A Study of the Experimental Medicine Roflumilast for Severe Asthma

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: asthma, severe asthma, obesity
Type: Drug study, Phase 1
Target:
24 Participants
Investigator:
Description
This is a research study that will test the experimental drug Roflumilast. The study team hopes Roflumilast can improve asthma symptoms and lung function.

We hope to understand the effects of Daliresp™, a.k.a. Roflumilast, on improving the response to asthma in low T2, obese asthmatics.

We will test your blood, breath, before and after taking the medication, for evidence of improvement in your asthma care.
This study requires

If you decide to take part in this study, you will take part in two study visits. You will be asked about your height and weight. The first time we will ask you some standard questions to make sure you are fit and able to breathe deeply. For the lung health measurements, you will be asked to blow forcefully into a hand held (small) instrument (an office spirometer) that measures the air you exhale. You will also be asked to have your blood drawn in two small tubes. You will fill out a brief questionnaire.

If you decide to volunteer, you will be one of 24 adult subjects who will participate. The study will take up to 1-hour of your time per study visit, and requires a total of 2 study visits over a 90 day period. In addition you will be asked to perform and record daily peak flow measurement (morning and night), which will take less than 5 minutes a day.

At each visit, a brief history and physical exam will be performed. If you qualify and agree to participate you will be randomly (coin toss) assigned to one of two groups: a group that takes the placebo, and a group that takes the Roflumilast. This is a blinded study, so neither you nor the investigators will know what you are taking until the study has been completed.

You will have 2 testing sessions when you undergo testing of your blood, breath, and sputum. The first session occurs before you start taking the pills.

Who can participate

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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).
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $100.00, ($50 for each of the two visits) for your time and effort.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 90 days.
Recruitment period
From Aug. 21, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Asthma

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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