Stage 2, Double-blind, Randomized, Parallel Groups, One Centre Study in Patients With Allergic Rhinitis Treated With Nasal Oxymetazoline in Combination With Nasal Hydroxyl-propyl-methyl Cellulose (HPMC) or Placebo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Peak nasal inspiratory flow (PNIF) area under the curve (AUC) change between the placebo and active NoAl treatment on day 1
研究概览
简要总结
Allergic rhinitis is treated with a variety of systemic and locally applied drugs. The effectiveness of the intranasally applied formulations is diminished by the cleaning mechanisms of the nose, rhinorrhea in particular. Slowing down of the clearance of the nasal mucosa and prolonging the contact time of locally applied drugs with the nasal mucosa would improve their efficacy. One method is creating dosage forms containing mucoadhesive polymers. We have demonstrated that a mucoadhesive solution containing HPMC enhances the clinical efficacy of oxymetazoline. However, the industrial development of fixed combinations of pharmaceutical compound and mucoadhesive carrier requires substantial investments, escalating manifold if different pharmaceutical compounds have to be rendered mucoadhesive.
NoAl is a cellulose derivative powder, which forms a gel layer on contact with the mucosal surface of the nose blocking the contact of the pollen grains with the nasal mucosa in seasonal allergic rhinitis. However, there is another potential benefit of applying NoAl (HPMC) along with other commercially available drugs for local treatment of rhinitis, as the formation of a gel layer can substantially delay their clearance from the nose and thus increase their effectiveness. This hypothesis needs to be substantiated clinically.
详细描述
The main objective of the trial is to test the synergy between HPMC and oxymetazoline (both applied nasally) on the increase of peak nasal inspiratory flow in patients suffering from moderately severe / severe persistent allergic rhinitis.
The design of the trial is parallel-groups, double blind, randomized, placebo controlled, single centre study.
Forty patients are randomly assigned to receive either oxymetazoline followed by HPMC (Group A) or oxymetazoline followed by placebo (Group B).
Each patient is followed up for 15 days. Day 1 is the screening and inclusion visit. Data will then be collected on day 8 & 15. Patients will fill in diaries their everyday symptoms, adverse events and applied medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients
- •Age ≥ 18 and ≤ 50 years
- •Moderately severe / severe persistent allergic rhinitis
- •Positive skin prick test for perennial aero-allergens
- •Active symptoms with prominent congestion at the time of inclusion
排除标准
- •Subjects with pollen sensitization during the respective pollen season
- •Subjects with arterial hypertension, arrhythmia or evidence of heart ischemia
- •Subjects with other serious chronic comorbidities and bad therapeutic control
- •Subjects with nasal polyposis
- •Flu-like episode during the past 30 days
- •Subjects unable to give informed consent
- •Subjects with any of the contra-indications of oxymetazoline or NoAL
- •Pregnant or lactating women
研究组 & 干预措施
Group A
One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning & evening, for 8 days.
干预措施: Oxymetazoline (Drug)
Group A
One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning & evening, for 8 days.
干预措施: Hydroxyl-propyl-methyl cellulose powder (Other)
Group B
One puff of oxymetazoline immediately followed by one puff of placebo, morning & evening, for 8 days.
干预措施: Oxymetazoline (Drug)
Group B
One puff of oxymetazoline immediately followed by one puff of placebo, morning & evening, for 8 days.
干预措施: Placebo (lactose powder) (Other)
结局指标
主要结局
Peak nasal inspiratory flow (PNIF) area under the curve (AUC) change between the placebo and active NoAl treatment on day 1
时间窗: PNIF on Day 1, 8 and 15
次要结局
- Visual analogue scale (VAS) for the separate rhinitis symptoms between the two groups(On D1, D8 and D15)
- Difference between the PNIF AUC D1-D8 differences between the two groups(PNIF on D1 and D8)
- Difference in the applied rescue decongestant (total number of additional puffs of oxymetazoline or any other medications indicated for the treatment of allergic rhinitis) as needed between the two groups(For 15 days)
- Differences in nasal mucociliary clearance (Saccharine test) between both groups.(Performed on D1, D8 and D15)
- Change of total rhinitis symptom score (TRSS) over 8 days(From D1 to D8)
- Number and severity of adverse events(15 days)
- Change of each symptom score for congestion over 8 days(From D1 to D8)
研究者
Prof. Todor Popov
Professor
Association Asthma, Bulgaria
