Phase 4 Chronic Rhinosinusitis Trial, Completed NCT02696850 Sponsor: Washington University School of Medicine Condition: Chronic Rhinosinusitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02696850) enrolled 80 adults in total — 40 in a group receiving budesonide (a steroid medicine) added to a saltwater nasal rinse, and 40 receiving a saltwater (saline) rinse alone. The trial was measuring changes in nasal and sinus symptoms over four weeks, using a questionnaire called the SNOT-22, which asks people to rate how much their sinus-related symptoms bother them. Of those who started, 29 people in the budesonide group and 32 in the saline-alone group completed the study. The reported data shows that the primary measure — the change in SNOT-22 symptom scores from the start to four weeks later — was 20.7 points in the budesonide group and 13.6 points in the saline-alone group. On this scale (which runs from -110 to 110), a positive number means scores moved in a favourable direction over the four weeks, with higher positive numbers indicating a greater reported improvement in symptoms. For a secondary measure, participants were asked to rate their overall response to treatment on a scale from 1 (very much improved) to 7 (very much worse); the reported data shows 24 participants in the budesonide group and 20 in the saline-alone group responded to this question, though the specific breakdown of their individual ratings was not reported in the data. An additional measure looked at changes in nasal passage appearance assessed by a doctor (endoscopic scores), with the budesonide group recording a change of 3.4 points and the saline-alone group recording 2.7 points on a 0–20 scale, where larger positive changes reflect a more favourable result. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Chronic Rhinosinusitis Trial, Completed

NCT02696850
Completed Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had at least two of the following symptoms for 12 weeks or longer: mucus dripping from the front or back of your nose, a blocked or congested nose, pain or pressure or a feeling of fullness in your face, or a reduced sense of smell.
  • A doctor has confirmed signs of inflammation in your sinuses or nasal passages, shown by things like discoloured mucus or swelling inside the nose, nasal polyps (small growths in the nose), or a scan showing inflammation in your sinuses.

Who may not be able to join:

  • You are not able to speak English.
  • You have a condition affecting how tiny hair-like structures in your airways work, such as cystic fibrosis or a similar condition.
  • You rely on long-term steroid tablets or injections to manage another health condition, such as asthma or a chronic lung condition.
  • You have taken antibiotic tablets or received antibiotic treatment in the past 2 weeks.
  • You have had surgery on your nose or sinuses in the past 6 weeks.
  • You have a history of a fluid leak from around the brain or spinal cord (confirm with trial site).
  • You are allergic to budesonide (a type of steroid medicine) or any other similar steroid sprays or treatments.
  • You are currently pregnant or breastfeeding.
  • You currently have, or have a history of, tuberculosis (TB) or a herpes infection affecting the eye.
  • Your symptom score on a standard sinus questionnaire (called the SNOT-22) is below 9, meaning your symptoms may not be severe enough for the trial's requirements (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Completed
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 January 2016
Est. completion
13 April 2017

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in SNOT-22 (Sino-Nasal Outcome Test)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov