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AsthmaPhase 2NCT04129931

PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

A Phase 2 study testing MCT, Clazakizumab and Broncho-Vaxom in people with Asthma, run by University of North Carolina, Chapel Hill at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to evaluate several interventions given to participants with severe asthma. Interventions are administered in a crossover manner with 16-week treatment periods followed by 8 to 16 week washout. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
MCT, Clazakizumab and Broncho-Vaxom
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
950 participants
Where
29 sitesUnited States
Study dates
19 Dec 2019to 19 Mar 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Started willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, age ≥ 12 years
  • No change in asthma medications for the past 2 months and use of medium or high dose inhaled corticosteroids (ICS) (defined by Table 1A) + an additional asthma controller/biologic (defined in Tables 1B and 1C). Participants entered into the run-in on medium dose ICS will be switched to high dose ICS. They must meet all entry criteria at the time of randomization including the criteria for uncontrolled asthma as assessed by symptoms during the two weeks prior to the randomization.
  • Baseline poor or uncontrolled asthma, defined as meeting at least one of the following:
  • Forced Expiratory Volume in one second (FEV1) <80% predicted (for adults ≥18) or FEV1<90% (pediatric participants <18) AND with 12% bronchodilator reversibility
Show all 14Show fewer
  • Poor symptom control - Asthma Control Questionnaire (ACQ-6) Score ≥1.5
  • ≥1 exacerbation defined as a documented burst of systemic corticosteroids (>3 days for adults and adolescents or >1 day for adolescents treated with dexamethasone) in prior year for those not receiving chronic oral corticosteriod (OCS) or an increase in >50% of baseline corticosteroid dose for ≥3 days in those receiving chronic OCS.
  • For patients on a biologic agent, at least one asthma exacerbation must have occurred at least 2 months after the initiation of the biologic agent. The definition of acceptable documentation for asthma exacerbations can be found in Section 6.5.3.
  • Evidence of asthma demonstrated by either bronchodilator reversibility or methacholine responsiveness either during the run-in or by historical evidence of either criterion if testing was performed under the same standards of the PrecISE Network at a PrecISE recruitment center. These criteria are defined as:
  • An increase in FEV1 ≥12% (and 200 ml) after up to 8 puffs of albuterol OR
  • Positive methacholine defined as provocative concentration causing a 20% decrease in FEV1 (PC20) ≤16 mg/ml, or provocative dose causing a 20% decline in FEV1 (PD20) ≤400 mcg/ml
  • Agreement to adhere to Lifestyle Considerations (see Section 5.4) throughout study duration
  • Owns a device compatible with the eDiary system used for CompEx, that is, an iOS 11+ device such as iPhone, iPad or iPod, or a smartphone or tablet running on Android 5.0+

Who cannot join

  • Current participation in an interventional trial (e.g. drugs, diets, etc.)
  • Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater)
  • Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways
  • Receiving one or more immune-modulating therapies for diseases other than asthma
  • Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®)
  • Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy
Show all 65Show fewer
  • Underwent a bronchial thermoplasty within the last two years
  • Born before 35 weeks of gestation
  • Uncontrolled hypertension, defined as systolic blood pressure >160 mm/Hg, or diastolic blood pressure >100 mm/Hg
  • History of malignancy except non-melanoma skin cancer within the last five years
  • History of smoking
  • If <30 years old: Smoked for ≥5 pack-years*
  • Can still be enrolled if <30, smoked <5 5 pack years and none in past year, and normal (negative) urine cotinine
  • If 30-39 years old: Smoked for ≥10 pack years
  • Can still be enrolled if ≥30, smoked <10 pack years and none in past year, provided participant demonstrates a normal (negative) urine cotinine
  • If ≥40 years old: Smoked ≥15 pack years
  • Can still be enrolled if ≥40 years old, smoked <15 pack years and none in the last year, provided participant demonstrates normal (negative) urine cotinine. Patients with a smoking history of ≥10 to <15 pack years will also need to demonstrate a normal Diffusing Capacity for Carbon Monoxide (DLCO) (>70% predicted) * Smoking equivalent pack years. One pack of cigarettes a day for 1 year is equivalent to:
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  • 1 cigar or pipe per day for 1 year
  • Smoked hookah or shisha =1 session per day for 1 year
  • Vaped e-cigarettes =0.5 mLs e-liquid per day for 1 year, or =1 cartridge/tank/pod per day for 1 year
  • 1 use of marijuana per day for 1 year
  • Active use of any inhalant >1 time per month in the past year
  • Active smoking of conventional tobacco, inhaling of marijuana or other drugs, or vaping of e-cigarettes or vape pods >1 time per month in the past year
  • Any form of tobacco qualifies, such as: 1 cigarette, 1 hookah or shisha sessions, 1 cigar, 1 pipe, etc.
  • Any electronic (e)-device included: e-cigarette e-cig, mod, vape pen, JUUL vaping device, e-cigar, e-hookah, e-pipe, vape pods, etc.
  • Any form of inhaled marijuana, including smoking marijuana leaves or inhaling tetrahydrocannabinol (THC) via e-cigarette or device
  • Substance abuse within the last year
  • Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation. Medically acceptable birth control/abstinence is defined as:
  • Career, lifestyle, or sexual orientation precludes intercourse with a male partner
  • For those in a monogamous relationship that precludes sexual activity with other partners, one of the sexual partners has been sterilized by vasectomy (in males) or hysterectomy and/or bilateral salpingo-oophorectomy (in females)
  • Use of highly effective methods of birth control defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Contraception should be used for at least 1 month prior to screening, throughout study participation and for an additional 16 weeks after the end of the final test treatment.
  • Pregnancy tests will be given to each female participant prior to study enrollment and at each clinic visit
  • Each male participant will agree to inform his sexual partner(s) of the potential for harm to an unborn child. If a sexual partner becomes pregnant while he is participating in the study, he will notify study staff within 24 hours of receiving medical confirmation. His partner will be advised to promptly notify her doctor
  • Any pregnancy (of a participant or a partner) will be monitored for adverse events with respect to pregnancy outcome until one month after birth.
  • Requirement for daily systemic corticosteroids above 10 mg of prednisone (or equivalent) per day for the past 2 months
  • Respiratory infection within 1 month of screening
  • Intubation for asthma in the last 12 months
  • Use of warfarin, current or last 30 days
  • Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study
  • Additional exclusions for specific interventions (and not for others) are listed in the Appendices I-VI, Section 5.2
  • Safety Exclusion Criteria:
  • Participants who meet the following criteria will be excluded from the study:
  • Hemoglobin <10 g/dL
  • Absolute Neutrophil Count (ANC) <1000/µl for black participants, <1500/µl for other participants
  • Lymphocytes <500/µl
  • Platelet count <100,000/µl
  • Alanine Transaminase (ALT)/Aspartate Aminotransferase (AST) >2x upper limits of normal (ULN)
  • Bilirubin ≥2x ULN
  • Estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 sq m
  • Positive Human Immunodeficiency Virus, Types 1 \& 2 (HIV 1\&2) Ab/Ag immunoassay followed by a confirmatory positive test (Geenius™ HIV-1/HIV-2 antibody differentiation immunoassay)
  • Positive Hepatitis B surface Ag (active infection) or Hepatitis B core total antibody (marker of past infection that could reactivate)
  • Positive Hepatitis C RNA test following positive Hepatitis C Antibody
  • EKG with significant clinical findings
  • A positive QuantiFERON-TB tuberculosis (TB) Gold test requires further screening. A participant may be included in PrecISE if at least one of the following criteria are met:
  • A chest radiograph (CXR) done within the last six months of the test that shows no evidence of active TB
  • A chest CT scan done within the last six months of the test that shows no evidence of active TB
  • Documentation of adequate treatment for latent TB In cases of an indeterminate QuantiFERON-TB test result, a second blood specimen must be drawn. A chest x-ray is not required if the participant has a negative QuantiFERON-TB Gold test.
  • Comorbid Conditions:
  • Comorbidities are commonly present in severe asthma. Specific questionnaires will be used to identify common comorbidities as follows:
  • Sleep apnea: STOP-BANG Questionnaire
  • GERD (GERD- Questionnaire)
  • VCD (Pittsburgh Vocal Cord Dysfunction (VCD) index)
  • Chronic Rhinitis Sinusitis (Sinonasal questionnaire-SNQ5)
  • Depression-Anxiety (Hospital anxiety and depression Scale: HADS) These questionnaires are best used as screening tools. As such they typically have high sensitivity but relatively low specificity. Many of their symptoms overlap with the symptoms reported by participants with asthma who do not suffer from these conditions. Therefore, participants who meet the established cut offs for these questionnaires will need to be evaluated by the investigator to consider the clinical significance of the positive questionnaire based on history and physical and available testing. The investigator will need to judge the presence, severity and control of a specific condition and determine if it is sufficiently controlled to keep the participant in the PrecISE protocol. If the comorbid condition(s) is/are not adequately controlled, the investigator may refer the participant for further evaluation/treatment, prior to enrollment in PrecISE. Rescreening is permitted (after at least four weeks) to determine if the participant is able to move forward in PrecISE once the comorbid condition(s) is/are under adequate control. It is expected that some of the participants may also have other conditions such as cardiovascular disease, diabetes and obesity. These should be evaluated clinically as part of the complete history and physical done at initial evaluation. Their inclusions should be based on the investigator clinical judgement in line with good clinical practice principles.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Illinois at Chicago

    Chicago, Illinois, 60608

  • Ann & Robert H. Lurie Children's Hospital

    Chicago, Illinois, 60611

  • Northwestern Universtiy

    Chicago, Illinois, 60611

  • Rush University

    Chicago, Illinois, 60612

  • University of Chicago

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • University Hospitals Rainbow Babies & Children's Hospital

    Cleveland, Ohio, 44106

  • National Jewish Health

    Denver, Colorado, 802006

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • University of Kansas

    Kansas City, Kansas, 66160

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06520

  • Mount Sinai

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10031

  • University of California Davis

    Sacramento, California, 95817

  • University of California San Diego: Airway Research & Clinical Trials Center

    San Diego, California, 92103

  • University of California San Diego: La Jolla Altman Clinical Translation Research Institute

    San Diego, California, 92121

  • University of California San Francisco

    San Francisco, California, 94143

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259

  • Washington University

    St Louis, Missouri, 63110

  • University of South Florida

    Tampa, Florida, 33613

  • University of Arizona Tucson

    Tucson, Arizona, 85724

  • Wake Forest University

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

The primary objective of this study is to evaluate several interventions given to participants with severe asthma. Interventions are administered in a crossover manner with 16-week treatment periods followed by 8 to 16 week washout.

Read the detailed description

PrecISE is a clinical study sponsored by the U.S. National Heart, Lung, and Blood Institute (NHLBI) to investigate several treatments for severe asthma. PrecISE will enroll 600 adults and teenagers (ages 12 years and older) with severe asthma who have symptoms that are not well-controlled on high dose of inhaled corticosteroids including those who have frequent asthma attacks. Each person who agrees to enroll in the PrecISE study will receive several treatments for research purposes based on their type of severe asthma.

The goal of PrecISE is to understand how to treat different types of severe asthma, by using precision medicine. Precision medicine is an approach that targets treatments to defined subgroups of patients who share similar characteristics, for example, patients with a certain genetic variation or patients with high number of blood eosinophils.

Researchers from over 30 locations across the US are involved in PrecISE.

Conditions
Asthma
Being tested
MCT, Clazakizumab, Broncho-Vaxom, Imatinib Mesylate, Cavosonstat
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MCTDrug

    Also called Breathe Better Diet (BBD)

    Mix 2-5 packets daily into liquid or food for 16 weeks.

  • ClazakizumabDrug

    Also called Anti-interleukin 6 monoclonal antibody (Anti-IL-6 mAb), BMS-945429, ALD518

    12.5 mg subcutaneous injection given once every 4 weeks for 16 weeks. Lab driven dose reductions will be made based on safety lab data. If criteria are met for dose reduction, the participant will be reduced to a 6.25 mg dose.

  • Broncho-VaxomDrug

    Also called OM-85 BV VEGETAL

    7 mg taken orally once a day, on an empty stomach, for 16 weeks

  • Imatinib MesylateDrug

    Also called Gleevec, Zoleta, Glivec, Ziatir

    Two 100 mg tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. If the drug is well tolerated, participants will titrate up to four 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks. Safety labs will be collected at each study visit to monitor the tolerability of each participant.

  • CavosonstatDrug

    Also called N91115

    50 mg capsule orally twice a day for 16 weeks.

  • PlaceboOther

    MCT Matching Placebo: MCT matching placebo packets. Mix 2-5 packets daily into liquid or food for 16 weeks.

    Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks for 16 weeks.

    Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks

    Imatinib Matching Placebo: Two 100 mg placebo tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Then four 100 mg placebo tablets once a day with a meal and an 8 oz glass of water for 14 weeks.

    Cavosonstat Matching Placebo: 50 mg matching placebo capsule orally twice a day for 16 weeks.

