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

Primary Purpose

Allergic Rhinitis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sinol or Sinol-M nasal spray
Sponsored by
Strategic Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic Rhinitis, Capsaicin, Homeopathic, Sinol, Sinol-M

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Allergy and Asthma

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Sinol-M

Sinol

Outcomes

Primary Outcome Measures

Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)

Secondary Outcome Measures

Number of sprays of study drug used

Full Information

First Posted
January 19, 2009
Last Updated
January 21, 2009
Sponsor
Strategic Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT00825656
Brief Title
Comparative Study of Sinol and Sinol-M in Patients With Congestion Due to Allergic Rhinitis
Acronym
SMAN
Official Title
SINOL + MucoAd™ (SMAN) Evaluation Trial: A Double-Blind, Cross-Over Comparison of SINOL and SMAN in Subjects With Congestion Due to Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
January 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Strategic Biosciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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-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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic Rhinitis, Capsaicin, Homeopathic, Sinol, Sinol-M

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sinol-M
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sinol
Intervention Type
Drug
Intervention Name(s)
Sinol or Sinol-M nasal spray
Other Intervention Name(s)
Capsaicin nasal spray
Intervention Description
One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis
Primary Outcome Measure Information:
Title
Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)
Time Frame
twice daily for 28 days
Secondary Outcome Measure Information:
Title
Number of sprays of study drug used
Time Frame
twice daily for 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha White, MD
Organizational Affiliation
Institute for Allergy and Asthma
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Allergy and Asthma
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States

12. IPD Sharing Statement

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

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