Oral Fosamprenavir-Sodium Alginate for LPR

Launched by MEDICAL COLLEGE OF WISCONSIN · May 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for a condition called laryngopharyngeal reflux (LPR), which can cause symptoms like chronic cough, throat clearing, and hoarseness. The trial will test a drug called fosamprenavir-sodium alginate (FOS-SA), which is already approved for treating HIV. Researchers believe that this drug can help reduce the inflammation caused by a protein called pepsin, which may play a role in LPR. The trial will last for 12 weeks and will involve 104 participants who have moderate to severe LPR and haven’t found relief with standard treatments.

To be eligible for the study, participants must be at least 18 years old, have a confirmed diagnosis of LPR, and have symptoms that have not improved after trying other treatments. Participants will be randomly assigned to receive either the study drug or a placebo (a dummy treatment with no active ingredients) and will be asked to keep track of their symptoms during the study. Those who join will have regular check-ins and will need to provide saliva samples for research purposes. This trial is a promising step towards finding a more effective therapy for LPR, an issue that affects many people but currently lacks good treatment options.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Clinical diagnosis of LPR
• • Age ≥ 18 years
• • RSI \> 13
• • RFS \> 7
• • Documented LPR by MII-pH testing (\> 1 proximal event)
• • Failed 3 month bid PPI therapy
• • Attending laryngology clinic with study providers, and having flexible laryngoscopy and MII-pH testing per routine clinical care with a minimum of three months between clinic visits (standard practice)
• • Patients must be deemed able to comply with the saliva sample collection, treatment plan, and follow-up schedule
• • Patients must provide study-specific informed consent prior to study entry
• • Hepatic Function Panel must be within normal limits
• • Results from V1 safety labs must all be within normal limits
• • Additionally, subjects must have the following
• • Ownership of an electronic device meeting minimum hardware and software specifications required to conduct the DRSD, PGI-S, and PGI-C
• • Internet access
• • A valid email address for notifications
• • Agreement not to turn off notifications related to the study
• • Exclusion Criteria
• • Age ≥ 65 years
• • Pregnant (or plan to be) and nursing mothers
• • Women of child-bearing potential not willing to comply with contraceptive requirements during the study treatment and for 1 week following the last dose of study drug.
• • Definition of women of child-bearing potential
• • Non-post-menopausal female, who has not had a bilateral oophorectomy or medically documented ovarian failure. A subject may be considered to be post-menopausal when there is either:
• • twelve (12) months of spontaneous amenorrhea or;
• • six (6) months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL or;
• • six (6) weeks postsurgical bilateral oophorectomy with or without hysterectomy. A female who has had a tubal ligation sterilization or hysterectomy would not be considered to be of reproductive potential unless participating in activities of reproductive potential other than heterosexual intercourse (e.g., egg donation, participation in in vitro fertilization).
• • Contraceptive requirements Fosamprenavir may decrease the effectiveness of combined hormonal contraception through significant CYP3A4 induction of estrogen. If subjects' preferred choice of contraception is combined hormonal contraception, subjects must also agree to use a second method of contraception (condom + spermicide) during study drug treatment.
• Other acceptable highly effective forms of contraception include:
• • Medroxyprogesterone acetate injectable
• • Intrauterine Device
• • Female Sterilization
• • Male Sterilization
• • Currently being treated with another investigational medical device and/or drug
• • A history of gastric or esophageal surgery
• • GI disease that might interfere symptom questionnaire, e.g. IBD
• • A history of laryngeal or neck surgery including thyroidectomy and laryngomicroscopic surgery
• • Suspected esophageal cancer
• • Nasopharyngeal cancer
• • Previously undergone anti-reflux surgery
• • Polypharmacy (five or more concurrent medications due to comorbidities)
• • Any contraindications to FOS
• • Anticipated poor understanding or compliance of the study protocol
• • History of hepatic impairment
• • Sulfa Allergy
• • Hemophilia
• • Active tuberculosis (TB) or history of active TB.
• • History of latent TB (e.g., positive QuantiFERON-TB test) without history of active TB unless the subject has completed a documented course of prophylactic treatment.
• • History of human immunodeficiency virus (HIV) infection or positive for HIV
• • Seropositive for hepatitis B surface antigen (HBsAg).
• • Hepatitis C virus (HCV) RNA positive.