Status:
TERMINATED
Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Eastern Virginia Medical School
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
7-100 years
Phase:
PHASE2
Brief 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 l...
Detailed Description
This study is designed to explore the efficacy and safety of nasal aztreonam administered using the Pari Sinus Nebulizer combined with oral Cayston aerosol therapy compared to placebo on clinical and ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT02730793
Start Date
January 1 2017
End Date
September 19 2019
Last Update
January 28 2021
Active Locations (1)
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1
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States, 23298