Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Nose Diseases; Fibrosis
Intervention: Oral Aztreonam; Nasal Aztreonam; Nasal Placebo
Intervention description: Standard Therapy Comparator (Oral Cayston 75mg three times a day); Study Therapy (nasal Aztreonam 75mg twice per day); Placebo (nasal saline twice per day)
Intervention MeSH terms: Aztreonam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 7 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; P. aeruginosa (PA)

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.
    

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