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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5
Roflumilast capsule
Sugar pill manufactured to mimic look of Roflumilast capsule
UC Davis
Sacramento, California, United States
Change in Beta 2 Agonist response from Baseline
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.
Time frame: 3 months
Exhaled nitric oxide
Determine where exhaled nitric oxide is lower in Group 1 vs Group 2
Time frame: 3 months
Asthma Control Test score
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?
Time frame: 3 months
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