Study groups in NCT04129931
Study groupRoleWhat they receive
Medium Chain Triglycerides (MCT)ExperimentalParticipants in this arm will receive Medium Chain Triglycerides (MCT) powder packets (12.5 g each) daily for the 16 week treatment period. Participants are assigned one packet per 500 kilocalories required to maintain bodyweight; the target dose for each participant is between 2 and 5 packets daily. Participants will mix the packets of MCT supplement powder into liquids or semi-solid food. Participants will be randomized to the treatment sequence and will receive either the active MCT or the matching placebo first or vice versa.
Receives: Drug: MCT; Other: Placebo
ClazakizumabExperimentalParticipants randomized to this arm will receive a 12.5 mg dose of Clazakizumab via a subcutaneous injection at every study visit, every 4 weeks, during the 16-week treatment period at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Clazakizumab or the matching placebo first or vice versa.
Receives: Drug: Clazakizumab; Other: Placebo
Broncho-VaxomExperimentalParticipants randomized to this arm will receive 7 mg of Broncho-Vaxom once a day on an empty stomach for the 16-week treatment period duration at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Broncho-Vaxom or the matching placebo first or vice versa.
Receives: Drug: Broncho-Vaxom; Other: Placebo
ImatinibExperimentalParticipants randomized to this arm will take two 100 mg Imatinib tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Participants will then take four 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks. Participants will be randomized to the treatment sequence and will receive either the active Imatinib or the matching placebo first or vice versa.
Receives: Drug: Imatinib Mesylate; Other: Placebo
CavosonstatExperimentalParticipants randomized to this arm will take one 50 mg Cavosonstat capsule orally twice a day for the 16-week treatment period duration at any point in the study. Participants will be randomized to the treatment sequence and will receive either the active Cavosonstat or the matching placebo first or vice versa.
Receives: Drug: Cavosonstat; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Forced Expiratory Volume in One Second (FEV1) Percent Predicted

    Assessed prior to bronchodilator administration. Efficacy analyses will compare the end-of-period outcome values between test treatment and placebo.

    Measured: Measured at 16 weeks after the start of treatment.

  2. The Juniper Asthma Control Questionnaire (ACQ-6)

    Asthma symptom control is assessed via ACQ-6, the average score of these six items (range 0-6). The seven-point response scale: 0 = 'totally controlled' and 6 = 'severely uncontrolled'. Negative change from baseline values indicate improved asthma control. Efficacy analyses will compare the end-of-period outcome values between test treatment and placebo.

    Measured: Measured at 16 weeks after the start of treatment.

Secondary outcomes (7)

  1. CompEx Events Per Year

    Composite outcome with exacerbations (CompEx) is an outcome specific to asthma and chronic obstructive pulmonary disease (COPD) that combines clinically-relevant deteriorations with exacerbations. Deterioration events defined based on daily recordings of peak expiratory flow (PEF) morning/evening (L/min), reliever use morning/evening (doses), symptoms morning/evening (score 0-3) from twice-daily recordings. Participants are asked to describe their morning and evening symptoms using the following scale: 0-No symptoms to report, 3-I could not sleep because of my asthma/I could not perform my normal activities because of my asthma.

    Measured: Assessed over 16 weeks of treatment

  2. Forced Vital Capacity (FVC) Pre-bronchodilation

    Assessed prior to bronchodilator administration

    Measured: Measured at 16 weeks after the start of treatment.

  3. FEV1 % Predicted Post-bronchodilation

    Assessed after 4 puffs of bronchodilator administration

    Measured: Measured at 16 weeks after the start of treatment.

  4. Exacerbations

    Annualized rate of severe exacerbations during the 16-week treatment periods, modified intent-to-treat (mITT) population. An asthma exacerbation in PrecISE is defined as a worsening of asthma requiring the use of a systemic corticosteroid (at least 3 days of treatment) to prevent a serious outcome.

    Measured: Assessed over 16 weeks of treatment

  5. Number of Participants With At Least One Asthma-Free Day

    An asthma free day is a day where 1) there is no use of albuterol rescue (excluding the use of albuterol as pre-exercise treatment), 2) no daytime or nighttime asthma symptoms, 3) no peak expiratory flow of less than 80% of the predetermined reference value.

    Measured: Assessed over 16 weeks of treatment

  6. Number of Participants With At Least One Symptom-free Day

    A symptom free day is a day with no asthma symptoms (symptom score = 0) for both morning and evening daily diary entries.

    Measured: Assessed over 16 weeks of treatment

  7. Healthcare Utilization

    The combined total number of: asthma-specific Emergency Department visits, asthma-specific hospital admissions, and asthma-specific ICU admissions. The investigators report the number of participants with at least one asthma-specific Emergency Department visit, asthma-specific hospital admission, or asthma-specific ICU admission

    Measured: Assessed over 16 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2019
  2. Study start19 Dec 2019
  3. Primary completion19 Feb 2025
  4. Study completion19 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Treatment sequence will be randomly assigned as either test treatment followed by matching placebo or vice-versa.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
950 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129931
Sponsor's protocol ID
19-1681
Other IDs
5U24HL138998-03
Status last verified
Feb 2026
First submitted
15 Oct 2019
Last updated
1 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28877019

  • Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70. doi: 10.1056/NEJMra1510062. No abstract available.

