally-occurring washing out of topically applied medications. The objective of the current Phase IV, randomized, double-blind, cross-over study, was to evaluate the frequency of use and efficacy of SINOL and SINOL + MucoAd™ (Sinol-M) and to demonstrate non-inferiority of Sinol-M versus the existing product Sinol. Additionally, as most homeopathic drugs are not supported by prospective clinical data there is a belief among many mainstream healthcare practitioners, and some consumers that these products do not work. This study therefore provides an opportunity to demonstrate improved efficacy versus no treatment (during the run-in and washout phases).

Official Title
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SINOL + MucoAd™ (SMAN) Evaluation Trial: A Double-Blind, Cross-Over Comparison of SINOL and SMAN in Subjects With Congestion Due to Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Sinol or Sinol-M nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to participate as indicated by providing written informed consent 12 years of age or older, of any gender and any race Have had a positive skin prick and/or intradermal test for a currently prevalent allergen within the past 5 years A history of allergic rhinitis, for at least 2 years Have undergone washout of all medications that could have an influence on the study Willing and able to make required study visits Able to follow instructions and record diary symptoms. Free of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations on nasal examination Have a TNSS between 4 and 12 averaged over the 7 days immediately prior to V2 Have an average individual score for nasal congestion greater than or equal to 2 over the 7 days immediately prior to V2. Exclusion Criteria: any concurrent disease that could interfere with the investigation or evaluation of the study medications such as: rhinitis medicamentosa or large obstructive nasal polyps any other anatomic nasal deformity that could interfere with their participation in the study asthma, with the exception of mild intermittent asthma congestion that, in the opinion of the study investigator, could interfere with successful nasal drug administration/absorption (in either nostril) use of systemic corticosteroids (oral, parenteral, intravenous, rectal) or inhaled or ocular corticosteroids within the last 30 days be undergoing allergy immunotherapy, unless on a stable dosing regimen throughout the course of the study Be using dermal potent or super-potent topical corticosteroids any systemic disorder that could interfere with the evaluation of the study medication hypersensitivity to the study drugs or any component thereof history of drug or alcohol abuse that would interfere with participation in the study history of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses that could be expected to interfere with the study upper or lower respiratory infection within 14 days of Vist 2 acute sinusitis within 30 days of Visit 2 any history or evidence of nasolacrimal drainage system malfunction Be planning to travel to an area significantly antigenically different for a substantial portion (more than 48 hours) of any given study week. participation in any other investigational study within 30 days before entry into this study or concomitantly with this study chronic or intermittent use of any prescription or over-the-counter (OTC) nasal spray during the study period

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sinol-M | Drug: Sinol or Sinol-M nasal spray<br>* One spray in each nostril up to a maximum of 12 times / day on an as needed basis<br>* Other names: Capsaicin nasal spray;|
| Active Comparator: 2<br>Sinol | Drug: Sinol or Sinol-M nasal spray<br>* One spray in each nostril up to a maximum of 12 times / day on an as needed basis<br>* Other names: Capsaicin nasal spray;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching) |  | twice daily for 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of sprays of study drug used |  | twice daily for 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Rhinitis, Capsaicin, Homeopathic, Sinol, Sinol-M