Phase 2 Chronic Rhinosinusitis Trial, Completed NCT01955980 Sponsor: Pari Pharma GmbH 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 compared two nasal spray treatments — called "Buparid" (Treatment A) and "Budes" (Treatment B) — in people with inflammation of the nasal passages and sinuses. A total of 19 people took part: 10 in the Buparid group and 9 in the Budes group. All participants who started the trial completed it. The trial measured changes in sinus inflammation using medical imaging scores, self-reported quality of life, and nasal airflow, as well as tracking unwanted side effects. The reported data shows the following numbers. For the main measure — a sinus inflammation score based on MRI scans (where 0 means no inflammation and 24 means the most severe) — the Buparid group showed a change of 0 points from the start, while the Budes group showed a change of −0.8 points (a small decrease). For quality of life (scored 0–100, where higher means more impairment), the reported change scores after 48 weeks were 17.1 for the Buparid group and 22.9 for the Budes group — noting that these appear to represent changes from the starting point, though the direction of change is not fully detailed in the submitted data. For nasal airflow (measured in millilitres per second), readings were taken at two time points: at 4 weeks, the Buparid group recorded 542.4 ml/sec and the Budes group 582.0 ml/sec; at 8 weeks, the figures were 461.5 ml/sec and 551.5 ml/sec respectively. Regarding unwanted events (side effects), 6 participants in each group were reported to have experienced at least one treatment-related adverse event. Data for one secondary measure — MRI-based mucosa thickness — was not reported in the submitted results. 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

NCT01955980
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 officially diagnosed with chronic rhinosinusitis (long-term inflammation of the sinuses)
  • Surgery on your sinuses is currently the only other option available to you
  • You are willing and able to give written consent before any tests or study procedures begin
  • You are male or female, aged 18 or older
  • You are able to receive nasal treatment without any restrictions
  • You are able to correctly use a device called the PARI SINUS (a specialised nasal inhaler)
  • You are able to understand what the trial involves and what the risks are
  • If you are a woman who could become pregnant, you must have a negative urine pregnancy test before starting the trial medication
  • The trial doctor believes you are suitable to take part

Who may not be able to join:

  • You have cystic fibrosis
  • You have nasal polyps (growths inside the nose), at any grade
  • You have previously had a type of sinus surgery called FESS (Functional Endoscopic Sinus Surgery)
  • You are currently pregnant or breastfeeding
  • You have had an active bacterial, viral, or fungal infection in the week before starting the trial medication
  • You have abnormal results for vital signs, blood tests, or kidney or liver function tests (confirm with trial site)
  • The trial team thinks it is unlikely you will attend all visits or follow all the study procedures
  • You have taken part in another clinical trial and received an experimental drug within the past 4 weeks
  • You have another medical condition that the trial doctor believes would significantly increase your risk of harm from taking part
  • You have a psychiatric condition or mental health issue that would prevent you from understanding the consent process or completing the study requirements
  • You currently misuse drugs or alcohol
  • You have an advanced or end-stage cancer
  • You are known to be allergic to a medicine called Budesonide (a type of steroid)
  • You have taken steroid tablets or capsules by mouth at any point in the last 3 months
  • You need more than 1 mg per day of Budesonide (or an equivalent steroid) to manage your asthma
  • You are currently taking certain medicines, including leukotriene receptor antagonists, decongestants, antihistamines, or antibiotics (confirm with trial site which specific medicines apply)
  • You have frequent nosebleeds, happening more than once a week

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.

GP referral letter

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

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Pari Pharma GmbH
Registry
ClinicalTrials.gov
Start date
27 October 2015
Est. completion
27 September 2018

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