EUCTR2013-002414-12-DE进行中（未招募）1 期
A randomised, open, controlled pilot study to investigate the efficacy and safety of Buparid/PARI SINUS versus Budes® Nasal Spray in the therapy of Chronic Rhinosinusitis (CRS) with polyposis nasi in adult patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient with confirmed diagnosis of chronic rhinosinusitis (CRS), i.e. inflammation of nasal mucosa and paranasal sinus, with polyposis nasi grade I-III (according to Rasp et al. 2000). Diagnosis is based on history of symptoms (nasal obstruction, running nose, postnasal drip, facial pain and hyposmia with a duration of > 3 months (according to EPOS3) and on MRT-imaging using the Lund-Mackey Score)
- •2.Patient with a PNIF (positive nasal inspiratory flow) of > 7 l/min separated for left and right side of the nose
- •3.Patient’s written informed consent obtained prior to any screening or study-specific procedure
- •4.Male or female, equal and older 18 years of age
- •5.Patient is able to undergo nasal therapy without restrictions
- •6.Capable to correctly use the PARI SINUS device (closing of the soft palate) in accordance with the package insert
- •7.Capable of understanding the purpose and risk of the clinical trial
- •8.Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration. Both women and men must agree to use a medically acceptable method of contraception throughout the IMP treatment period and for 3 months after IMP discontinuation.
- •9.Patient is able to participate in the study according to Investigator’s opinion
- •10.Patient has completed correctly the diary during the Wash-in Phase
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Patients with cystic fibrosis
- •2.Patients with CSR without polyposis nasi
- •3.Patients with polyposis nasi grade IV
- •4.Patients with prior sinonasal surgery (exemption: polypectomy)
- •5.Patients with primary ciliaritis
- •7.Pregnant or breastfeeding women
- •8.Patients with suspected active upper airway infection
- •9.Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
- •10.Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
- •11.Any co-existing medical condition that in the Investigator’s judgement will substantially increase the risk associated with the patient’s participation in the clinical trial
- •12.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
- •13.Drug or alcohol abuse
- •14.End-stage malignancies
- •15.Known hypersensitivity to Budesonide
- •16.Patients with oral steroid therapy within the last 4 weeks
- •17.Patients with frequent epistaxis (> 2 per month)
研究者
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