Trial Outcomes & Findings for A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study) (NCT NCT02354859)

Last Updated: 2019-03-21

Results Overview

Difference between treatment groups in the proportion of subjects with 5% or greater relative change in FEV1 (liters) from baseline to Day 28.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

119 participants

Primary outcome timeframe

Baseline to Day 28

Results posted on

2019-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Gallium Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Overall Study STARTED	60	59
Overall Study COMPLETED	60	57
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gallium n=60 Participants Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=59 Participants Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.	Total n=119 Participants Total of all reporting groups
Age, Continuous	31.7 years STANDARD_DEVIATION 10.25 • n=5 Participants	33.8 years STANDARD_DEVIATION 9.62 • n=7 Participants	32.8 years STANDARD_DEVIATION 9.96 • n=5 Participants
Age, Customized Age Distribution · Between 18 and 30 years	30 Participants n=5 Participants	23 Participants n=7 Participants	53 Participants n=5 Participants
Age, Customized Age Distribution · >= 30 years	30 Participants n=5 Participants	36 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	35 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	59 participants n=7 Participants	119 participants n=5 Participants
Cystic Fibrosis (CF) Genotype Delta F508 Homozygous	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Cystic Fibrosis (CF) Genotype Delta F508 Heterozygous	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Cystic Fibrosis (CF) Genotype Other	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Cystic Fibrosis (CF) Genotype Unidentified	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Cystic Fibrosis (CF) Genotype Not Available	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Forced Expiratory Volume in 1 second (FEV1)	2.0 liters STANDARD_DEVIATION 0.95 • n=5 Participants	2.0 liters STANDARD_DEVIATION 0.79 • n=7 Participants	2.0 liters STANDARD_DEVIATION 0.87 • n=5 Participants
FEV1 (% Predicted) Distribution < 50%	28 Participants n=5 Participants	29 Participants n=7 Participants	57 Participants n=5 Participants
FEV1 (% Predicted) Distribution Between 50 and 70%	15 Participants n=5 Participants	12 Participants n=7 Participants	27 Participants n=5 Participants
FEV1 (% Predicted) Distribution > 70%	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

Population: Includes only treated participants with FEV1 measurements at Baseline and Day 28.

Difference between treatment groups in the proportion of subjects with 5% or greater relative change in FEV1 (liters) from baseline to Day 28.

Outcome measures

Outcome measures
Measure	Gallium n=60 Participants Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=56 Participants Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28	22 Participants	17 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 56

Incidence is defined as the number and percentage of participants with at least one event over the 56 day follow-up period.

Outcome measures

Outcome measures
Measure	Gallium n=60 Participants Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=59 Participants Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Incidence of AEs	57 Participants	57 Participants
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Incidence of SAEs	11 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 56

Rate is defined as the number of events per participant follow-up week.

Outcome measures

Outcome measures
Measure	Gallium n=60 Participants Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=59 Participants Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of AEs per participant week	0.84 events per participant-week	1.03 events per participant-week
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of SAEs per participant week	0.02 events per participant-week	0.03 events per participant-week

SECONDARY outcome

Timeframe: Day 1 to Day 56

Difference between treatment groups in the relative change in FEV1 (liters) from Baseline to Day 56

Outcome measures

Outcome measures
Measure	Gallium n=60 Participants Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=59 Participants Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Relative Change in FEV1 (Liters) From Baseline to Day 56	1.89 percentage change Standard Error 16.99	-0.05 percentage change Standard Error 14.14

SECONDARY outcome

Timeframe: Day 1 to Day 56

Population: Includes only participants with a positive P. aeruginosa (Pa) culture at Baseline.

Difference between treatment groups in the absolute change in P. aeruginosa sputum density (log10 (CFU)) from Baseline to Day 56 based on quantitative cultures.

Outcome measures

Outcome measures
Measure	Gallium n=47 Participants Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=45 Participants Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56	-1.06 log10 (CFU) Standard Error 1.97	-0.33 log10 (CFU) Standard Error 1.52

SECONDARY outcome

Timeframe: Day 1 to Day 56

Difference between treatment groups in the absolute change in respiratory symptoms, as measured by the the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from Baseline to Day 56. The Cystic Fibrosis Respiratory Symptoms Daily Diary asks a participant to state the extent of their 8 respiratory symptoms : difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms.

