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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Strategic Biosciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Strategic Biosciences
ClinicalTrials.gov Identifier:
NCT00825656
First received: January 19, 2009
Last updated: January 21, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Drug: Sinol or Sinol-M nasal spray
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Strategic Biosciences:

Primary Outcome Measures:
  • Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching) [ Time Frame: twice daily for 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of sprays of study drug used [ Time Frame: twice daily for 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sinol-M
Drug: Sinol or Sinol-M nasal spray
One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis
Other Name: Capsaicin nasal spray
Active Comparator: 2
Sinol
Drug: Sinol or Sinol-M nasal spray
One spray in each nostril up to a maximum of 12 times / day on an "as needed" basis
Other Name: Capsaicin nasal spray

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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825656

Locations
United States, Maryland
Institute for Allergy and Asthma
Wheaton, Maryland, United States, 20902
Sponsors and Collaborators
Strategic Biosciences
Investigators
Principal Investigator: Martha White, MD Institute for Allergy and Asthma
  More Information

No publications provided

Responsible Party: Martha WhiteMD, CPI, Institute for Asthma and Allergy
ClinicalTrials.gov Identifier: NCT00825656     History of Changes
Other Study ID Numbers: SMAN-0708
Study First Received: January 19, 2009
Last Updated: January 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Strategic Biosciences:
Allergic Rhinitis
Capsaicin
Homeopathic
Sinol
Sinol-M

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014