Phase 2 Chronic Rhinosinusitis Trial, Completed NCT01946711 Sponsor: Pari Pharma GmbH 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 14 people in total — 8 in the "Buparid" group (Treatment A) and 6 in the "Budes" group (Treatment B). All 14 participants completed the trial. The study was measuring changes in inflammation of the nasal passages and sinuses, using a scoring system called the Lund-Mackay score (based on MRI scans), where a score of 0 means no impairment and 24 means the most severe impairment. It also looked at side effects, quality of life, and nasal airflow. The reported data shows that, for the primary measure — change in nasal and sinus inflammation — the Buparid group's average score went down by 2 points, while the Budes group's average score went down by 0.8 points. A lower (more negative) change means the score reduced from where it started. For the secondary measure of side effects, 5 out of 8 participants in the Buparid group and 4 out of 6 in the Budes group experienced at least one adverse event (an unwanted or unexpected health event noticed during the trial). For quality of life, measured using a 22-question survey (scored 0–110, where higher means more difficulty), the reported average change from the start of the trial to 24 weeks was an increase of 23.6 points in the Buparid group and 14.4 points in the Budes group — noting that a higher number here indicates more reported difficulty. For nasal airflow, measured at two time points (4 and 8 weeks), the reported figures were not described in a way that allows straightforward comparison without additional context, but the raw values ranged from 574 to 755 ml/sec across both groups and time points. It is worth noting that this was a very small trial, and some details — such as what the scores were at the start of the trial — were not fully reported in the structured data, so the full picture of the changes cannot be described here. 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 2 Chronic Rhinosinusitis Trial, Completed

NCT01946711
Completed Phase 2

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 rhinosinusitis (long-term sinus inflammation) with nasal polyps graded as level I, II, or III
  • You have a minimum level of airflow measurable through each side of your nose separately (confirmed by a specific breathing test called PNIF showing more than 7 litres per minute on each side)
  • You are willing and able to sign a written consent form
  • You are male or female and are 18 years of age or older
  • You are able to receive treatment applied inside the nose without any restrictions
  • You are able to understand the purpose and risks of the clinical trial
  • If you are a woman who could become pregnant, you must have a negative urine pregnancy test before the study treatment starts
  • You have correctly filled in a diary during the initial lead-in phase of the trial

Who may not be able to join:

  • You have cystic fibrosis
  • You have nasal polyps at the most severe grade (grade IV)
  • You have previously had surgery on your sinuses or nose, unless it was only a simple polyp removal
  • You have a condition affecting the tiny hair-like structures in your airways called cilia (confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You appear to have an active infection in your upper airways (such as a cold or sinus infection)
  • You have taken part in another clinical drug trial within the last 4 weeks
  • You have a current problem with drug or alcohol misuse
  • You have a serious, advanced-stage cancer
  • You have a known allergy or sensitivity to a medication called Budesonide
  • You have taken steroid tablets or capsules by mouth within the last 4 weeks
  • You get nosebleeds frequently (more than twice a month)

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 2: approximately ~30% 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 2
Sponsor
Pari Pharma GmbH
Registry
ClinicalTrials.gov
Start date
28 August 2013
Est. completion
3 February 2020

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Change of Inflammation of the Nasal Mucosa and Paranasal Sinus

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