Table 5 Proposed Safety Endpoints for Bronchial Provocation Studies in Humans

Adverse Events

Any undesirable experience occurring to a subject during a clinical trial, whether or not considered related to the investigational product

Serious Adverse Events

Any untoward medical occurrence or effect that at any dose:

- results in death;

- is life threatening (at the time of the event);

- requires hospitalisation or prolongation of existing inpatients’ hospitalisation;

- results in persistent or significant disability or incapacity;

- is a congenital anomaly or birth defect;

- is a new event of the trial likely to affect the safety of the subjects, such as an unexpected outcome of an adverse reaction, major safety finding from a newly completed animal study, etc.

Blood pressure

<100/60 mmHg or > 140/90 mmHg

Heart rate

Below 50/min or above 100/min

Temperature

Below 34 °C or above 38 °C

Saturation

Below 90 %

Laboratory testing

More than a 50 % change in blood values concerning liver function, renal function, and bone marrow

FEV₁ or PEF

Decrease of ≥ 20 %

Symptoms

e.g. Chest pain, dyspnea, cough, sore throat, dizziness and syncope