    PubMed 28679092

  • 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.

    PubMed 28583396

  • 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.

    PubMed 27967215

  • Waljee AK, Rogers MA, Lin P, Singal AG, Stein JD, Marks RM, Ayanian JZ, Nallamothu BK. Short term use of oral corticosteroids and related harms among adults in the United States: population based cohort study. BMJ. 2017 Apr 12;357:j1415. doi: 10.1136/bmj.j1415.

    PubMed 28404617

  • Moore WC, Meyers DA, Wenzel SE, Teague WG, Li H, Li X, D'Agostino R Jr, Castro M, Curran-Everett D, Fitzpatrick AM, Gaston B, Jarjour NN, Sorkness R, Calhoun WJ, Chung KF, Comhair SA, Dweik RA, Israel E, Peters SP, Busse WW, Erzurum SC, Bleecker ER; National Heart, Lung, and Blood Institute's Severe Asthma Research Program. Identification of asthma phenotypes using cluster analysis in the Severe Asthma Research Program. Am J Respir Crit Care Med. 2010 Feb 15;181(4):315-23. doi: 10.1164/rccm.200906-0896OC. Epub 2009 Nov 5.

    PubMed 19892860

  • Peters SP, Kunselman SJ, Icitovic N, Moore WC, Pascual R, Ameredes BT, Boushey HA, Calhoun WJ, Castro M, Cherniack RM, Craig T, Denlinger L, Engle LL, DiMango EA, Fahy JV, Israel E, Jarjour N, Kazani SD, Kraft M, Lazarus SC, Lemanske RF Jr, Lugogo N, Martin RJ, Meyers DA, Ramsdell J, Sorkness CA, Sutherland ER, Szefler SJ, Wasserman SI, Walter MJ, Wechsler ME, Chinchilli VM, Bleecker ER; National Heart, Lung, and Blood Institute Asthma Clinical Research Network. Tiotropium bromide step-up therapy for adults with uncontrolled asthma. N Engl J Med. 2010 Oct 28;363(18):1715-26. doi: 10.1056/NEJMoa1008770. Epub 2010 Sep 19.

    PubMed 20979471

  • Lemanske RF Jr, Mauger DT, Sorkness CA, Jackson DJ, Boehmer SJ, Martinez FD, Strunk RC, Szefler SJ, Zeiger RS, Bacharier LB, Covar RA, Guilbert TW, Larsen G, Morgan WJ, Moss MH, Spahn JD, Taussig LM; Childhood Asthma Research and Education (CARE) Network of the National Heart, Lung, and Blood Institute. Step-up therapy for children with uncontrolled asthma receiving inhaled corticosteroids. N Engl J Med. 2010 Mar 18;362(11):975-85. doi: 10.1056/NEJMoa1001278. Epub 2010 Mar 2.

    PubMed 20197425

  • 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.

    PubMed 17140647

  • Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.

    PubMed 10146874

  • Fitzpatrick AM, Szefler SJ, Mauger DT, Phillips BR, Denlinger LC, Moore WC, Sorkness RL, Wenzel SE, Gergen PJ, Bleecker ER, Castro M, Erzurum SC, Fahy JV, Gaston BM, Israel E, Levy BD, Meyers DA, Teague WG, Bacharier LB, Ly NP, Phipatanakul W, Ross KR, Zein J, Jarjour NN. Development and initial validation of the Asthma Severity Scoring System (ASSESS). J Allergy Clin Immunol. 2020 Jan;145(1):127-139. doi: 10.1016/j.jaci.2019.09.018. Epub 2019 Oct 8.

    PubMed 31604088

  • 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.

    PubMed 26935973

  • 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.

    PubMed 24951239

  • Wise RA, Bartlett SJ, Brown ED, Castro M, Cohen R, Holbrook JT, Irvin CG, Rand CS, Sockrider MM, Sugar EA; American Lung Association Asthma Clinical Research Centers. Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers. J Allergy Clin Immunol. 2009 Sep;124(3):436-44, 444e1-8. doi: 10.1016/j.jaci.2009.05.041. Epub 2009 Jul 25.

    PubMed 19632710

  • 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.

    PubMed 26903687

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MCT, Clazakizumab and Broncho-Vaxom in people with Asthma, run by University of North Carolina, Chapel Hill at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 65 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Expiratory Volume in One Second (FEV1) Percent Predicted (time frame: Measured at 16 weeks after the start of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129931, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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