Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease

• Status: Terminated
• Trial end date: 2019-09-19
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed as a masked, two center, randomized, placebo-controlled pilot study to evaluate the safety and efficacy of nasal and oral inhalation of 75 mg aztreonam in subjects with CF and lung infection due to PA. The study will involve two sites: Virginia Commonwealth University Medical Center (VCU) and Eastern Virginia Medical School (EVMS). Potential subjects will be identified in each site's CF clinic.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Eastern Virginia Medical School
• Treatments: Aztreonam

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