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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 12:59 AM
NCT ID:
NCT02730793
Eligibility Criteria:
Inclusion Criteria:
1. Males or females 7 years of age or older and able to perform pulmonary function testing
2. Confirmed diagnosis of CF by the 1997 CF Consensus Conference criteria and followed by the VCU or EVMS CF clinic
3. Presence of PA in 2 lower respiratory tract (sputum) cultures in the 24 months before screening
4. Subjects and/or parent guardian must be able to give written informed consent prior to any study related procedure
5. All sexually active female subjects who are of childbearing potential must agree to use an effective method of contraception (i.e.condoms or abstinence).
6. All sexually active female subjects must have a negative pregnancy test at screening (V0).
7. Clinically stable determined by the study physician with no significant new respiratory symptoms.
8. Presence of PA in nasal culture (swab or secretion) or sinus culture obtained in the 12 months before screening or at screening visit
Exclusion Criteria:
1. Use of oral, IV or inhaled antibiotics within 0 days before study other than low dose azithromycin
2. Severe pulmonary disease with FEV1\<30% predicted of baseline SpO2\<0.90
3. ENT surgery within 6 months of screening
4. Allergy or documented adverse reaction to aztreonam
5. Epistaxis or significant (\>30mL) hemoptysis in the past 6 months
6. Frequent (weekly or more frequently) or severe headaches
7. Subject is unlikely to comply with the procedures scheduled in the protocol
8. Subject participates in another clinical trial within 30 days prior to study entry
9. Subjects who have had a lung transplant will be excluded
10. Prisoners will be excluded
11. Non-English Speaking patients will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
100 Years
Study:
NCT02730793
Study Brief:
Protocol Section:
NCT02730793