A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
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|ClinicalTrials.gov Identifier: NCT02354859|
Recruitment Status : Completed
First Posted : February 3, 2015
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Gallium nitrate Drug: Normal Saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||February 1, 2018|
Active Comparator: 5 day of infusion of gallium nitrate
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.
Drug: Gallium nitrate
Study subjects will receive an infusion of either placebo or gallium nitrate.
Other Name: Ga, GaN3O9
Placebo Comparator: 5 day of infusion of normal saline
Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga
Drug: Normal Saline
Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
Other Name: Sodium Chloride, NS
- Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28 [ Time Frame: Baseline to 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.
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.
- Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 to Day 56 ]Rate is defined as the number of events per participant follow-up week.
- Relative Change in FEV1 (Liters) From Baseline to Day 56 [ Time Frame: Day 1 to Day 56 ]Difference between treatment groups in the relative change in FEV1 (liters) from Baseline to Day 56
- Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56 [ Time Frame: Day 1 to Day 56 ]Difference between treatment groups in the absolute change in P. aeruginosa sputum density (log10 (CFU)) from Baseline to Day 56 based on quantitative cultures.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354859
|Principal Investigator:||Christopher H Goss, MD||University of Washington|