A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Gallium nitrate; Normal Saline
Intervention description: Study subjects will receive an infusion of either placebo or gallium nitrate.; Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Intervention MeSH terms: Gallium nitrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Gallium Nitrate; IV Gallium; Pseudomonas aeruginosa

Summary:

      The purpose of this study is to assess the efficacy of IV gallium to improve pulmonary
      function as measured by a 5% or greater relative improvement in forced expiratory volume in
      one second (FEV1) from baseline to Day 28.

      Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Greater than or equal to 18 years of age at Screening

          -  Documented chronic colonization with P. aeruginosa defined as dentification in two
             sputum or oropharyngeal cultures within the year prior to Day 1

          -  Documentation of a CF diagnosis as evidenced by one or more clinical features
             consistent with the CF phenotype and one or more of the following criteria:

               1. sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test
                  (QPIT)

               2. two well-characterized mutations in the cystic fibrosis transmembrane conductance
                  regulator (CFTR) gene

               3. Abnormal nasal potential difference (NPD; change in NPD in response to a low
                  chloride solution and isoproteronol of less than -5 mV)

          -  FEV1 ≥ 25 % of predicted value at Screening

          -  Able to expectorate sputum

          -  Serum liver function tests ≤ 2.5 x upper limit of normal at Screening

          -  Serum urea nitrogen (BUN) ≤ 1.5 x upper limit of normal at Screening

          -  Serum creatinine ≤ 2.0 mg/dl and ≤ 1.5 x upper limit of normal at Screening

          -  Hemoglobin ≥ 9 g/dl, platelets ≥ 100,000/mm3, and white blood cells (WBC)

             ≥ 4,500/mm3 at Screening

          -  Ionized calcium ≥ lower limit of normal at Screening

          -  Written informed consent obtained from subject or subject's legal representative

          -  Able to communicate with the Investigator and comply with the requirements of the
             protocol

          -  If female and of childbearing potential, must have a negative pregnancy test on Day 1
             prior to receiving study drug

          -  If female and of childbearing potential, is willing to use adequate contraception for
             the duration of the study through Visit 5, as determined by the investigator

          -  If male and able to father a child, is willing to use adequate contraception for the
             duration of the study through Visit 5, as determined by the investigator

          -  Clinically stable with no significant changes in health status within 14 days prior to
             Day 1

        Exclusion criteria:

          -  Use of inhaled antibiotics within seven days prior to Day 1

          -  Unable or unwilling to withhold use of chronic inhaled antibiotics through Day 28

          -  Use of intravenous, inhaled, or oral antibiotics for an acute indication within 14
             days prior to Day 1

          -  Use of bisphosphonates within seven days prior to Day 1

          -  History of osteoporosis (defined as the most recent dexa scan with a T-score ≤ -2.5
             with the dexa scan performed within the five years prior to Screening)

          -  Lactating female

          -  Known sensitivity to gallium