Chronic Rhinosinusitis Trial, Terminated NCT02454608 Sponsor: Benjamin Bleier Condition: Chronic Rhinosinusitis
Back to Chronic Rhinosinusitis

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 (NCT02454608) involved two main phases. In the first phase — a double-blind period (meaning neither participants nor researchers knew who received which treatment) — 15 people were in the Treatment group and 14 were in the Control group, and all 15 in the Treatment group completed this phase compared with 12 in the Control group. After this, 29 participants moved into an open-label period (where everyone knew what was being given), though only 10 of those 29 completed that second phase. The trial was measuring sinonasal symptoms — that is, symptoms related to the nose and sinuses — using a combination of patient-reported questionnaires and scores assessed by clinicians. The reported data shows the following changes in scores from the start of the trial to the end of the double-blind period. On the SNOT-22 questionnaire (a symptom rating scale from 0 to 110, where higher means worse), the Treatment group's average score changed by −27.3 points, while the Control group's average changed by +0.4 points. On a separate 0–100 visual scale where participants rated their own symptoms, the Treatment group showed a change of −44.03 points and the Control group showed −6.07 points. For the clinician-assessed Lund-Kennedy Score (0–12, higher is worse), the Treatment group changed by −1.3 and the Control group by −0.25. For the Lund-McKay Score — a CT scan-based score (0–24, higher is worse) — the reported values were 12.5 for the Treatment group and 17.7 for the Control group; it is not entirely clear from the submitted data whether these represent changes or end-point scores, so this figure should be interpreted with caution. Heart rate and blood pressure were also recorded, though the data submitted does not include the context needed to draw conclusions from those figures. 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.

Chronic Rhinosinusitis Trial, Terminated

NCT02454608
Terminated Not Applicable

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 are being seen or treated at the Massachusetts Eye and Ear Sinus Center
  • You are between 18 and 80 years old
  • You have been diagnosed with chronic rhinosinusitis (long-term sinus inflammation) with nasal polyps, confirmed using recognised medical guidelines (EPOS 2012)

Who may not be able to join:

  • You have slow or impaired movement of food through your digestive system (GI hypomotility)
  • You have heart failure
  • You have liver failure
  • You have any form of kidney disease
  • You have muscular dystrophy
  • You are pregnant or currently breastfeeding
  • You depend on steroids as part of your regular treatment
  • You currently take aspirin
  • You currently take beta-blockers (a type of heart or blood pressure medication)
  • You currently take cimetidine (Tagamet)
  • You currently take clarithromycin (Biaxin)
  • You currently take cyclosporin
  • You currently take digoxin
  • You currently take disopyramide (Norpace)
  • You currently take diuretics (water pills)
  • You currently take erythromycin
  • You currently take flecainide
  • You currently take HIV protease inhibitors (such as Indinavir, Nelfinavir, or Ritonavir)
  • You currently take quinidine
  • You currently take lithium
  • You currently take pioglitazone
  • You currently take rifampin
  • You currently take St. John's Wort (a herbal supplement)
  • A screening heart tracing (ECG/EKG) shows any abnormality in your heart's rhythm or electrical activity

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Terminated
Phase
Not Applicable
Sponsor
Benjamin Bleier
Registry
ClinicalTrials.gov
Start date
1 May 2015
Est. completion
1 March 2016

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22); Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS); Subjective Sinonasal Symptoms on Sinonasal Outcomes Test-22(SNOT-22); Subjective Sinonasal Symptoms on 10cm Visual Analogue Scale(VAS)

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