Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD

Summary

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.

Eligibility

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.

Conditions2

Interventions2

Locations14 sites

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