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:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT00017693
Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are 12 to 85 years of age (consent of parent or guardian required if under 18 years).
* Have continuous asthma and are being treated with albuterol MDI only.
* Have reduced lung functions.
* Have a positive reaction to 2 substances as demonstrated with a skin test.
* Have been a nonsmoker for at least 2 years and have not smoked more than 1 pack a day for 5 years or less.
* Agree to use contraception throughout the study.
* Agree not to donate blood throughout the study.
* Are able to use correctly an aerosol drug delivery device.
* Have had an asthma attack on at least 3 of the last 7 days.
Exclusion Criteria
Patients will not be eligible for this study if they:
* Had asthma requiring hospitalization within 6 weeks of beginning study treatment.
* Had asthma requiring emergency room treatment within 12 months of beginning study treatment.
* Had a respiratory infection that affected asthma within 2 weeks of beginning study treatment.
* Had a breathing tube inserted for asthma treatment within 15 years of beginning study treatment.
* Were previously enrolled in a study of soluble IL-4 receptor.
* Have drug abuse, alcohol abuse, or a mental illness that may interfere with the study.
* Have serious medical problems (such as heart or lung problems, uncontrolled high blood pressure, are overweight to the extent that ability to breathe is affected, or have cancer other than skin cancer), diabetes, autoimmune diseases, or HIV.
* Are pregnant or breast-feeding.
* Have used certain drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
85 Years
Study:
NCT00017693
Study Brief:
Protocol Section:
NCT00017693