Clinical Trials Logo

Clinical Trial Summary

The study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline nasal rinses as compared to isotonic saline nasal rinses in patients with chronic rhinosinusitis (CRS). Evidence from basic science research suggests that hypertonic solutions may have beneficial effects over isotonic saline rinses; however prior clinical studies on this topic have been inconclusive and limited due to highly variable inclusion criteria, large variability in the volume and concentration of irrigation solution, and inconsistent outcome measures. The goal of the study is to utilize a cross over study design to directly compare the impact of two different types of saline irrigation. Primary aim: Compare the efficacy of buffered hypertonic saline irrigations to buffered isotonic saline irrigations on patient reported outcome measures of chronic rhinosinusitis symptoms and nasal obstruction in patients with CRS. Based on in vivo data and prior clinical studies, the investigators expect participants will experience greater symptom improvement with hypertonic saline rinses as compared to isotonic saline irrigations. Hypothesis: Participants will have greater improvement in patient reported outcome measures (SNOT-22 and NOSE) when using buffered hypertonic sinus irrigations as compared to buffered isotonic saline irrigations.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Chronic Rhinosinusitis (Diagnosis)
  • Sinusitis

NCT number NCT04242368
Study type Interventional
Source Stanford University
Contact
Status Withdrawn
Phase Phase 2/Phase 3
Start date July 1, 2020
Completion date July 1, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05895929 - The Role of IL5 in Epithelial Cell Integrity Early Phase 1
Completed NCT03673956 - Topical Antibiotics in Chronic Rhinosinusitis Phase 1/Phase 2
Recruiting NCT03970655 - Functional Endoscopic Sinus Surgery Study Phase 1/Phase 2
Not yet recruiting NCT04514120 - Alsaleh-Javer Endoscopic Sinus Score (AJESS) System N/A
Recruiting NCT03963648 - NO Measurements in Screening for Asthma and OSA, in Patients With CRSwNP N/A
Recruiting NCT05009758 - Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps N/A
Active, not recruiting NCT05553951 - Adherence in Global Airways N/A
Completed NCT03563521 - Identifying Serum Cytokine Profiles of Distinct Inflammatory Phenotypes in Severe Asthma
Completed NCT05035654 - LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study) Phase 2
Withdrawn NCT03369574 - Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab
Recruiting NCT05400616 - Nasal Microbiota Transfer Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) N/A
Recruiting NCT04628442 - Tissue Immune Interaction in Nasal Polyposis
Completed NCT04041609 - LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study) Phase 2
Completed NCT04048070 - The Effect of Enhanced Recovery After Surgery in Endoscopic Sinus Surgery N/A
Recruiting NCT03439865 - Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis Early Phase 1
Recruiting NCT05857228 - Viral and Epigenetic Influences in CRSwNP
Completed NCT03122795 - Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) N/A
Recruiting NCT05295459 - Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 2) Phase 3
Completed NCT04858802 - A Clinical Evaluation of PROPEL® Contour Sinus Implant N/A
Completed NCT04572516 - Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis Phase 3