• Anti-InfectiveEnrolling

  Study to evaluate nebulized BX004-A in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (BiomX Phase 1b/2a) , protocol number BiomX BMX-04-001 Part 2

  This study is testing the safety and tolerability of nebulized BX004-A, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (PsA) to find the best dose.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

  • Number of Visits:

    6

  • Length of Participation:

    192 days

• Anti-InfectiveEnrolling

  Study to evaluate nebulized BX004-A in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (BiomX Phase 1b/2a) , protocol number BiomX BMX-04-001 Part 1

  This study is testing the safety and tolerability of nebulized BX004-A, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (PsA) to find the best dose.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    40% or greater

  • Number of Visits:

    7

  • Length of Participation:

    189 days

• ObservationalClosed to Enrollment

  Phase 4 study to monitor the susceptibility of Pseudomonas aeruginosa to aztreonam in people with CF , protocol number Gilead GS-US-205-0128

  This 5-year study took place at multiple care centers across the U.S. It investigated the susceptibility of Pseudomonas aeruginosa isolates to the anti-infective drug aztreonam.

  • Age:

    1 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    Less than 90%

  • Number of Visits:

    5

  • Length of Participation:

    5 years

• Anti-InfectiveCompleted with Results

  Aztreonam Lysinate for Inhalation in Individuals who Utilize Inhaled Tobramycin Frequently (AIR-CF2) , protocol number CP-AI-005

  The purpose of this study was to evaluate the safety and efficacy of an inhaled formulation of aztreonam lysine in CF patients who have respiratory infections caused by the Pseudomonas aeruginosa bacteria.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 75%

  • Number of Visits:

    9

  • Length of Participation:

    18 weeks

• Anti-InfectiveCompleted with Results

  Long-term Safety Study of Aztreonam Lysinate in CF Patients with P. aeruginosa (AIR-CF3) , protocol number CP-AI-006

  The purpose of this study was to evaluate the safety of an inhaled antibiotic, aztreonam, in CF patients who have respiratory infections caused by the Pseudomonas aeruginosa bacteria

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 75%

  • Number of Visits:

    6

  • Length of Participation:

    6 months

• Anti-InfectiveCompleted with Results

  Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with P. aeruginosa (AIR-CF1) , protocol number CP-AI-007

  The purpose of this study was to evaluate the safety and efficacy of an inhaled antibiotic, Aztreonam, in CF patients who have respiratory infections caused by the Pseudomonas aeruginosa bacteria.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 75%

  • Number of Visits:

    5

  • Length of Participation:

    42 days

• Anti-InfectiveCompleted with Results

  Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients with Mild Lung Disease and P. aeruginosa (AIR-CF4) , protocol number GS-US-205-0117

  This study looked at the safety and use of a 28-day treatment with an inhaled antibiotic, aztreonam in CF patients with mild lung disease and positive Pseudomonas aeruginosa culture.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    75% or greater

  • Number of Visits:

    5

  • Length of Participation:

    56 days

• Anti-InfectiveCompleted with Results

  Inhaled Fosfomycin/Tobramycin for People with CF and P. aeruginosa , protocol number Gilead GS-US-207-0103

  The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 75%

  • Number of Visits:

    7

  • Length of Participation:

    14 weeks

• Anti-InfectiveCompleted with Results

  Aztreonam for Inhalation Solution (AZLI) taken in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas aeruginosa lung infections in people with CF , protocol number Gilead GS-US-205-0170

  This study evaluated if continuous alternating treatment with two different types of inhaled antibiotics [Aztreonam for Inhalation Solution (Cayston®) and Tobramycin Inhalation Solution (TIS)] , resulted in better outcomes than an intermittent regimen (28 days on/28 days off) of TIS.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    25 to 75%

  • Number of Visits:

    9

  • Length of Participation:

    7 months

• Anti-InfectiveCompleted with Results

  PALS: Aztreonam Inhalation Solution (AZLI) Safety Study in Children with CF and Chronic Pseudomonas Aeruginosa , protocol number Gilead - GS-US-205-0160

  This open-label study looked at the safety of Aztreonam Inhalation Solution (Cayston®) given three times daily for three 28-day on/28-day off cycles in children with cystic fibrosis and chronic Pseudomonas aeruginosa (PA) infection in the lower airways.

  • Age:

    Less than 13 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

  • Number of Visits:

    8

  • Length of Participation:

    6 months

• Anti-InfectiveCompleted with Results

  Aztreonam (AZLI) in Infants and Children with CF and New Onset Pseudomonas Aeruginosa , protocol number Gilead GS-US-205-0162

  This was an open-label, multi-center trial looking at the safety and effectiveness of Aztreonam Inhalation Solution (Cayston®) given to infants and children with CF, ages 3 months to 17 years, who had a newly detected Pseudomonas aeruginosa lung infection in respiratory cultures.

  • Age:

    3 Months to 17 Years

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    90% or greater

  • Number of Visits:

    5

  • Length of Participation:

    6 months

• Anti-InfectiveCompleted with Results

  AZLI (Inhaled Aztreonam) for People with Cystic Fibrosis and Chronic Burkholderia Infection , protocol number Gilead GS-US-205-0127

  This study looked at the safety and effectiveness of inhaled aztreonam (Cayston®) in people with Cystic Fibrosis and chronic Burkholderia cepacia infection.

  • Age:

    6 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    No FEV1 Limit

  • Number of Visits:

    15

  • Length of Participation:

    48 weeks

Studies in this tool are multi-center studies facilitated by the Cystic Fibrosis Therapeutics Development Network. For a complete list of cystic fibrosis related studies, visit www.clinicaltrials.gov.