a phase 2 iv gallium study for patients with cystic fibrosis (ignite study)

Conditions: Cystic Fibrosis

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

this is a phase 2, multi-center, randomized, placebo-controlled trial in adults with cf chronically infected with p. aeruginosa. the study will evaluate the safety and clinical efficacy of a five day infusion of iv gallium nitrate (iv gallium). 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.

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

Keywords: cystic fibrosis gallium nitrate iv gallium pseudomonas aeruginosa