SINOL + MucoAd™ (SMAN) Evaluation Trial: A Double-Blind, Cross-Over Comparison of SINOL and SMAN in Subjects With Congestion Due to Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
1
Sinol-M
干预措施: Sinol or Sinol-M nasal spray (Drug)
2
Sinol
干预措施: Sinol or Sinol-M nasal spray (Drug)
结局指标
主要结局
Daily Total Nasal Symptom Score (congestion, rhinorrhea, sneezing, nasal itching)
时间窗: twice daily for 28 days
次要结局
- Number of sprays of study drug used(twice daily for 28 days)