A randomised, open, controlled pilot study to investigate the potential ofBuparid/PARI SINUS versus Budes® Nasal Spray to avoid or postponesinus surgery in adult patients with Chronic Rhinosinusitis (CRS)

PARI Pharma GmbH0 个研究点目标入组 20 人开始时间: 2014年5月12日最近更新: 2021年8月10日

适应症

试验速览

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•1. Patient with confirmed diagnosis of chronic rhinosinusitis (CRS), i.e. inflammation of nasal mucosa and paranasal sinus. Diagnosis is based on history of symptoms (nasal obstruction, running nose, postnasal drip, facial pain and hyposmia with a duration of > 3 months) and on MRT-imaging
•2. Patient without alternative other than sinus surgery
•3. Patient’s written informed consent obtained prior to any screening or study-specific procedure
•4. Male or female, equal/over 18 years of age
•5. Patient is able to undergo nasal therapy without restrictions
•6. Capable to correctly use the PARI SINUS device 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
•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

•1. Patients with cystic fibrosis
•2. Patients with polyposis nasi grade I-IV
•3. Patients with prior FESS (Functional Endosopic Sinus Surgery)
•4. Pregnant or breastfeeding women
•5. Any active invasive bacterial, viral or fungal infection within
•one week prior to first investigational medicinal product administration
•6. No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function
•7. Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
•8. Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
•9. 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
•10. Psychiatric disorders or altered mental status precluding
•understanding of the informed consent process and/or completion of the necessary procedures
•11. Drug or alcohol abuse
•12. End-stage malignancies
•13. Known hypersensitivity to Budesonide
•14. Patients with oral steroid therapy within the last 3 months
•15. Patients needing > 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma
•16. Patients on therapy with leukotriene receptor
•antagonists, decongestants, antihistamines or antibiotics
•17. Patients with frequent epistaxis (> 1 episode per week)

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