Clinical trial NCT02354859: A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
Official title: A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Gallium Nitrate
IV Gallium
Pseudomonas aeruginosa
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2015-02-03
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed description: 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

Primary outcomes:
measure: Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 to Day 56
measure: Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 to Day 56
measure: Relative Change in FEV1 (Liters) From Baseline to Day 56
timeFrame: Day 1 to Day 56
measure: Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56
timeFrame: Day 1 to Day 56
measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), From Baseline to Day 56
timeFrame: Day 1 to Day 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: AL Adult Birmingham / The Children's Hospital Atlanta
state: Alabama
city: La Jolla
country: United States
facility: UC San Diego Medical Center
state: California
city: Denver
country: United States
facility: Denver Adult / National Jewish Health
state: Colorado
city: Gainesville
country: United States
facility: Shands Hospital
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital; University of Miami Hospital; University of Miami Hospital and Clinics
state: Florida
city: Atlanta
country: United States
facility: Atlanta Emory Adult / Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Chicago Northwestern Adult / Northwestern Memorial Hospital
state: Illinois
city: Iowa City
country: United States
facility: Iowa City University of Iowa Adult / University of Iowa Hospitals & Clinics
state: Iowa
city: Lexington
country: United States
facility: Lexington, KY Adult / University of Kentucky Chandler Medical Center
state: Kentucky
city: Portland
country: United States
facility: Portland, ME Adult
state: Maine
city: Baltimore
country: United States
facility: Baltimore Hopkins Adult / John Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Boston CHB Adult / Boston Children's Hospital (BCH)
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis CC and Adult / University of Minnesota Medical Center, Fairview
state: Minnesota
city: Omaha
country: United States
facility: Omaha Adult / The Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Lebanon, NH Dartmouth-Hitchcock CC and Adult / Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Cleveland
country: United States
facility: Cleveland CC and Peds, Hospital of Cleveland
state: Ohio
city: Columbus
country: United States
facility: Columbus CC and Peds / Nationwide Children's Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo, OH CC and Peds / The Toledo Hospital; Toledo Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City Adult / Presbyterian Hospital at OU Medical Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: Pittsburgh Adult, Children's Hospital of Pittsburgh UPMC
state: Pennsylvania
city: Charleston
country: United States
facility: SC CC and Adult Charleston / MUSC
state: South Carolina
city: Salt Lake City
country: United States
facility: Salt Lake City Adult, Intermountain Cystic Fibrosis Center
state: Utah
city: Seattle
country: United States
facility: Seattle UW Adult / University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Christopher H Goss, MD
role: PRINCIPAL_INVESTIGATOR
References: