Status:
UNKNOWN
Comparative Study of Sinol and Sinol-M in Patients With Congestion Due to Allergic Rhinitis
Lead Sponsor:
Strategic Biosciences
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
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
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-n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00825656
Start Date
September 1 2008
End Date
January 1 2009
Last Update
January 23 2009
Active Locations (1)
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1
Institute for Allergy and Asthma
Wheaton, Maryland, United States, 20902