Outcome measures

Outcome measures
Measure	Gallium n=60 Participants Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=59 Participants Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
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 score on a scale Standard Error 13.66	-0.98 score on a scale Standard Error 10.75

Adverse Events

Gallium

Serious events: 11 serious events

Other events: 53 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Christopher H. Goss, Professor of Medicine and Pediatrics

University of Washington

Phone: 206-543-3166

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Gallium n=60 participants at risk Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=59 participants at risk Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Eye disorders Visual impairment	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Abdominal pain	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Distal intestinal obstruction syndrome	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Nausea	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Vomiting	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Chest discomfort	5.0% 3/60 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Chills	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Exercise tolerance decreased	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Fatigue	5.0% 3/60 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Malaise	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Pain	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Pyrexia	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	6.8% 4/59 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Infections and infestations Upper respiratory tract infection	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Investigations Blood creatinine increased	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Investigations Forced expiratory volume decreased	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Investigations Pulmonary function test decreased	3.3% 2/60 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Investigations Weight decreased	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	3.4% 2/59 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	3.4% 2/59 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Musculoskeletal and connective tissue disorders Myalgia	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Nervous system disorders Migraine with aura	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Nervous system disorders Seizure	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Cough	11.7% 7/60 • Number of events 7 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	11.9% 7/59 • Number of events 8 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 5/60 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	13.6% 8/59 • Number of events 11 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Increased viscosity of bronchial secretion	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Sputum increased	5.0% 3/60 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	8.5% 5/59 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Wheezing	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	3.4% 2/59 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).

Measure	Gallium n=60 participants at risk Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device () using an ambulatory infusion pump infused over 24 hours for 5 sequential days. Gallium nitrate: Study subjects will receive an infusion of either placebo or gallium nitrate.	Placebo n=59 participants at risk Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Normal Saline: Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Gastrointestinal disorders Abdominal pain	10.0% 6/60 • Number of events 7 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	8.5% 5/59 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Abdominal pain upper	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Constipation	3.3% 2/60 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Diarrhoea	6.7% 4/60 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	11.9% 7/59 • Number of events 7 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Nausea	15.0% 9/60 • Number of events 13 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	18.6% 11/59 • Number of events 13 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Gastrointestinal disorders Vomiting	6.7% 4/60 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	10.2% 6/59 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Asthenia	10.0% 6/60 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	3.4% 2/59 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Chest discomfort	20.0% 12/60 • Number of events 12 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	22.0% 13/59 • Number of events 15 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Chest pain	8.3% 5/60 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	6.8% 4/59 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Chills	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	6.8% 4/59 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Fatigue	31.7% 19/60 • Number of events 20 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	25.4% 15/59 • Number of events 16 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
General disorders Pyrexia	11.7% 7/60 • Number of events 7 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	23.7% 14/59 • Number of events 16 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Injury, poisoning and procedural complications Contusion	3.3% 2/60 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Investigations Pulmonary function test decreased	5.0% 3/60 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Investigations Weight decreased	6.7% 4/60 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	6.8% 4/59 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Metabolism and nutrition disorders Decreased appetite	13.3% 8/60 • Number of events 9 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	6.8% 4/59 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Musculoskeletal and connective tissue disorders Muscle spasms	6.7% 4/60 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	0.00% 0/59 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Musculoskeletal and connective tissue disorders Myalgia	10.0% 6/60 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	8.5% 5/59 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Musculoskeletal and connective tissue disorders Pain in extremity	6.7% 4/60 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Nervous system disorders Headache	28.3% 17/60 • Number of events 20 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	39.0% 23/59 • Number of events 28 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Nervous system disorders Sinus headache	3.3% 2/60 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Psychiatric disorders Insomnia	0.00% 0/60 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Cough	48.3% 29/60 • Number of events 33 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	45.8% 27/59 • Number of events 34 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.3% 8/60 • Number of events 9 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	23.7% 14/59 • Number of events 17 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Haemoptysis	11.7% 7/60 • Number of events 11 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	16.9% 10/59 • Number of events 11 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 5/60 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	10.2% 6/59 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	13.3% 8/60 • Number of events 10 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	11.9% 7/59 • Number of events 9 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Paranasal sinus hypersecretion	6.7% 4/60 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	6.7% 4/60 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	10.2% 6/59 • Number of events 6 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Rales	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	10.2% 6/59 • Number of events 8 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.7% 4/60 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	10.2% 6/59 • Number of events 12 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Sinus congestion	15.0% 9/60 • Number of events 9 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	3.4% 2/59 • Number of events 2 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Sputum increased	31.7% 19/60 • Number of events 21 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	40.7% 24/59 • Number of events 30 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	5.1% 3/59 • Number of events 3 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Respiratory, thoracic and mediastinal disorders Wheezing	8.3% 5/60 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	13.6% 8/59 • Number of events 11 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Skin and subcutaneous tissue disorders Night sweats	1.7% 1/60 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	8.5% 5/59 • Number of events 5 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).
Skin and subcutaneous tissue disorders Rash	6.7% 4/60 • Number of events 4 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).	1.7% 1/59 • Number of events 1 • For Serious Adverse Events (SAEs): Informed consent to Day 56. For all Other (Not Including Serious) AEs: Start of study drug to final study visit (Day 56).