Trial · NCT07591753
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete and Partial Response | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients achieving complete response or partial response during follow-up. Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day. Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose \>4.0 mg/day. |
| Primary | Change in Lung Function | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) during follow-up. |
| Primary | Disease relapses | Up to 60 months (assessed at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients with disease relapse during follow-up. Relapse is defined as active vasculitis (BVAS\>0) and/or worsening asthma or ENT manifestations leading to oral corticosteroid increase to \>4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization. |
| Primary | Respiratory Exacerbations | Up to 60 months (assessed at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients with respiratory exacerbations during follow-up. Respiratory exacerbations are defined as asthma attack requiring an increase in oral corticosteroid dose \>30%, emergency department admission related to asthma, and/or use of acute oral corticosteroids, antibiotics, or short-acting beta-agonists. |
| Secondary | Proportion of Patients With at Least One Adverse Event or Serious Adverse Event | Up to 60 months from mepolizumab initiation (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients with at least one adverse event (AE) or serious adverse event (SAE) during treatment with mepolizumab 300 mg/4 weeks. Safety events are retrieved from medical charts and summarized as aggregated data. |
| Secondary | Persistance | Up to 60 months from mepolizumab initiation (at 3, 6, 12, 24, 36, 48, and 60 months) | Persistence on mepolizumab, assessed in terms of dose switching and treatment discontinuation during follow-up. |
| Other | Changes in Organ Manifestations | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | The proportion of patients with active symptoms will be calculated over the total number of patients with available data for the given timepoint. |
| Other | Oral Corticosteroid-Sparing Effect | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Median daily oral corticosteroid dose and proportion of patients achieving a daily oral corticosteroid dose of 0 during follow-up |
| Other | DMARD-Sparing Effect | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of patients discontinuing DMARD treatment that was ongoing or newly started at baseline. |
| Other | Variation in ANCA Positivity | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Proportion of ANCA-positive patients at each timepoint and ANCA negativization among patients positive for ANCA at baseline. |
| Other | Variation in Eosinophil Count | Baseline and up to 60 months (at 3, 6, 12, 24, 36, 48, and 60 months) | Median eosinophil count during follow-up in patients with available data for each timepoint. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07591753/registered