Clinical Studies

The Division of Pulmonary & Critical Care Medicine conducts and participates in a number of clinical studies in the area of Asthma.

Characterizations of Adults for Asthma Microbiome Research Studies (CAARS)

A prospective, observational, two-visit study in which approximately 200 subjects will be enrolled, including healthy controls, atopic controls without asthma, and patients with asthma. Among asthmatics, 2/3 will be on regular inhaled corticosteroid therapy and 1/3 will not be taking inhaled corticosteroids. Subjects who meet study criteria will undergo phenotypic characterization in multiple domains, including evaluation of lung function, assessments of asthma/allergy history, asthma triggers, asthma symptom control, environmental microbial exposures, and dietary intake. Oral rinse, sputum, stool, urine, and blood specimens will be collected for microbiome-related analyses. The overall goal is to enroll a cohort of well-characterized asthmatic and non-asthmatic control subjects to enable mechanism-oriented studies of how members of the airway microbiota and possibly also gut microbiota influence phenotypes of adult asthma.

Inclusion Criteria:

  • Men or women, age 18-75 with or without current asthma
  • Cigarette smoking history <30 pack-years and no current use of other smoked products or recreational drugs
  • Not pregnant or breastfeeding
  • No other lung disease, major medical condition, or immunosuppressant use except corticosteroids or antibody-based biologics used to treat asthma
  • For asthmatics, history of asthma symptoms within the last 2 years and on stable asthma medications

View study on the UM Health Research website. 

Microbiome Markers of Adult Asthma Phenotype (MICROMAAP) – COMING SOON

A longitudinal extension of CAARS to follow participants in a 12-month observational study with an optional one-time bronchoscopy sub-study. The overall goal is to follow a cohort of well-characterized asthmatic and non-asthmatic subjects to investigate relationships between microbiome signatures, host immune response patterns, and clinical features of asthma, spanning periods of potential variability in these parameters over different seasons.

Inclusion Criteria:

  • Men or women, age 18-75
  • Enrolled in the CAARS study
  • Cigarette smoking history <30 pack-years and no current use of other smoked products or recreational drugs
  • Not pregnant or breastfeeding
  • No other lung disease, major medical condition, or immunosuppressant use except corticosteroids or antibody-based biologics used to treat asthma

Chronic Refractory Cough Cohort Study (COCO)

This cohort study of 100 patients with chronic refractory cough will be used to determine: (1) the statistical and psychometric properties of the cough questionnaires to be used as outcomes in a larger trial; (2) establish whether it is feasible to identify and accrue such patients in a trial; and (3) evaluate whether zinc deficiency is prevalent in patients with chronic refractory cough.

Inclusion Criteria:

  • Men or women age 18 or older
  • Chronic cough for more than 3 months
  • No upper or lower respiratory infection within 4 weeks
  • Either
    • Negative evaluation for:
      • Asthma: No symptoms of disease or no evidence of asthma based on spirometry and/or Methacholine Challenge Test
      • GERD: No symptoms of acid reflux disease or negative pH probe
      • Rhinosinusitis/upper airway cough
    • OR
    • Cough persists despite treatment for the following:
      • Asthma treated with at least 8 weeks of treatment with a medium dose inhaled corticosteroids or oral corticosteroids
      • GERD treated for at least 8 weeks with either a proton pump inhibitor (PPI) or H2 blocker
      • Upper airway disease, postnasal drip or sinusitis treated for at least 8 weeks with nasal steroids and/or antihistamines
  • Non-smoker; defined as
    • no smoking of any substance (e.g., tobacco, e-cigarette, marijuana) in the past 6 months and
    • less than 20 pack-year smoking history
  • Chest x-ray or CT scan in the past 12 months; negative for parenchymal lung diseases (such as interstitial lung disease, idiopathic pulmonary fibrosis, pneumonia, or TB) and negative for lung cancer
  • Cough VAS score of 15 or higher (for overall cough)
  • Informed consent

APR Registry

To develop a registry of patients with airways disease within the American Lung Association Airways Clinical Research Network (ALA-ACRC).

All patients contacted by the participating clinics with a physician diagnosis of asthma, COPD or ACOS can be enrolled, regardless of whether they are enrolled in individual study protocols of the ALA-ACRC network. Males and females of all ages will be eligible.

AstraZeneca ANDHI Study – COMING SOON

A multicenter, randomized, double-bind, parallel group, placebo-controlled, phase 3b study to evaluate the safety and efficacy of benralizumab 30mg subcutaneous in patients with severe asthma uncontrolled on standard of care treatment. Subjects will be randomized to receive repeated dosing of benralizumab 30mg subcutaneous or matching placebo for 24 weeks on top of standard of care asthma therapy.

Inclusion Criteria:

  • Male or female, age 18-75 with a history of physician-documented asthma requiring treatment with medium-to-high dose ICS plus asthma controller for at least 12 months prior to visit 1
  • Documented current treatment with high daily doses of ICS plus at least one other asthma controller for at least 3 months prior to visit 1
  • History of at least 2 asthma exacerbations while on ICs plus another asthma controller that required treatment with systemic corticosteroids in the last 12 months prior to visit 1
  • ACQ6 score ≥ 1.5 at visit 1
  • Screening pre-BD FEV1 <80% predicted at visit 2
  • Evidence of asthma as documented by airway reversibility (FEV1 ≥12% change) demonstrated at visit 2 or visit 3
  • Peripheral blood eosinophil count of ≥ 300 cells/uL as assessed by central laboratory at visit 1 or visit 2
  • Weight ≥ 40 kg

GSK 207597: A Study to Evaluate the Effect of GSK3772847 in Patients with Severe Asthma – COMING SOON

A randomized, double-blind, parallel group, multicenter, stratified study evaluating the efficacy and safety of repeat doses of GSK3772847 compared with placebo in participants with severe asthma.

Inclusion Criteria:

  • Male or female, age 18 and over with a documented diagnosis of severe asthma whose asthma has been managed with regular treatment of high dose ICS and LABA for at least 4 months. Additional therapy with a leukotriene receptor antagonist is permissible
  • Airway reversibility of at least 12% and 200mL in FEV1 at screening or documented reversibility prior to screening or documented history of bronchial hyperreactivity from a bronchoprovocation study (e.g. methacholine challenge) prior to screening
  • ACQ6 score ≥ 1.5 at screening
  • At least one asthma exacerbation within 12 months prior to screening that required treatment with systemic corticosteroids and/or hospitalization

GSK 204710 – COMING SOON

A multinational, single arm, observational study to evaluate the real-world effectiveness and pattern of use of mepolizumab in patients with severe eosinophilic asthma. This is a real world study following those whose physician has made the decision to initiate NUCALA treatment and have agreed to consent to observation. The assignment of a patient to therapy is not decided in advance by the study protocol but is determined by the usual practice of medicine and the decision to prescribe NUCALA is dissociated from the decision to include the patient in the study. No visits are scheduled for the study. Data will be collected at the patients’ usual healthcare visits.

Inclusion Criteria:

  • Male or female, age 18 and over with a current clinical diagnosis of asthma
  • Physician decision to initiate treatment with NUCALA
  • Available access to medical records for at least 12 months prior to enrollment
  • Enrolled in an Anthem affiliated health plan (preferred)

 
For more information regarding the above clinical studies, please send an email to asthma-research@med.umich.edu or visit: