- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00825656
Comparative Study of Sinol and Sinol-M in Patients With Congestion Due to Allergic Rhinitis (SMAN)
SINOL + MucoAd™ (SMAN) Evaluation Trial: A Double-Blind, Cross-Over Comparison of SINOL and SMAN in Subjects With Congestion Due to Allergic Rhinitis
Study Overview
Status
Conditions
Intervention / Treatment
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-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).
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
-
Wheaton, Maryland, United States, 20902
- Institute for Allergy and Asthma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Sinol-M
|
One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis
Other Names:
|
Active Comparator: 2
Sinol
|
One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)
Time Frame: twice daily for 28 days
|
twice daily for 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of sprays of study drug used
Time Frame: twice daily for 28 days
|
twice daily for 28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Martha White, MD, Institute for Allergy and Asthma
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Dermatologic Agents
- Antipruritics
- Capsaicin
Other Study ID Numbers
- SMAN-0708
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
ALK-Abelló A/SCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
West Penn Allegheny Health SystemPennsylvania Allergy and Asthma Research FoundationCompletedAllergy | Perennial Allergic Rhinitis | Seasonal Allergic RhinitisUnited States
-
Ahn-Gook Pharmaceuticals Co.,LtdSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University... and other collaboratorsCompletedAllergic Rhinitis | Perennial Allergic Rhinitis | Non-seasonal Allergic RhinitisKorea, Republic of
-
United Allergy ServicesCompletedPerennial Allergic Rhinitis With Seasonal VariationUnited States
Clinical Trials on Sinol or Sinol-M nasal spray
-
Concordia University, MontrealCompleted
-
Organon and CoCompleted
-
Universitair Ziekenhuis BrusselCompletedFertility | Reproductive Endocrinology | Optimal Stimulation ProtocolBelgium
-
Taipei Medical University Shuang Ho HospitalMinistry of Science and Technology, TaiwanCompleted
-
Yale UniversityNational Cancer Institute (NCI)Active, not recruitingTobacco Use CessationUnited States