Clinical Evaluation of Triamcinolone Acetonide-loaded Nanoparticles For Nasal Postoperative Application
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in 22-Item Sinonasal Outcome Test Score
研究概览
简要总结
This randomised, single-masked, parallel-group clinical trial will evaluate the efficacy and safety of a topical triamcinolone acetonide-loaded polymeric nanocapsule formulation for postoperative care following endoscopic nasal surgery.
Participants will receive either the investigational triamcinolone acetonide-loaded nanocapsule formulation or standard normal saline nasal irrigation. Postoperative nasal healing, inflammation, patient-reported sinonasal symptoms, postoperative complications, and corticosteroid-related adverse effects will be compared between the two groups.
详细描述
Postoperative care following functional endoscopic sinus surgery and other endoscopic nasal procedures is important for reducing inflammation, supporting mucosal healing, and preventing complications and disease recurrence.
Conventional topical nasal treatments may be rapidly cleared from the nasal cavity, which may reduce their contact time with the postoperative nasal mucosa.
The investigational formulation contains triamcinolone acetonide incorporated into polymeric nanocapsules prepared using a nanoprecipitation method. The nanocapsule delivery system is intended to improve local drug retention, enhance drug stability, and provide controlled release of triamcinolone acetonide at the postoperative nasal tissues.
Eligible participants will be randomly assigned to receive either topical triamcinolone acetonide-loaded polymeric nanocapsules or standard normal saline nasal irrigation following endoscopic nasal surgery.
Participants will be followed using endoscopic clinical assessments, patient-reported sinonasal symptom questionnaires, evaluation of postoperative complications, and monitoring for local or systemic corticosteroid-related adverse effects.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 60 years.
- •Patients scheduled to undergo one of the following procedures:
- •Functional endoscopic sinus surgery
- •Endoscopic turbinoplasty
- •Endoscopic septoplasty
- •Diagnosis of chronic rhinosinusitis and/or nasal polyps requiring surgical intervention.
- •Ability and willingness to provide written informed consent.
- •Ability and willingness to comply with study treatment and scheduled follow-up visits.
排除标准
- •Known hypersensitivity to triamcinolone acetonide.
- •Known hypersensitivity to any component of the polymeric nanocapsule formulation.
- •Systemic contraindication to corticosteroid therapy.
- •Active severe nasal or sinonasal infection at the time of enrollment or treatment.
- •Pregnancy or breastfeeding, if excluded in the approved protocol.
- •Uncontrolled diabetes mellitus, if corticosteroid exposure is considered clinically relevant.
- •Immunosuppression or use of immunosuppressive therapy.
- •Recent use of systemic or intranasal corticosteroids within the protocol-defined washout period.
- •Participation in another clinical trial.
- •Any medical or psychiatric condition that may interfere with informed consent, study treatment, or follow-up.
- •Inability to complete the required questionnaires or follow-up visits.
研究组 & 干预措施
Triamcinolone Acetonide Nanocapsules
Participants assigned to this arm will receive topical triamcinolone acetonide-loaded polymeric nanocapsules as postoperative nasal therapy following endoscopic nasal surgery
干预措施: Triamcinolone Acetonide-Loaded Polymeric Nanocapsules (Drug)
Normal Saline Irrigation
Participants assigned to this arm will receive standard postoperative normal saline nasal irrigation following endoscopic nasal surgery.
干预措施: Normal Saline Nasal Irrigation (Other)
结局指标
主要结局
Change in 22-Item Sinonasal Outcome Test Score
时间窗: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
Participant-reported sinonasal symptoms and health-related quality of life will be assessed using the 22-Item Sinonasal Outcome Test, SNOT-22.
Change in Lund-Kennedy Endoscopic Score
时间窗: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
The Lund-Kennedy Endoscopic Score will be used to assess postoperative nasal mucosal healing and inflammation. The score ranges from 0 to 20 and is calculated by summing the scores for polyps, discharge, oedema, scarring, and crusting (each scored 0-2 on both the left and right sides). A total score of 0 indicates no disease, and a score of 20 indicates the most severe disease. Therefore, higher scores indicate a worse outcome
Change in 22-Item Sinonasal Outcome Test Score (SNOT-22)
时间窗: Baseline, postoperative week 2, postoperative week 4, and postoperative month 3
SNOT-22 will be used to assess participant-reported sinonasal symptoms and health-related quality of life. The total score ranges from 0 to 110 and is calculated by summing the scores for 22 individual items. Each item is rated from 0 ("No problem") to 5 ("Problem as bad as it can be"). A total score of 0 indicates no disease burden, and a score of 110 indicates the maximum disease burden. Therefore, higher scores indicate a worse outcome.
次要结局
- Incidence of Postoperative Complications(From the date of surgery through postoperative month 3)
- Incidence of Corticosteroid-Related Adverse Events(From the first administration of study treatment through postoperative month 3)