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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT01333904
Eligibility Criteria:
Main Inclusion Criteria Parts I \& II
* Healthy males or non pregnant, non lactating healthy females;
* Age 18-65 years of age;
* Must be willing and able to communicate in English and participate in the whole study;
* Must provide written informed consent.
Main Exclusion Criteria Parts I \& II
* Current smokers and those who have smoked within the last 12 months;
* Females of child bearing age not willing to use an acceptable form of contraception;
* Presence or history of allergy requiring treatment;
* Serious adverse reaction or hypersensitivity to any drug;
Main Inclusion Criteria: Parts III and IV
* Males or non pregnant, non lactating females;
* Age 45-70 years;
* Current (Part III only) or ex-smokers who at least a 15 pack-year smoking history. For Part IV, subjects must be non-smokers for at least 3 months;
* Medically stable, with no evidence of uncontrolled co-existing conditions at screening;
* Must not be taking any inhaled or oral corticosteroids;
* FEV1/FVC ratio \<70% and FEV1 60 - 80% (or \>/= 60% for Part IV only) of predicted following administration of a bronchodilator;
* Patients must have a medical history of COPD confirmed by their General Practitioner (GP) or treating hospital physician or must have a chest x-ray (CXR) which is normal or consistent with mild COPD and excludes other clinically significant respiratory abnormalities;
* Must be willing and able to communicate in English and participate in the whole study;
* Must provide written informed consent.
Main Exclusion Criteria: Parts III and IV
* Must agree to use an adequate method of contraception;
* Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 60 days;
* Patients taking medication that may affect the respiratory tract within 14 days of the first study day other than their usual COPD medication;
* No active exacerbations requiring antibiotics or steroids within 60 days of dosing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01333904
Study Brief:
Protocol Section:
NCT01333904