Asthma
Conditions
Keywords
Hyperinsulinemia, Phosphodiesterase 4 Inhibitor
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.
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.
Interventions
DRUGRoflumilast
Roflumilast capsule
DRUGPlacebo
Sugar pill manufactured to mimic look of Roflumilast capsule
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Beta 2 Agonist response from Baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Exhaled nitric oxide | 3 months | Determine where exhaled nitric oxide is lower in Group 1 vs Group 2 |
| Asthma Control Test score | 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? |
Countries
United States
Outcome results
None listed