Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01520051
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 - 50 years
* History of episodic chest tightness and wheezing
* Intermittent or mild persistent asthma according to the criteria by the Global Initiative for Asthma
* Non-smoking or stopped smoking more than 12 months ago and ≤ 5 pack years (PY)
* Clinically stable, no history of exacerbations within the last 6 weeks prior to the study
* Steroid-naïve or those patients who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 2 weeks prior to the study. Occasional usage of inhaled short-acting beta2-agonists as rescue medication is allowed, prior and during the study
* Baseline FEV1 \> 80% of predicted
* Airway hyperresponsiveness, indicated by a positive acetyl-ß-methylcholine bromide (MeBr) challenge with PC20 \< 9.8 mg/ml
* Positive skin prick test (SPT) to one or more of the 12 common aeroallergen extracts, defined as a wheal with an average diameter of \> 3mm
* No other clinically significant abnormality on medical history and clinical examination
Exclusion Criteria:
* Presence of antibodies directed against RV16 in serum (titer \> 4), measured at visit 1
* History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness
* Women who are pregnant, lactating or who have a positive urine pregnancy test at visit 1
* Chronic use of any other medication for treatment of lung disease other than short-acting beta2-agonists
* Participation in any clinical investigational drug treatment protocol within the preceding 3 months
* Ongoing use of tobacco products of any kind or previous usage with ≥ 6 total PY
* Concomitant disease or condition which could interfere with the conduct of the study, or for which the treatment might interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient
* People with young children (\< 2 years)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01520051
Study Brief:
Protocol Section:
NCT01520051