Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT02730793

Run by

Virginia Commonwealth University

People needed

5

Starts

2017-01-01

Expected to finish

2019-09-19

Last updated by the study team

2021-01-28

Who can join

Age: 7 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females 7 years of age or older and able to perform pulmonary function testing
• Confirmed diagnosis of CF by the 1997 CF Consensus Conference criteria and followed by the VCU or EVMS CF clinic
• Presence of PA in 2 lower respiratory tract (sputum) cultures in the 24 months before screening
• Subjects and/or parent guardian must be able to give written informed consent prior to any study related procedure
• All sexually active female subjects who are of childbearing potential must agree to use an effective method of contraception (i.e.condoms or abstinence).
• All sexually active female subjects must have a negative pregnancy test at screening (V0).
• Clinically stable determined by the study physician with no significant new respiratory symptoms.
• Presence of PA in nasal culture (swab or secretion) or sinus culture obtained in the 12 months before screening or at screening visit

You may not qualify if…

• Use of oral, IV or inhaled antibiotics within 0 days before study other than low dose azithromycin
• Severe pulmonary disease with FEV1<30% predicted of baseline SpO2<0.90
• ENT surgery within 6 months of screening
• Allergy or documented adverse reaction to aztreonam
• Epistaxis or significant (>30mL) hemoptysis in the past 6 months
• Frequent (weekly or more frequently) or severe headaches
• Subject is unlikely to comply with the procedures scheduled in the protocol
• Subject participates in another clinical trial within 30 days prior to study entry
• Subjects who have had a lung transplant will be excluded
• Prisoners will be excluded
• Non-English Speaking patients will be excluded

Where it is running

• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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