Phase 4 Chronic Rhinosinusitis Trial, Completed NCT01919411 Sponsor: Massachusetts Eye and Ear Infirmary 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 involved 89 people with chronic sinusitis who were having sinus surgery. Participants were randomly split into two groups: 43 people received a combination antibiotic (amoxicillin-potassium clavulanate) and 46 received a placebo (a dummy treatment with no active medicine). The trial was measuring two main things: how people felt about their sinus symptoms using a questionnaire called the SNOT-22 (where higher scores mean worse symptoms, on a scale of 0 to 110), and how the sinuses looked during a camera examination using a scoring system called the Lund Kennedy score (where higher scores mean more disease visible, on a scale of 0 to 20). The reported data shows that at the start of the study, both groups had very similar SNOT-22 symptom scores — 31.3 for the antibiotic group and 31.0 for the placebo group. At a later follow-up point, the antibiotic group's score had dropped to 22.3, while the placebo group's score had dropped to 17.5. For the camera examination scores, the reported data shows starting scores of 5.6 (antibiotic group) and 5.9 (placebo group), which later shifted to 4.3 and 4.5 respectively. The trial did not report whether the differences between the two groups were considered meaningful beyond these raw numbers. The reported data also shows that post-operative infections were recorded as an additional measure. In one time period, 1 participant in the antibiotic group and 0 in the placebo group had a post-operative infection recorded; in a second time period, no infections were recorded in either group. 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

NCT01919411
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 been diagnosed with chronic sinusitis (long-term inflammation or infection of the sinuses) as defined by recognised medical guidelines
  • Your doctor has decided you need surgery because your symptoms have not improved after trying the maximum level of medical treatment
  • Your previous treatment included a course of antibiotics (either broad-spectrum or chosen based on a culture test) used together with a steroid nasal spray

Who may not be able to join:

  • You are allergic to penicillin, cephalosporin, or amoxicillin/clavulanate (types of antibiotics)
  • You have Cystic Fibrosis
  • You have a weakened or impaired immune system
  • You have any packing material (dissolving or non-dissolving) left in place after your surgery
  • Your sinus problems are caused by a dental or tooth-related issue
  • You have a fungal ball (a clump of fungus) in your sinuses
  • You have an infected mucocele (a blocked, mucus-filled sac in the sinuses)
  • You have developed serious complications from sinusitis, such as meningitis, an eye/eye socket problem, a skin infection (cellulitis), or a brain abscess
  • Your sinus surgery is not done using an endoscope (a small camera inserted through the nose) — for example, if it involves older open surgical techniques
  • You are under 18 years of age
  • You are pregnant

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
Sponsor
Massachusetts Eye and Ear Infirmary
Registry
ClinicalTrials.gov
Start date
1 February 2013
Est. completion
1 September 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Sinonasal Outcome Test - 22; Sinonasal Outcome Test - 22

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