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
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
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?
| Wisconsin | 25.0% |
| California | 25.0% |
| North Carolina | 25.0% |
| Other | 25.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 50.0% |
| Met criteria | 50.0% |
What site did they apply to?
| University Hospitals Rainbow Babies & Children's Hospital | 100.0% |
References
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- Phipatanakul, Wanda, David T. Mauger, Ronald L. Sorkness, Jonathan M. Gaffin, Fernando Holguin, Prescott G. Woodruff, Ngoc P. Ly, et al.. 2017. “Effects of Age and Disease Severity on Systemic Corticosteroid Responses in Asthma”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201607-1453oc.
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- Israel E, Reddel HK. Severe and Difficult-to-Treat Asthma in Adults. N Engl J Med. 2017 Sep 7;377(10):965-976. doi: 10.1056/NEJMra1608969. No abstract available.
- Zhu R, Zeng D, Kosorok MR. Reinforcement Learning Trees. J Am Stat Assoc. 2015;110(512):1770-1784. doi: 10.1080/01621459.2015.1036994. Epub 2015 Apr 16.
- de Wit HM, Te Groen M, Rovers MM, Tack CJ. The placebo response of injectable GLP-1 receptor agonists vs. oral DPP-4 inhibitors and SGLT-2 inhibitors: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016 Jul;82(1):301-14. doi: 10.1111/bcp.12925. Epub 2016 Apr 22.
- Fuhlbrigge AL, Bengtsson T, Peterson S, Jauhiainen A, Eriksson G, Da Silva CA, Johnson A, Sethi T, Locantore N, Tal-Singer R, Fageras M. A novel endpoint for exacerbations in asthma to accelerate clinical development: a post-hoc analysis of randomised controlled trials. Lancet Respir Med. 2017 Jul;5(7):577-590. doi: 10.1016/S2213-2600(17)30218-7. Epub 2017 Jun 2.
- Sorkness CA, Lemanske RF Jr, Mauger DT, Boehmer SJ, Chinchilli VM, Martinez FD, Strunk RC, Szefler SJ, Zeiger RS, Bacharier LB, Bloomberg GR, Covar RA, Guilbert TW, Heldt G, Larsen G, Mellon MH, Morgan WJ, Moss MH, Spahn JD, Taussig LM; Childhood Asthma Research and Education Network of the National Heart, Lung, and Blood Institute. Long-term comparison of 3 controller regimens for mild-moderate persistent childhood asthma: the Pediatric Asthma Controller Trial. J Allergy Clin Immunol. 2007 Jan;119(1):64-72. doi: 10.1016/j.jaci.2006.09.042. Epub 2006 Nov 30. Erratum In: J Allergy Clin Immunol. 2007 Aug;120(2):285.
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- Phipatanakul W, Mauger DT, Sorkness RL, Gaffin JM, Holguin F, Woodruff PG, Ly NP, Bacharier LB, Bhakta NR, Moore WC, Bleecker ER, Hastie AT, Meyers DA, Castro M, Fahy JV, Fitzpatrick AM, Gaston BM, Jarjour NN, Levy BD, Peters SP, Teague WG, Fajt M, Wenzel SE, Erzurum SC, Israel E; Severe Asthma Research Program. Effects of Age and Disease Severity on Systemic Corticosteroid Responses in Asthma. Am J Respir Crit Care Med. 2017 Jun 1;195(11):1439-1448. doi: 10.1164/rccm.201607-1453OC. Erratum In: Am J Respir Crit Care Med. 2018 Apr 1;197(7):970-971.
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- Dutile S, Kaptchuk TJ, Wechsler ME. The placebo effect in asthma. Curr Allergy Asthma Rep. 2014 Aug;14(8):456. doi: 10.1007/s11882-014-0456-2.
- Zhao Y, Zeng D, Rush AJ, Kosorok MR. Estimating Individualized Treatment Rules Using Outcome Weighted Learning. J Am Stat Assoc. 2012 Sep 1;107(449):1106-1118. doi: 10.1080/01621459.2012.695674.
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- 2019. "PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04129931.
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