Phase 2
Completed N=290
A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children
Source: ClinicalTrials.gov NCT03292588 ↗Enrolled (actual)
290
Serious AEs
2.1%
Results posted
Jun 2022
Primary outcomePrimary: Number of Asthma Exacerbations During the Treatment Period — 0.96; 1.30 Exacerbations during treatment — p=0.027
Summary
The purpose of this study is to see if treatment with a medication called Nucala® (mepolizumab), given along with standard asthma care, makes children less likely to have asthma attacks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Asthma Exacerbations During the Treatment Period |
0.96; 1.30 | 0.027 sig |
| SECONDARY Composite Asthma Severity Index (CASI) |
6.17; 6.45; 5.94; 6.01; 5.48; 5.99 | 0.290 |
| SECONDARY Participant Quality of Life Measured Using the Physician Global Assessment Tool |
58; 54; 27; 33; 22; 17 | 0.974 |
| SECONDARY Participant Quality of Life Measured Using the Patient Global Assessment, at Visit 14 |
82; 87; 27; 23; 11; 12 | 0.238 |
| SECONDARY Lung Function as Assessed by Spirometry |
0.747; 0.752; 0.755; 0.766; 0.758; 0.747 | 0.591 |
| SECONDARY Lung Function as Assessed by Impulse Oscillometry |
91.9; 92.3; 90.8; 94.2; 91.5; 89.9 | 0.816 |
| SECONDARY Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Did Not Fit the FDA-approved Dosing Table for Omalizumab Therapy. |
1.11; 1.31 | 0.458 |
| SECONDARY Rate of Exacerbations (Mepolizumab vs. Placebo) During the Treatment Period for Participants Who Fit the FDA-approved Dosing Table. |
0.87; 1.30 | 0.025 sig |
| SECONDARY Time to First Asthma Exacerbation |
241; 224 | 0.3587 |
| SECONDARY Number of Reported Adverse Events (AEs), Including Their Severity |
47; 39; 58; 51; 8; 3 | — |
| SECONDARY Number of Reported Adverse Events (AEs), Including Their Treatment Relatedness |
46; 26 | — |
| SECONDARY Number of Reported Serious Adverse Events (SAEs) Inclusive of Severity. Please Refer to the Adverse Event Tables for Specifics. |
0; 1; 3; 1; 0; 0 | — |
| SECONDARY Number of Reported Serious Adverse Events (SAEs) Inclusive of Treatment Relatedness. Please Refer to the Adverse Event Tables for Specifics. |
0; 1 | — |
Eligibility Criteria
Inclusion Criteria
Study applicant(s) that fulfill all of the inclusion criteria and none of the exclusion criteria are eligible for the study-
- Participant and/or parent guardian must be able to understand and provide informed consent and age-appropriate assent;
- Must have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the study's Manual of Procedures (MOP);
- Has had a diagnosis of asthma made >1 year prior to recruitment;
--Those who received an asthma diagnosis by a clinician ≤1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment.
- Has had ≥2 asthma exacerbations in the prior year (defined as a requirement for systemic corticosteroids and/or hospitalization);
- At Visit 0 (Screening), has the following requirement for asthma controller medication:
- For those ages 6 to 11 years, treatments with at least fluticasone 250 mcg dry powder inhaler (DPI) one puff twice daily or its equivalent and,
- For those ≥12 years of age, treatment with at least Advair 250/50 mcg dry powder inhaler (DPI), one puff twice daily or its equivalent.
- Has peripheral blood eosinophils ≥150 cells/µl obtained at Visit 0 (Screening) or in another Inner-City Asthma Consortium (ICAC) clinical research study within 6 months;
- Is able to perform spirometry at randomization (Visit for treatment assignment);
- Has documentation of current medical insurance with prescription coverage at randomization; and
- Has had varicella or the varicella vaccination.
Exclusion Criteria
Individual(s) who meets any of the following criteria are not eligible for enrollment or randomization-
- Is not able or willing to give written informed consent or comply with the study protocol;
- Has concurrent (existing) medical problems that would require systemic corticosteroids or other immunomodulator treatments during the study;
- Is currently receiving immunotherapy;
- Is currently receiving treatment with omalizumab or has had omalizumab treatment within 6 months prior to planned participant randomization to treatment assignment;
- Is currently requiring greater than fluticasone 500 mcg administered twice daily plus a long-acting beta agonist (LABA) one puff twice daily or its equivalent, and/or
--Individuals using oral corticosteroids daily or every other day for more than 14 days at the time of Visit 0 (Screening).
- Is currently pregnant or lactating, or plans to become pregnant during the time of study participation
--Note: Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral subcutaneous, mechanical, or surgical contraception).
- Has a known, pre-existing clinically important lung condition other than asthma;
- Has a current malignancy or previous history of cancer in remission for less than 12 months prior to randomization;
- Has known, pre-existing, unstable liver disease;
- Is a current smoker or has a smoking history of 10 or more pack years;
- Has a known immunodeficiency disease;
- Has other conditions that could lead to elevated eosinophils such as hypereosinophilic syndromes, including eosinophilic granulomatosis with polyangiitis;
- Has a known, active pre-existing parasitic infestation or is undergoing treatment for a parasitic infestation
--Note: Once the individual has been successfully treated, the interested study applicant may be reevaluated for study eligibility.
- Positive for use of investigational drugs within 4 weeks of randomization;
- Has a past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the study clinician,
- May pose additional risks from participation in this study,
- May interfere with the participant's ability to comply with study requirements, or
- May impact the quality or interpretation of the data obtained from t
Data sourced from ClinicalTrials.gov (NCT03292588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.