Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vectura Limited
With
UCB Pharma
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Male or female subject.
Female subjects of non-childbearing potential
Weigh at least 50 kg, and body mass index 18.0-31.0
Peak inspiratory flow (PIF) of at least 60 L/min for at least 2 sec
Forced expiratory volume in 1 sec (FEV1)/forced vital capacity (FVC) ratio of at least 0.7 at the screening visit
Willingness to give written consent to participate after reading the information and consent form
Willingness to give written consent to have data entered into The Over volunteering Prevention System.
Healthy subjects with FEV1 and FVC of at least 80% of the predicted value at the screening visit
Patients with documented clinical history of mild bronchial asthma (mild as defined by the GINA guidelines1) for at least 6 months before the screening visit
Patient FEV1 and FVC of at least 70% of the predicted value at the screening visit
You may not be if
Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment
Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous (excluding mild asthma in Part 2)
Impaired endocrine, thyroid, hepatic, respiratory (excluding mild asthma in Part 2) or renal function, diabetes mellitus, coronary heart disease, cancer, or history of any psychotic mental illness
Respiratory tract infection within 4 weeks before the screening visit
History of surgery or medical intervention, or planned surgery or medical intervention
Presence or history of severe adverse reaction to any drug, or sensitivity to components of the trial medication
Use of a prescription or over-the-counter medicine, with the exception of acetaminophen (paracetamol), during the 7 days before the first dose of trial medication. For Part 2 only, inhaled short-acting ß2 agonists, and ICS (stable dose with at least 2 weeks documented use of ≥80% compliance before screening and Day -1) are permitted
Participation in another clinical trial of a new chemical entity, new device, or a prescription medicine within the 3 months before dosing, or participation within 5 half-lives of receiving an experimental drug (whichever is longer)
Presence or history of drug or alcohol abuse
Evidence of drug abuse on urine testing, or a positive test for alcohol
Current smoker; or ex-smokers who (a) gave up less than 1 year ago, or (b) who have a history of more than 10 pack-years
Blood pressure and heart rate at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min.
Loss of more than 400 mL blood, eg as a blood donor, or donation of blood products, during the 3 months before the trial
Positive test for hepatitis B, hepatitis C, or HIV
Possibility that the subject will not cooperate with the requirements of the protocol, including effective use of the DPI
Life-threatening asthmatic episode in the past
Asthmatic episode or respiratory tract infection requiring steroid treatment in the past 3 months
Use of the following medicines within the specified time before screening:
* Long-acting ß2 agonists; At any time before screening
* Anti IgE therapy; 6 months
* Inhaled corticosteroids (\>500 µg per day of beclometasone dipropionate (BDP) or equivalent); 8 weeks
