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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT00605306
Eligibility Criteria:
Inclusion Criteria:
* Male and female adult patients aged 18-65 years (inclusive)
* Patients with mild-moderate asthma
* Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient.
* Body mass index (BMI) must be within the range of 18-32 kg/m\^2.
* Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.
Exclusion Criteria:
* Patients who suffer from chronic obstructive pulmonary disease (COPD)
* Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start
* QTcF interval \> 450 msec in men and \>470 msec in women
* Pregnant women or nursing mothers
* Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable).
* History of immunocompromise, including a positive human immunodeficiency virus (HIV)
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* History of drug or alcohol abuse within 12 months of dosing
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00605306
Study Brief:
Protocol Section:
NCT00605306