for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
at UC Davis
study started
estimated completion
Principal Investigator
by Nicholas Kenyon, MD (ucdavis)



This study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo.

Official Title

Phosphodiesterase 4 Inhibitor, Roflumilast, Improves Beta Agonist Responsiveness Compared to Placebo in Low T2 Asthma Patients.


T2 low asthma is common in obese asthmatics. New evidence suggests that hyperinsulinemia and insulin resistance, both common in obesity, are associated with an increased risk of concurrent asthma.

Targeting Phosphodiesterase 4 inhibitors (PDE4) allows for examination of a mechanism potentially linking obesity and asthma as well as identification of readily available and safe options to treat hyperinsulinemic, overweight asthmatics.

It is hypothesized that obesity and hyperinsulinemia contribute to asthma by impairing β2 adrenoreceptor function and that this can be rescued the PDE4 inhibitor, roflumilast.


Asthma, Hyperinsulinemia, Phosphodiesterase 4 Inhibitor, Roflumilast


You can join if…

Open to people ages 18 years and up

  • Have a physician diagnosis of asthma.
  • Require treatment with moderate to high-dose >2500mcg/day of fluticasone or equivalent, or use of oral steroids

    Also two of the following:

  • Requirement for additional daily treatment with other controller medication
  • Daily Asthma symptoms
  • Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) < 70% and FEV1< 80% predicted
  • ≥1 urgent care visits/year
  • ≥3 oral steroid bursts/year
  • Near-fatal asthma event.
  • Exhaled Nitric oxide (FeNO)<30 ppb
  • Peripheral blood eosinophil count < 300 (x10-6/ul)
  • Obesity, BMI≥30

You CAN'T join if...

  • Less than 18 years of age
  • baseline FEV1 <30% predicted
  • pregnant or nursing women
  • current smokers or subject with >20 pack year history
  • any history of intolerance of, or reaction to, Roflumilast.
  • Prisoners
  • Patients with liver disease
  • Subjects with Hepatic impairment (contraindicated in moderate-to-severe liver impairment: Child-Pugh Score Class B/C) for example.
  • Patients with clinically significant psychiatric history (i.e., suicidality, etc.) and psychiatric illness
  • Patients using strong CYP 450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin).


  • UC Davis accepting new patients
    Sacramento California 95816 United States

Lead Scientist at University of California Health

  • Nicholas Kenyon, MD (ucdavis)
    Professor, Pulmonary, Critical Care, and Sleep Medicine, School of Medicine. Authored (or co-authored) 140 research publications


accepting new patients
Start Date
Completion Date
University of California, Davis
Learn more or sign up for the study here!
Phase 1 Asthma Research Study
Study Type
Expecting 24 study participants
Last Updated