Anti-Inflammatory Lipid Mediators in Asthma (ALMA)
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|ClinicalTrials.gov Identifier: NCT03680976|
Recruitment Status : Withdrawn (The study will not take place at the University of Pittsburgh)
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: CXA-10 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Anti-Inflammatory Lipid Mediators in Asthma|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
Experimental: 10-nitro-octadeca-9-enoic acid (CXA-10)
CXA-10 150 mg tablet taken orally once a day for 12 weeks
Liquid-filled capsule containing 150 mg CXA-10 in super refined olive oil.
Other Name: 10-nitro-octadeca-9-enoic acid
Placebo Comparator: Placebo
Placebo 150 mg tablet taken orally once a day for 12 weeks
Liquid-filled capsule containing olive oil manufactured to mimic CXA-10 150 mg capsule
- Change in airway responsiveness after treatment with CXA-10 using a methacholine challenge test [ Time Frame: 12 weeks ]Measured by the response to administration of methacholine. The PC20 is a calculated value of the amount of methacholine required to cause a 20% fall in the subject's FEV1.
- Treatment with CXA-10 compared to baseline: Change in the concentration of Nitrite/Nitrate (NO2/NO3). and NO2-Conjugated Linoleic Acid (CLA) in plasma and urine [ Time Frame: 12 weeks ]Measured using analysis of plasma and urine at baseline and after treatment with CXA-10.
- Treatment with CXA-10 compared to baseline: Characterization of the pharmacokinetic (PK) profile of CXA-10 in plasma and urine [ Time Frame: 12 weeks ]Measured using analysis of plasma and urine at baseline and after treatment with CXA-10.
- Treatment with CXA-10 compared to baseline: Changes in airway epithelial gene expression [ Time Frame: 12 weeks ]Measured using bronchial samples from the subjects randomized to undergo a bronchoscopy
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): NCT03680976
|United States, Pennsylvania|
|The University of Pittsburgh Asthma Institute at UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Sally E Wenzel, MD||The University of Pittsburgh|