Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma
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|ClinicalTrials.gov Identifier: NCT04108377|
Recruitment Status : Recruiting
First Posted : September 30, 2019
Last Update Posted : May 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Roflumilast Drug: Placebo||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Roflumilast 500mcg by mouth, once daily, for 70 days (10 weeks).
Other Name: Daliresp
Placebo Comparator: Placebo
Placebo by mouth, once daily, for 70 days (10 weeks).
Sugar pill manufactured to mimic look of Roflumilast capsule
Other Name: Placebo for Roflumilast
- 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.
- Exhaled nitric oxide [ Time Frame: 3 months ]Determine where exhaled nitric oxide is lower in Group 1 vs Group 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
- 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?
- During the past 4 weeks, how often have you had shortness of breath?
- 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?
- In the past 4 weeks, how often have you used your rescue inhaler or nebulizer medication (such as albuterol)?
- How would you rate your asthma control during the past 4 weeks?
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 ClinicalTrials.gov identifier (NCT number): NCT04108377
|Contact: Nicholas Kenyon, MDfirstname.lastname@example.org|
|United States, California|
|Sacramento, California, United States, 95816|
|Contact: Nicholas Kenyon, MD 530-754-6935 email@example.com|
|Principal Investigator:||Nicholas Kenyon, MD||University of California, Davis|