Phase
Condition
Common Cold
Emphysema
Common Cold (Pediatric)
Treatment
Placebo
Vapendavir
Clinical Study ID
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female age ≥40 years and ≤75 years at the time of signing the informedconsent form.
If sexually active and/or of child-bearing potential (both females and males), mustagree to use a highly effective forms of contraception ≥ 28 days prior to the firstdose (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 ofchildbearing potential (WOCBP), i.e. fertile, following menarche and until becomingpost-menopausal unless permanently sterile. Permanent sterilisation methods includehysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausalstate is defined as no menses for 12 months without an alternative medical cause. Ahigh follicle stimulating hormone (FSH) level in the postmenopausal range may beused to confirm a postmenopausal state in women not using hormonal contraception orhormonal replacement therapy. However, in the absence of 12 months of amenorrhea, asingle FSH measurement is insufficient. Highly effective contraception is defined asmethods that can achieve a failure rate of less than 1% per year when usedconsistently and correctly. Males (including those with a vasectomy): agree to use a condom and if a femalepartner of childbearing potential, use of at least one other contraceptive method;males must also agree not to donate sperm within 90 days after the last dose). WOCBP participants must use at least one highly effective contraceptive method. Birth control methods which may be considered as highly effective:
Combined (estrogen and progestogen containing) hormonal contraceptionassociated with inhibition of ovulation
oral
intravaginal
transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation
oral
injectable
implantable
intrauterine device (IUD)
intrauterine hormone-releasing system ( IUS)
bilateral tubal occlusion
vasectomised partner
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?"
If on maintenance therapy, be medically stable for at least 2 months prior toenrolment.
Clinically stable with no exacerbations within 2 months prior to enrolment.
Ability to understand and give informed consent.
Exclusion
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 astuberculosis (TB), idiopathic pulmonary fibrosis (IPF), or other majorrespiratory 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 physicalimpairment that is not considered by the investigator medically stable/controlled.
Prescription or over-the-counter medications or herbal products that could beimpacted by CYP3A4 and CYP 2C19 induction or inhibition and have seriouscomplications for the participant within the treatment period without the ability todiscontinue 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 daysprior to dosing. The juices and products containing these fruits should also beavoided.
History of clinically significant infection (respiratory or non-respiratory)requiring antibiotic or systemic steroids >10 mg/day within 30 days prior to plannedRV challenge.
Pregnant, planning to become pregnant, testing positive for pregnancy at thescreening visit test, or nursing females during and within 30 days of treatment.
Any cold symptom within the last 6 weeks such as sore throat, sneezing, rhinorrhoea,malaise, nasal obstruction or cough.
Presence (at screening) of serum rhinovirus 16 neutralising antibody titers atgreater than or equal to one in four (≥1/4) dilution.
Active allergic rhinitis, active nasal disease such as nasal polyposis, chronicrhinosinusitis etc.
Active alcohol and/or drug misuse, at the discretion of the Investigator.
Use of any over the counter cold prophylaxis products including nasal sprays,C-vitamins, zinc or Echinacea within 1 month prior to the enrolment.
Participation in other clinical trial with medical investigational product within 30days or 5 drug half-lives (whichever is longer) prior to enrolment.
Hypersensitivity/allergy to any of the active or placebo ingredients/ components.
Individuals with close contact to at risk patient group, including:
Infants (less than 6 months);
The extremely elderly or infirm;
Pregnant and/or breastfeeding women;
Patients with immunosuppression (e.g., human immunodeficiency virus (HIV),transplant recipients on anti-rejection medications, those undergoing chemo- orimmuno-therapy).
Other factors that in the opinion of the investigator are considered a risk.
Study Design
Study Description
Connect with a study center
St. Mary's Hospital - Imperial College Respiratory Research Unit (ICRRU)
London, W2 1NY
United KingdomSite Not Available
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