RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection (NCT06149494) | Clinical Trial Compass
CompletedPhase 2
RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection
United Kingdom52 participantsStarted 2023-11-20
Plain-language summary
Vapendavir (VPV) is a drug being developed to treat human rhinovirus (RV) infection, one virus responsible for the common cold. Vapendavir prevents the virus from entering cells and making more infectious copies of itself. A study is being planned to investigate VPV in patients with chronic obstructive pulmonary disease (COPD, a lung disease making it difficult to breathe) who develop a rhinoviral infection; however, VPV has not been approved for use in treating any indication (disease) by the FDA or any other global regulatory agency. Therefore, VPV is considered investigational, and the study doctor is conducting this investigational research study. Safety will be monitored throughout the entire study.
Who can participate
Age range40 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female age ≥40 years and ≤75 years at the time of signing the informed consent form.
✓. If sexually active and/or of child-bearing potential (both females and males), must agree to use a highly effective forms of contraception ≥ 28 days prior to the first dose (females), during the study period (both males and females) and for 30 days (females) or 90 days (males) after the last dose. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Highly effective contraception is defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly.
✓. Confirmed diagnosis of Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) stage II COPD as defined by % predicted Forced expiratory volume in 1 second (FEV1) ≥50% and FEV1/Forced vital capacity (FVC) \<70%.
✓. History of acute exacerbations of COPD as defined by the participant answering "yes" to the question "do your COPD symptoms get noticeably worse when you catch a cold?"
✓
What they're measuring
1
Peak change from baseline
Timeframe: From Baseline Visit through Follow-Up Visit, up to 7 weeks
. If on maintenance therapy, be medically stable for at least 2 months prior to enrolment.
✓. Clinically stable with no exacerbations within 2 months prior to enrolment.
✓. Ability to understand and give informed consent.
Exclusion criteria
✕. Participants with other causes of chronic airflow limitation:
✕. Including but not limited to: Asthma (mixed COPD and asthma is acceptable); cystic fibrosis (CF); bronchiolitis obliterans; and fibrosis such as tuberculosis (TB), idiopathic pulmonary fibrosis (IPF), or other major respiratory diagnosis (e.g., pneumonia, aspergillosis), etc.
✕. Non-CF bronchiectasis
✕. Any disorder, for example, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric impairment that is not medically stable, or other major physical impairment that is not considered by the investigator medically stable/controlled.
✕. Prescription or over-the-counter medications or herbal products that could be impacted by CYP3A4 and CYP 2C19 induction or inhibition and have serious complications for the participant within the treatment period without the ability to discontinue safely with a sufficient washout period before initiating VPV.
✕. Patients on oral contraceptives or estrogen containing hormone replacement therapy.
✕. Ingestion of grapefruit, pomegranate, star fruit and Seville oranges within 14 days prior to dosing. The juices and products containing these fruits should also be avoided.
✕. History of clinically significant infection (respiratory or non-respiratory) requiring antibiotic or systemic steroids \>10 mg/day within 30 days prior to planned RV challenge.