NCT04710134CompletedPhase 4
Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma
Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma and Persistent Sputum Eosinophilia Despite Standard Dose Therapy
Source: ClinicalTrials.gov · Last updated 25 Jan 2024
Brief summary (registry, in English)
Dose escalation of reslizumab can ameliorate sputum eosinophilia in severe asthmatics who have persistent sputum eosinophilia despite treatment with reslizumab at the standard dose.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 8 Jan 2021
- Start date
- 10 Feb 2021
- Primary completion date
- 9 Jan 2024
- Lead sponsor
- McMaster University
- Diseases
- Asthma
- NCT number
- NCT04710134
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 10
- From 10 Feb 2021 to the primary completion date, 9 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently treated with another biologic agent (excluding denosumab for osteoporosis)
- Use of a systemic immunosuppressive or immunomodulatory agent within 6 months prior to study entry
- Suspected of abusing drugs or alcohol
Other illness
- Any comorbidity that the investigator believes is a contraindication including but not limited to any respiratory (e.g., chronic obstructive pulmonary disease, allergic bronchopulmonary aspergillosis, pulmonary fibrosis), cardiovascular (e.g., congestive cardiac failure, pulmonary hypertension), hematological, gastrointestinal, immunological, musculoskeletal, infectious, or neoplastic disease
Other
- Current smokers, ex-smokers with greater than 20 pack-year history or ex-smokers who have smoked within the past 6 months
- Use of anti-IL-5 (other than reslizumab) or anti-IgE mAb use within the past one month
- Pregnancy or lactation
Who the study is looking for
- Asthma confirmed within the past 2 years by:
- A ≥12% improvement in forced expiratory volume in 1 second (FEV1) after use of a beta agonist, or a methacholine challenge test showing a ≥20% reduction in FEV1 after a concentration of ≤8 mg/mL of methacholine
- Blood eosinophils ≥400 cells/µL and/or sputum eosinophils ≥3% (or presence of moderate-to-many free eosinophil granules) at the time of study enrollment
- Treated with an inhaled corticosteroid at a dose of ≥1500 µg of fluticasone propionate (or equivalent) and a long-acting beta agonist with or without oral corticosteroids
- Ability to provide informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Firestone Institute of Respiratory Health, St Joseph's Hospital Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.