Trial · NCT04617171
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 exacerbation in patients with a severe asthma exacerbation with raised blood eosinophil count | Change from baseline (Day 1) to 52 weeks | Time to first exacerbation requiring either oral corticosteroid (OCS) use and/or an unscheduled visit to the Emergency Department or hospitalization |
| Secondary | Time to hospital readmission due to asthma exacerbation (Key Secondary outcome) | Baseline (Day 1) to 52 weeks | Time to hospital readmission due to asthma exacerbation |
| Secondary | Rate of severe exacerbation (i.e. requiring admission to hospital for asthma exacerbation) | Baseline (Day 1) to 52 weeks | NUmber of severe exacerbation (i.e. requiring admission to hospital for asthma exacerbation) |
| Secondary | Hospital LOS (index admission and subsequent admissions) | Change from baseline (Day 1) to 52 weeks | Total hospital LOS |
| Secondary | Need for Intensive Care Unit (ICU) admission with/without mechanical ventilation during the index admission | Baseline (Day 1) to index admission discharge date | ICU admission during index admission |
| Secondary | Hospital survival post admission (index admission) | Baseline (Day 1) to index admission discharge date | Hospital survival for index admission |
| Secondary | Total OCS burden | Baseline (Day 1) to 52 weeks | Cumulative OCS dose |
| Secondary | Total number of exacerbations requiring emergency healthcare utilization (including ED, polyclinic visits, Specialist outpatient visits) | Baseline (Day 1) to 52 weeks | Total number of emergency healthcare utilization for exacerbations |
| Secondary | Pre/post bronchodilator Forced Expiratory Volume 1s (FEV1), FVC, FEV1/FVC at baseline and at 52 weeks | Change from baseline (Day 1) to 52 weeks | Change in Pre/post bronchodilator Forced Expiratory Volume 1s (FEV1), FVC, FEV1/FVC |
| Secondary | Blood eosinophil counts (serial measurement over 52 weeks) | Change from baseline (Day 1) to 52 weeks | Change in blood eosinophils |
| Secondary | GINA assessment of symptom control | Change from baseline (Day 1) to 52 weeks | Change in GINA assessment of symptom control ( Well controlled, Partly controlled or Uncontrolled) |
| Secondary | Asthma Control Questionnaire 7 (ACQ 7) | Change from baseline (Day 1) to 52 weeks | Change in Asthma Control Questionnaire 7 (ACQ 7) Scores range from 0-6( higher is worse). A score of 0.0-0.75 is classified as well-controlled asthma; 0.75-1.5 is a grey zone; and \>1.5 is poorly controlled asthma. The minimum clinically important difference is 0.5 |
| Secondary | St George's Respiratory Questionnaire (SGRQ) | Change from baseline (Day 1) to 52 weeks | Change in St George's Respiratory Questionnaire (SGRQ) The SGRQ total score is made up of 2 parts : Part 1 addresses the frequency of respiratory symptoms and Part 2 addresses the patient's current state. Data is entered into the calculator and scores will be generated ( 0 to 100). The lower the score, the better. |
| Other | Adverse Events | Change from baseline (Day 1) to 52 weeks | To evaluate adverse events, serious adverse events |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04617171/registered