A clinical trial to investigate the potential of Buparid/PARI SINUS versus Budes® Nasal Spray to avoid or postpone sinus surgery in adult patients with Chronic Rhinosinusitis (CRS)

Phase 1

• Conditions: Chronic Rhinosinusitis (CRS); Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2013-002421-30-DE
• Lead Sponsor: PARI Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-12
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified