Phase 3 Chronic Rhinosinusitis Trial, Completed NCT01197612 Sponsor: University of Michigan 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, 18 people started this trial, which looked at whether a nasal rinse containing a steroid medication (Pulmicort) made a difference to smell ability and sinus health. Unusually, the trial used each participant's own two nostrils as a comparison — one nostril received the treatment and the other did not. Only 6 participants completed the full 24-week study, while 12 did not finish. The reported data shows that smell ability was measured using a standardised test called the UPSIT, which runs from 0 (unable to smell anything) to 40 (perfect smell identification). At the primary measurement point, the treated nostril side scored 20.2 and the untreated nostril side scored 19.8 out of 40. A second measurement of smell ability reported scores of 20.4 (treated side) and 20.0 (untreated side). For sinus health, a scale called the POSE score was used, running from 0 (no blockage) to 20 (greatest blockage). The reported data shows scores of 4.5 (treated) versus 4.7 (untreated) at one measurement point, and 5.6 versus 5.6 at another. No other outcome figures were reported in the submitted data. It is worth noting that the small number of people who completed the trial — just 6 out of 18 — means the reported numbers are based on a very limited group, and this is an important limitation to be aware of when reading these 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.

Phase 3 Chronic Rhinosinusitis Trial, Completed

NCT01197612
Completed Phase 3

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 a reduced sense of smell and a blocked nose for more than 12 weeks
  • You have nasal polyps (small, non-cancerous growths) inside both nostrils
  • Your doctor has determined that you are a suitable candidate for surgery

Who may not be able to join:

  • You have a weakened immune system (for example, due to illness or medication)
  • You do not speak English
  • You are currently in prison
  • You are pregnant or breastfeeding
  • You are unable or unwilling to attend follow-up appointments after the trial

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
1 September 2010
Est. completion
1 June 2012

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Olfaction

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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