Ignite Creation Date:
2024-05-06 @ 2:39 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04383262
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2020-05-01
Brief Title:
Oral Fosamprenavir-Sodium Alginate for LPR
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A 12-Week Randomized Double-Blind Placebo-Controlled Clinical Trial to Assess the Efficacy of Oral Fosamprenavir-Sodium Alginate Suspension for Laryngopharyngeal Reflux
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Laryngopharyngeal reflux LPR causes chronic cough throat clearing hoarseness and dysphagia and if left untreated can promote the development of laryngeal cancer More than 20 of the United Stated population suffer from LPR yet there is no effective medical therapy Proton pump inhibitors PPIs which inhibit gastric acid production but do not prevent reflux events continue to be prescribed for LPR despite their poor efficacy for this patient population high cost 26 billionyear and associated risks Pepsin detected in the airway of these patients and now known to cause laryngeal inflammation and promote disease independent of gastric acid is a key therapeutic target We report preclinical studies of select HIV inhibitors that bind to and inhibit pepsin and thus hold promise for the treatment of LPR In support a very low incidence of LPR was found in patients taking these drugs compared to the general population HIV inhibitors are ideal drugs to repurpose because they target a foreign virus Thus a repurposing approach can be used to safely perform proof of concept testing of the efficacy of a pepsin inhibitor for LPR The Specific Aim of this project is to perform a 12-week randomized double-blind placebo-controlled clinical trial to assess the efficacy of fosamprenavir-sodium alginateFOS-SA for LPR FOS-SA will be used at the FDA approved manufacturers recommended dose for HIV for 12 weeks in medically refractory patients with clinically diagnosed moderatesevere LPR and combined multi-channel intraluminal impedance - pH MII-pH confirmed laryngeal reflux events Routine clinical outcome measures for LPR Reflux Symptom Index Reflux Finding Score Voice Handicap Index will be documented pre- and post-treatment with Oral Fosamprenavir-Sodium Alginate for LPRn 52 and placebo n 52 Additional research measures will include repeat administration of a newly created Daily Symptom Reflex Diary as well as an intermittently distributed Patient Global Impression - Static Change scales Saliva will be collected pre-treatment for both pepsin protein analysis and kinetic activity assay to compare with clinical measures There is currently no effective medical therapy for LPR and pepsin is the key therapeutic target Identification of an FDA approved drug which inhibits pepsin allows for a clinical trial to determine efficacy using a faster and safer repurposing approach to address a significant gap
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None