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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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]
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]
Relative Change in FEV1 (Liters) From Baseline to Day 56 [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
Ethics review
Results
Results available: Yes
Date Posted: 21/03/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02354859
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