Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD
Purpose
Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.
Condition
- Rhinovirus Infection
Eligibility
- Eligible Ages
- Between 40 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Sign informed consent for study participation and medical records release (if needed). Male or female age ≥40 years and ≤85 years at the time of signing the informed consent at Screening. If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective form of contraception at the time of randomization until 30 days (females) or 90 days (males) after the last dose. Female participants may not use hormonal birth control as a sole method. Participants will be asked to commit to this criterion at screening even though it does not need to be implemented until treatment is received. Confirmed diagnosis of COPD, defined as chronic cough, sputum production, and/or dyspnea with airflow obstruction which is not fully reversible (that is, post bronchodilator FEV1/FVC ratio <0.70 and post bronchodilator FEV1 ≥20% and <80% of predicted normal value). History of AECOPD with at least 1 documented AECOPD within 1 year of Screening. AECOPD is defined as an event characterized by dyspnea and/or cough and increased sputum purulence/change in sputum color that worsens over several days, and requires at least one of the following for 2 days 1. Increase frequency or dose of beta agonist(s), oxygen, breathing treatments or chronic COPD medications (Mild Exacerbation) 2. Use of oral or systemic steroids (Moderate Exacerbation), or 3. Use of Antibiotics (Moderate Exacerbation), or 4. Emergency room visit or hospitalization (Severe Exacerbation). CAT score ≥10 at screening. Able to comply with all study requirements, including the use of a mobile application to complete daily PROs, perform nasal swabs at home, and able to assess when they have cold symptoms. Interacts with people at least twice a week without a mask (e.g., grocery shopping, dinner with grandchildren, eating at a restaurant, going to the movies, etc.) or are living in a multigenerational home.
Exclusion Criteria
(At Randomization only): If on stable COPD maintenance therapy this should be stable for at least 2 months prior to randomization. Changes allowed with Sponsor approval (i.e., change within same class due to financial considerations and clinically stable). Clinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization. The presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test. To be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dosing Group 1 VPV 1000 mg |
The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 1,000 mg VPV will be taken at home the following morning with food. The subsequent 1,000 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses. |
|
|
Experimental Dosing Group 2 VPV 500 mg |
The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 500 mg VPV will be taken at home the following morning with food. The subsequent 500 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses. |
|
|
Placebo Comparator Dosing Group 3 Placebo |
The first dose of placebo will be taken at the study site with food once the Day 1 visit is completed. The second dose of placebo will be taken at home the following morning with food. The subsequent placebo doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses |
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Recruiting Locations
Tempe, Arizona 85281
AMR Clinical - Tempe
Newport Beach, California 92663
NewportNativeMD, Inc.
San Diego, California 92120
Apex Clinical Research
Miami Lakes, Florida 33014
VM Clintrials
Snellville, Georgia 30078
Accelerated Clinical Trials, LLC
Valparaiso, Indiana 46383
Velocity Clinical Research - Valparaiso
Lutherville, Maryland 21093
Patient First Clinical Trials (PFCTRIALS)
Brooklyn, New York 11226
Brooklyn Clinical Research
Kings Mountain, North Carolina 28086
CRC Kings Mountain
Columbus, Ohio 43215
Remington-Davis, Inc.
DuBois, Pennsylvania 15801
Clinical Research Associates of Central PA, LLC l
Pittsburgh, Pennsylvania 15423
Preferred Primary Care Physicians - St. Clair
Anderson, South Carolina 29621
Velocity Clinical Research - Anderson
Rock Hill, South Carolina 29732
Clinical Research of Rock Hill
More Details
- Status
- Recruiting
- Sponsor
- Altesa Biosciences, Inc.