Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02730793
• Date of registration: 03/11/2015
• Prospective Registration: Yes
• Primary sponsor: Virginia Commonwealth University
• Public title: Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
• Scientific title: Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease
• Date of first enrolment: January 2017
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02730793
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Bruce K Rubin, MD
• Affiliation: Virginia Commonwealth University

Key inclusion & exclusion 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



Age minimum: 7 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Oral Aztreonam

Drug: Nasal Aztreonam

Drug: Nasal Placebo

Primary Outcome(s)

Number of protocol-defined pulmonary exacerbations treated with IV anti-pseudomonal antibiotics on day 140 [Time Frame: 140 days]

Secondary Outcome(s)

Change in Sinus and Nasal QoL questionnaire (SNOT-20) on day 140 and day 168 [Time Frame: Day 140 and Day 168]

Number of protocol-defined pulmonary exacerbations treated with oral anti-pseudomonal antibiotics [Time Frame: 1 year]

Change in acoustic Rhinometry for nasal obstruction (volume) (will be measured at VCU site ). [Time Frame: 1 year]

Number of Safety and adverse events including nasal stuffiness, epistaxis, and headache. [Time Frame: 1 year]

Time to first protocol-defined pulmonary exacerbation treated with IV anti-pseudomonal antibiotics [Time Frame: Up to 6 months]

Change in Cystic Fibrosis QoL score (CFQ-R) on day 140 [Time Frame: Day 140]

Change in paired sputum cultures and nasal swabs for bacteria and antibiotic resistance [Time Frame: 1 year]

Change in Pulmonary function (FVC and FEV1 percent predicted) on day 140 [Time Frame: Day 140]

Secondary ID(s)

HM20005657

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eastern Virginia Medical School