A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 Inclusion Criteria Exclusion Criteria Experienced a severe exacerbation within 28 days preceding Visit 1. Yes
No
Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Visit 1. Subjects with a history of allergic rhinitis, seasonal allergy or oesophagitis must be optimally controlled and remain on a stable treatment regimen during the study. Yes
No
Participation in another study within five half lives or three months of the start of this study, whichever is the longer. This does not apply to methodological or observational studies in which no investigational medicinal product (IMP) was given. Yes
No
Lower respiratory tract infection within six weeks of Visit 1.5. Yes
No
Current smokers or ex-smokers with > 10 pack-years (number of pack years = (number of cigarettes per day/20) x number of years smoked, e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years). Yes
No
Blood donation (> 550 mL) in the previous two months. Yes
No
Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or solvent abuse. Yes
No
Subjects with a physician-diagnosis of any other significant lung disease, including a primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis. Yes
No
Concurrent medication from Visit 1 (screening visit) and for the duration of the study with any of the prohibited medications. Yes
No
Significant, uncontrolled disease including serious psychological disorders, chronic renal failure, uncontrolled hypertension Yes
No
hypertension heart disease, psoriasis or stroke Yes
No
Any factor which, in the opinion of the Investigator, would jeopardise the evaluation or safety or be associated with poor adherence to the protocol (i.e. inability to complete study diary, perform PEF measurements). Yes
No
The subject's primary care physician recommends the subject should not take part in the study. Yes
No
Known hypersensitivity to CAT-354 or its components, to the challenge agents used in the study or to related drugs. Yes
No