MCT for Asthma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
AsthmaMCT - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing different interventions for severe asthma sufferers. Each person tries a different intervention for 16 weeks, followed by a break, then tries another one.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Assessed over 16 weeks of treatment

Week 16
Asthma free days
CompEx events
Healthcare utilization
Symptom free days
Time to first exacerbation
Week 16
FEV1 post-bronchodilation
Forced Expiratory Volume in one second (FEV1) percent predicted
Forced Vital Capacity (FVC) pre-bronchodilation
The Juniper Asthma Control Questionnaire (ACQ-6)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

Clazakizumab
1 of 5
Cavosonstat
1 of 5
Medium Chain Triglycerides (MCT)
1 of 5
Broncho-Vaxom
1 of 5
Imatinib
1 of 5

Experimental Treatment

600 Total Participants · 5 Treatment Groups

Primary Treatment: MCT · Has Placebo Group · Phase 2

ClazakizumabExperimental Group · 2 Interventions: Placebo, Clazakizumab · Intervention Types: Other, Drug
CavosonstatExperimental Group · 2 Interventions: Cavosonstat, Placebo · Intervention Types: Drug, Other
Medium Chain Triglycerides (MCT)Experimental Group · 2 Interventions: MCT, Placebo · Intervention Types: Drug, Other
Broncho-VaxomExperimental Group · 2 Interventions: Broncho-Vaxom, Placebo · Intervention Types: Drug, Other
ImatinibExperimental Group · 2 Interventions: Imatinib Mesylate, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medium-chain triglycerides
FDA approved
Cavosonstat
Not yet FDA approved
Imatinib
FDA approved
OM85
Not yet FDA approved
Clazakizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: assessed over 16 weeks of treatment

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,371 Previous Clinical Trials
3,930,084 Total Patients Enrolled
30 Trials studying Asthma
1,628 Patients Enrolled for Asthma
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,598 Previous Clinical Trials
46,955,834 Total Patients Enrolled
262 Trials studying Asthma
108,494 Patients Enrolled for Asthma
Anastasia IvanovaPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Eligibility Criteria

Age Any Age · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
I am willing to comply with all study procedures and be available for the duration of the study.
A person has an FEV1 (force expiratory volume in one second) of less than 80% predicted for adults aged 18 or older, or less than 90% for pediatric participants aged 18 or younger, and has a 12% bronchodilator reversal.
Asthma exacerbations that occur more than two months after the start of a biologic agent are acceptable forms of documentation for asthma.
Each participant must agree to adhere to the lifestyle considerations listed in Section 5.4 throughout the duration of the study.
An exacerbation is defined as a documented burst of systemic corticosteroids (greater than or equal to 3 days for adults and adolescents, or greater than or equal to 1 day for adolescents treated with dexamethasone) in the prior year for those not receiving chronic OCS or an increase in greater than 50% of baseline corticosteroid dose for greater than or equal to 3 days in those receiving chronic OCS.
You are on a stable regimen of asthma medications.
is a required component of all studies The requirement for a signed and dated informed consent form is a component of all studies.
You currently have unconrolled asthma, or worsening asthma & attacks.
You are over the age of 12
You have severe asthma as defined by commonly accepted guidelines
You are not pregnant and not breastfeeding.

Who else is applying?

What state do they live in?
Wisconsin25.0%
California25.0%
North Carolina25.0%
Other25.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%
What site did they apply to?
University Hospitals Rainbow Babies & Children's Hospital100.0%
References