A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02354859
• Date of registration: 30/07/2014
• Prospective Registration: Yes
• Primary sponsor: University of Washington
• Public title: A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
• Scientific title: A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)
• Date of first enrolment: March 2016
• Target sample size: 119
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02354859
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Christopher H Goss, MD
• Affiliation: University of Washington

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Gallium nitrate

Drug: Normal Saline

Primary Outcome(s)

Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28 [Time Frame: Baseline to Day 28]

Secondary Outcome(s)

Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56 [Time Frame: Day 1 to Day 56]

Relative Change in FEV1 (Liters) From Baseline to Day 56 [Time Frame: Day 1 to Day 56]

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 [Time Frame: Day 1 to Day 56]

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Day 1 to Day 56]

Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Day 1 to Day 56]

Secondary ID(s)

2R01FD003704-03A1

STUDY00002609

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation

Results

• Results available: Yes
• Date Posted: 21/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02354859