Trial · NCT05692180
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to first asthma exacerbation | From Baseline (Week 0) to End of Treatment (EOT) in DB treatment period | The effect of benralizumab on asthma exacerbations in paediatric and adolescent patients with uncontrolled asthma will be evaluated. |
| Secondary | Change from baseline, during the DB treatment period in Interviewer-Administered Version of the Asthma Control Questionnaire (ACQ-IA) | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in Asthma symptom score | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in rescue medication use | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in night-time awakenings due to asthma | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Change from baseline, during the DB treatment period in peak expiratory flow (PEF) | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma control and symptoms will be assessed. |
| Secondary | Serum benralizumab trough concentration | During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period | The pharmacokinetics of benralizumab will be characterised. |
| Secondary | Anti-benralizumab antibodies | During Day -7, Day 56, Day 112, every 16 weeks and at EOT DB treatment period | The immunogenicity of benralizumab will be characterised. |
| Secondary | Change from baseline, during the DB treatment period in Paediatric Asthma Quality of Life Questionnaire-Interviewer Administered (PAQLQ-IA) total score | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on asthma health-related quality of life will be assessed. |
| Secondary | Change from baseline, during the DB treatment period, in spirometry, for pre-dose/pre-bronchodilator forced expiratory volume in one second (FEV1) | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on pulmonary function (FEV1) will be assessed. |
| Secondary | Change from baseline, during the DB treatment period, in spirometry, for post-bronchodilator FEV1 | From Baseline (Week 0) to EOT in DB treatment period | The effect of benralizumab on pulmonary function (FEV1) will be assessed. |
| Secondary | The Annualised asthma exacerbation rate (AAER) in the DB treatment period | From Screening until the EOT double blind treatment period | The asthma exacerbations reported during the DB treatment period of the study will be described. |
| Other | Number of patients with Adverse events (AEs) and Serious adverse events (SAEs) | From Screening period until EOT DB treatment period | The safety and tolerability of benralizumab will be evaluated. |
| Other | The AAER in the OLE period | From Week 0 until the EOT OLE period | The annualised rate of severe exacerbations in the OLE period will be assessed. |
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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GET https://conductscience.org/api/trials/v1/NCT05692180/registered