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NCT04242368
Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
Phase 2, PHASE3 trial testing Isotonic saline in Chronic Rhinosinusitis (Diagnosis). Withdrawn.
1 July 2021
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 1 July 2020 |
| Primary completion | 1 July 2021 |
| Estimated completion | 1 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Isotonic saline — full drug profile →
- Hypertonic Nasal Wash — full drug profile →
- Fluticasone Propionate (FLUTICASONE PROPIONATE) — full drug profile →
Conditions studied
- Chronic Rhinosinusitis (Diagnosis) — all drugs for Chronic Rhinosinusitis (Diagnosis) →
Sponsor
Stanford University
Who can join
18 and older, any sex, with Chronic Rhinosinusitis (Diagnosis). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Other recruiting trials for Chronic Rhinosinusitis (Diagnosis)
Currently open trials in the same condition.
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Other Stanford University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04242368 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stanford University
- Last refreshed: 18 March 2021
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