The role of innate lymphoid cells in asthma and rhinovirus-induced asthma exacerbations

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 46

Inclusion Criteria

Asthmatic patients part 1:
Adult-onset eosinophilic asthma patients with a physician*s diagnosis of asthma that started after the age of 18.
Stable on asthma medication, no exacerbation or changes in asthma medication in the past 4 weeks.
Non-smoking, or ex-smoking (<10py) if the patient has at least 12% improvement in FEV1 after inhalation of 400 µg salbutamol.
Sputum eosinophilia >3%.
Atopic and non-atopic patients will be distinguished based on total serum IgE. Atopy will be defined as a serum IgE levels >= 100.;Asthmatic patients part 2:
Mild-moderate asthmatic patients will be selected using the following inclusion
Age between 18 - 50 years at the screening visit
History of episodic chest tightness and wheezing
Controlled 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 exacerbations within the last 6 weeks prior to the study
Use of ICS at a stable dose-equivalent of <= 500mcg/day fluticasone propionate
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 >3 mm;Control subjects:
Age between 18 - 65 years at the screening visit
Non-smoking or stopped smoking more than 12 months and <= 5 PY
Baseline FEV1 > 80% of predicted
MeBr challenge with PC20 > 9.8 mg/ml
Steroid-naïve or those participants who are currently not on corticosteroids and have not taken any corticosteroids by any dosing-routes within 8 weeks prior to the study
Negative history of pulmonary or any other relevant diseases

Exclusion Criteria

For part 1 and 2:
Women who are pregnant, lactating or have a positive urine pregnancy test at visit 1
Participation in any clinical investigational drug treatment protocol within the preceding 30 days
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;Furthermore the following additional exclusion criteria will be used in part 2 of the study:
RV16 titre > 1:6 in serum, measured at visit 1
History of clinical significant hypotensive episodes or symptoms of fainting, dizziness, or light-headedness
Usage of high dose ICS (>500 µg/day to fluticasone or equivalent). Use of low or medium dose ICS (<=500 µg/day fluticasone or equivalent) with or without permitted controller medications e.g LABA, LTRA is allowed
Experience of an asthma exacerbation in the 12 weeks prior to visit 1 requiring management with systemic steroids
Has had any acute illness, including a common cold, within 4 weeks prior to visit 1
Ongoing use of tobacco products of any kind or previous usage with >= 6 total PY
Close contact with young children (< 2 years)
Has donated blood or has had a blood loss of more than 450 mL within 60 days prior to screening visit 1 or plans to donate blood during the study