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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00620334
Eligibility Criteria:
Inclusion Criteria:
18-64 years of age at enrollment
* Literacy: The subject must be able to read, comprehend, and record information in English.
* Consent: The subject must have the ability to give informed consent.
* Type of subject: The subject must be seen in the outpatient setting.
Exclusion Criteria:
* Respiratory Instability: Hospitalization for respiratory disease within the last 6 months during study period and prior to Visit 0.
* Respiratory Disease: Current diagnosis of cystic fibrosis, pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, or any other lower respiratory abnormalities other than asthma.
* Prior Treatment of Asthma: Treatment for asthma with any medication (except for short acting inhaled bronchodilators) for 12 months or more prior to Visit 0
* Drug Allergy: Any immediate or delayed hypersensitivity reaction to any beta2-agonist or sympathomimetic drug
* Respiratory Tract Infections: Confirmed or suspected infection of the sinus, middle ear, oropharynx, upper respiratory tract, or lower respiratory tract within 28 days prior to testing
* Other Concurrent Conditions/Diseases: Any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. The list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: cardiac arrhythmia, congestive heart failure, coronary artery disease, Addison's disease, diabetes mellitus, dyspnea by any cause other than asthma, uncontrolled hypertension, hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease, immunologic compromise, current malignancy, current or quiescent tuberculosis.
* Concomitant Medications:
1. Beta blockers
2. Systemic corticosteroids
3. Angiotensin Converting Enzyme (ACE) inhibitors (Note: Immunotherapy for the treatment of allergies is allowed, provided that the subject has received a constant dose for 30 days prior to Visit 0, and that the same dose will continue throughout the study.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00620334
Study Brief:
Protocol Section:
NCT00620334