Trial · NCT05575037
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nasal fluid levels of LTE4 | At Week 8 (Visit 3) | The nasal fluid levels of LTE4 will be measured at week 8 and will serve as a surrogate biomarker of respiratory mast cell activation or burden. |
| Secondary | Nasal fluid levels of albumin | At Week 8 (Visit 3) | The nasal fluid levels of albumin will be measured at week 8 and serve as a surrogate biomarker of nasal epithelial cell integrity. |
| Secondary | Sense of smell - University of Pennsylvania Smell Identification Test (UPSIT) | At Week 8 (Visit 3) | Patients' sense of smell will be assessed at week 8 using the UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified) |
| Secondary | Rhinoscopic Total Polyp Score (TPS) | At Week 8 (Visit 3) | The extent of patients' nasal polyps will be assessed at week 8 using a TPS. The TPS scale goes from 0 (no polyps) to 8 (large polyps bilaterally), with 0 being best and 8 being worst. |
| Secondary | Peak Nasal Inspiratory Flow (PNIF) | At Week 8 (Visit 3) | Patients' nasal congestion will be assessed at week 8 by a PNIF. PNIF goes from 0 mL (no airflow) to 500 mL of airflow, with 0 being worst. |
| Secondary | Quality of life - 22-Item Sino-Nasal Outcome Test (SNOT-22) | At Week 8 (Visit 3) | Quality of life will be assessed at week 8 with a SNOT-22. For the SNOT-22, the scores range from 0 (no symptoms, excellent disease control) to 110 (maximum sinus symptoms, poor disease control). |
| Secondary | Lung function - Forced Expiratory Volume 1 (FEV1) | At Week 8 (Visit 3) | Patients' lung function will be assessed at week 8 with an FEV1. |
| Secondary | Asthma control - Asthma Control Questionnaire-6 (ACQ-6) | At Week 8 (Visit 3) | Asthma control will be measured at week 8 with an ACQ-6. For the ACQ-6, scores ranging from 0 (well-controlled) to 6 (extremely poorly-controlled). A lower score indicates better asthma control. |
| Secondary | Number of treatment-related adverse events (AEs) and serious adverse events (SAEs) leading to study drug discontinuation | At Week 8 (Visit 3) | Safety will be measured by the number of treatment-related AEs and SAEs leading to dupilumab discontinuation. |
| Other | Change in sense of smell - University of Pennsylvania Smell Identification Test (UPSIT) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in UPSIT. The UPSIT scale goes from 0 to 40, with 0 being worse (no scents identified) and 40 being best (all scents identified) |
| Other | Change in Rhinoscopic Total Polyp Score (TPS) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in TPS. The TPS scale goes from 0 (no polyps) to 8 (large polyps bilaterally), with 0 being best and 8 being worst. |
| Other | Change in Peak Nasal Inspiratory Flow (PNIF) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in PNIF. PNIF goes from 0 mL (no airflow) to 500 mL of airflow, with 0 being worst. |
| Other | Change in 22-Item Sino-Nasal Outcome Test (SNOT-22) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in SNOT-22. For the SNOT-22, the scores range from 0 (no symptoms, excellent disease control) to 110 (maximum sinus symptoms, poor disease control). |
| Other | Change in lung function - Forced Expiratory Volume 1 (FEV1) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in FEV1. |
| Other | Change in Asthma control - Asthma Control Questionnaire-6 (ACQ-6) | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in ACQ-6. For the ACQ-6, scores ranging from 0 (well-controlled) to 6 (extremely poorly-controlled). A lower score indicates better asthma control. |
| Other | Change in Nasal fluid levels of eicosanoids | weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in nasal fluid eicosanoid levels. |
| Other | Change in Nasal fluid levels of albumin | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in nasal fluid albumin levels. |
| Other | Change in urinary levels of eicosanoids | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in urinary eicosanoid levels. |
| Other | Change in serum tryptase | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in serum tryptase levels. |
| Other | Change in IgE levels | 2 weeks (between Visit 1 and Visit 2) and 8 weeks (between Visit 1 and Visit 3) | Change from Visit 1 to Visit 2 and from Visit 1 to Visit 3 in nasal fluid and plasma levels of IgE. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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