Phase 2
Completed N=119
A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
Source: ClinicalTrials.gov NCT02354859 ↗Enrolled (actual)
119
Serious AEs
16.8%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28 — 22; 17 Participants — p=0.811
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28 |
22; 17 | 0.811 |
| SECONDARY Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
57; 57; 11; 9 | 0.807 |
| SECONDARY Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
0.84; 1.03; 0.02; 0.03 | 0.002 sig |
| SECONDARY Relative Change in FEV1 (Liters) From Baseline to Day 56 |
1.89; -0.05 | 0.479 |
| SECONDARY Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56 |
-1.06; -0.33 | 0.054 |
| SECONDARY 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 |
3.03; -0.98 | 0.053 |
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:
- sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT)
- two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
- 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
Data sourced from ClinicalTrials.gov (NCT02354859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.