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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT00128492
Eligibility Criteria:
Inclusion Criteria:
* Compliance with Studies CP-AI-005 (NCT00104520) or CP-AI-007 (NCT00112359) by taking at least 50% of expected study medication.
* Completion of CP-AI-005 or CP-AI-007 or was withdrawn due to need for antipseudomonal antibiotics or for an AE unrelated to study medication tolerance.
* Ability to provide written informed consent/assent prior to initiation of study-related procedures.
* Ability to perform reproducible pulmonary function tests.
Exclusion Criteria:
* Use of any investigational medication or device between the last visit of CP-AI-005 or CP-AI-007 and Visit 1 of this study.
* Concurrent participation in a study of another investigational drug or device.
* Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
* History of sputum or throat swab culture yielding Burkholderia cepacia in the previous 2 years.
* History of daily continuous oxygen supplementation or requirement for more than 2 liters/minute at night.
* Inability to tolerate study medication in CP-AI-005 or CP-AI-007.
* Known local or systemic hypersensitivity to aztreonam.
* Inability to tolerate inhalation of a short acting beta-2 agonist.
* Abnormal renal or hepatic function based on results of most recent test.
* Female of child-bearing potential who was pregnant, lactating, or not (in the opinion of the investigator) practicing an acceptable method of birth control.
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would have interfered with participant treatment, assessment, or compliance with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT00128492
Study Brief:
Protocol Section:
NCT00128492