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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT00531050
Eligibility Criteria:
Inclusion Criteria:
* Patients between 40 and 75 years of age diagnosed with chronic obstructive pulmonary disease (COPD). Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception.
* Body mass index (BMI) must be within the range of 18 to 32.
Exclusion Criteria:
* Participation in any clinical investigation with experimental drug therapy within four weeks prior to dosing or longer as required by local regulation.
* Donation or loss of 400 mL or more of blood within two months prior to dosing.
* Significant illness (other than respiratory) within two weeks prior to dosing.
* A past medical history of, or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome or a prolonged QT-interval at screening.
* Any clinically significant medical abnormalities (excluding COPD) limiting ability to perform standardized exercise protocol on cycle ergometer will exclude the patient. For example, arthritis.
* History of clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis).
* A known hypersensitivity to the study drug or drugs similar to the study drug.
* History of immunocompromise, including a positive HIV, Hepatitis B or C test result.
* History of drug or alcohol abuse within the 12 months prior to dosing
* Any conditions that in the opinion of the investigator may compromise patient safety, interfere with evaluations, or preclude the completion of the trial.
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT00531050
Study Brief:
Protocol Section:
NCT00531050