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Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04108377
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : May 11, 2021
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Roflumilast Drug: Placebo Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phosphodiesterase 4 Inhibitor, Roflumilast, Improves Beta Agonist Responsiveness Compared to Placebo in Low T2 Asthma Patients.
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Roflumilast

Arm Intervention/treatment
Experimental: Roflumilast
Roflumilast 500mcg by mouth, once daily, for 70 days (10 weeks).
Drug: Roflumilast
Roflumilast capsule
Other Name: Daliresp

Placebo Comparator: Placebo
Placebo by mouth, once daily, for 70 days (10 weeks).
Drug: Placebo
Sugar pill manufactured to mimic look of Roflumilast capsule
Other Name: Placebo for Roflumilast

Primary Outcome Measures :
  1. Change in Beta 2 Agonist response from Baseline [ Time Frame: 3 months ]
    Determine whether β2 receptor responsiveness is improved in response to albuterol in Group 1 (Roflumilast) patients compared to Group 2 (Placebo) patients at the study entry.

Secondary Outcome Measures :
  1. Exhaled nitric oxide [ Time Frame: 3 months ]
    Determine where exhaled nitric oxide is lower in Group 1 vs Group 2

  2. Asthma Control Test score [ Time Frame: 3 months ]

    The Asthma Control Test (TM © 2002 by QualityMetric) is a validated instrument to measure symptom control in asthma patients. There are 5 questions each with a score of 1-5 (25 total points). Poor asthma control is considered with a score less than 20 out of 25.

    Determine whether Asthma Control Test score is improved in Group 1 vs Group 2

    Asthma Control TestTM

    1. In the past 4 weeks, how much of the time did your asthma keep you from getting as much done at work, school or at home?
    2. During the past 4 weeks, how often have you had shortness of breath?
    3. During the past 4 weeks, how often did your asthma symptoms (wheezing, coughing, shortness of breath, chest tightness or pain) wake you up at night or earlier than usual in the morning?
    4. In the past 4 weeks, how often have you used your rescue inhaler or nebulizer medication (such as albuterol)?
    5. How would you rate your asthma control during the past 4 weeks?

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04108377

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Contact: Nicholas Kenyon, MD 530-754-6935

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United States, California
UC Davis Recruiting
Sacramento, California, United States, 95816
Contact: Nicholas Kenyon, MD    530-754-6935   
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Nicholas Kenyon, MD University of California, Davis
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Responsible Party: University of California, Davis Identifier: NCT04108377    
Other Study ID Numbers: 1406843
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, Davis:
Phosphodiesterase 4 Inhibitor
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases