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

Sponsored by:	Strategic Biosciences
Information provided by:	Strategic Biosciences
ClinicalTrials.gov Identifier:	NCT00825656

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 IV

Drug Information available for: Capsaicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
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

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
1: Experimental 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
2: Active Comparator 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

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

Keywords provided by Strategic Biosciences:

Allergic Rhinitis
Capsaicin
Homeopathic
Sinol
Sinol-M

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antipruritics

Rhinitis
Peripheral Nervous System Agents
Capsaicin

Additional relevant MeSH terms:

Otorhinolaryngologic Diseases
Physiological Effects of Drugs
Rhinitis
Capsaicin
Nose Diseases
Pharmacologic Actions
Respiratory Tract Diseases

Respiratory Tract Infections
Sensory System Agents
Therapeutic Uses
Antipruritics
Peripheral Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 07, 2009