Cystic FibrosisPhase 2NCT02354859
A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study)
A Phase 2 study testing Gallium nitrate and Normal Saline in people with Cystic Fibrosis, run by University of Washington at 23 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Gallium nitrate and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 23 sitesUnited States
- Study dates
- Mar 2016to 1 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 20Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Atlanta Emory Adult / Emory University Hospital
Atlanta, Georgia, 30322
Baltimore Hopkins Adult / John Hopkins Hospital
Baltimore, Maryland, 21205
AL Adult Birmingham / The Children's Hospital Atlanta
Birmingham, Alabama, 35233
Boston CHB Adult / Boston Children's Hospital (BCH)
Boston, Massachusetts, 02115
SC CC and Adult Charleston / MUSC
Charleston, South Carolina, 29425
Chicago Northwestern Adult / Northwestern Memorial Hospital
Chicago, Illinois, 60611
Cleveland CC and Peds, Hospital of Cleveland
Cleveland, Ohio, 44106
Columbus CC and Peds / Nationwide Children's Hospital
Columbus, Ohio, 43205
Denver Adult / National Jewish Health
Denver, Colorado, 80206
Shands Hospital
Gainesville, Florida, 32610
Iowa City University of Iowa Adult / University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
UC San Diego Medical Center
La Jolla, California, 92037
Lebanon, NH Dartmouth-Hitchcock CC and Adult / Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Lexington, KY Adult / University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40506-9983
Jackson Memorial Hospital; University of Miami Hospital; University of Miami Hospital and Clinics
Miami, Florida, 33136
Minneapolis CC and Adult / University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
Oklahoma City Adult / Presbyterian Hospital at OU Medical Center
Oklahoma City, Oklahoma, 73104
Omaha Adult / The Nebraska Medical Center
Omaha, Nebraska, 68198-5300
Pittsburgh Adult, Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224
Portland, ME Adult
Portland, Maine, 04102
Salt Lake City Adult, Intermountain Cystic Fibrosis Center
Salt Lake City, Utah, 84132
Seattle UW Adult / University of Washington Medical Center
Seattle, Washington, 98195
Toledo, OH CC and Peds / The Toledo Hospital; Toledo Children's Hospital
Toledo, Ohio, 43606
About this study
Official title: A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)
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
Read the detailed description
This is a phase 2, multi-center, randomized, placebo-controlled trial in adults with CF chronically infected with P. aeruginosa. The study will evaluate the safety and clinical efficacy of a five day infusion of IV gallium nitrate (IV gallium). 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Gallium nitrate, Normal Saline
- Keywords
- Cystic Fibrosis, Gallium Nitrate, IV Gallium, Pseudomonas aeruginosa
- Medical subject headings
- Cystic Fibrosis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium nitrateDrug
Also called Ga, GaN3O9
Study subjects will receive an infusion of either placebo or gallium nitrate.
Normal SalineDrug
Also called Sodium Chloride, NS
Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
| Study group | Role | What they receive |
|---|---|---|
| 5 day of infusion of gallium nitrate | Active comparator | 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. Receives: Drug: Gallium nitrate |
| 5 day of infusion of normal saline | Placebo comparator | Placebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From 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.
Measured: Baseline to Day 28
Secondary outcomes (5)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence is defined as the number and percentage of participants with at least one event over the 56 day follow-up period.
Measured: Day 1 to Day 56
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Rate is defined as the number of events per participant follow-up week.
Measured: Day 1 to Day 56
Relative Change in FEV1 (Liters) From Baseline to Day 56
Difference between treatment groups in the relative change in FEV1 (liters) from Baseline to Day 56
Measured: Day 1 to Day 56
Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline 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.
Measured: 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
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.
Measured: Day 1 to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMar 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Chris Goss, University of Washington
- Investigators
- Christopher H Goss, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354859
- Sponsor's protocol ID
- STUDY00002609
- Other IDs
- 2R01FD003704-03A1
- Status last verified
- Mar 2019
- First submitted
- 30 Jul 2014
- Last updated
- 21 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Once the study is complete and the primary paper is published, de-identified data will be available from the Cystic Fibrosis Therapeutics Development Network Coordinating Center upon approval of a formal data request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study)
- ClinicalTrials.gov ID
- NCT02354859
- Acronym / sponsor ID
- STUDY00002609
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Gallium Nitrate, IV Gallium, Pseudomonas aeruginosa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- Mar 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a phase 2, multi-center, randomized, placebo-controlled trial in adults with CF chronically infected with P. aeruginosa. The study will evaluate the safety and clinical efficacy of a five day infusion of IV gallium nitrate (IV gallium). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5 day of infusion of gallium nitrate | Active comparator | Drug: Gallium nitrateGallium 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. |
| 5 day of infusion of normal saline | Placebo comparator | Drug: Normal SalinePlacebo with be dispensed as 1,000 milliliters of 0.9% sodium chloride to match the reconstitution volume of the IV Ga |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- FEV1 ≥ 25 % of predicted value at Screening
- Able to expectorate sputum
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium nitrateAlso: Ga, GaN3O9Study subjects will receive an infusion of either placebo or gallium nitrate. | Drug | 5 day of infusion of gallium nitrate |
| Normal SalineAlso: Sodium Chloride, NSStudy subjects will receive an infusion of either placebo (normal saline) or gallium nitrate. | Drug | 5 day of infusion of normal saline |
Primary outcome
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.
5 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Once the study is complete and the primary paper is published, de-identified data will be available from the Cystic Fibrosis Therapeutics Development Network Coordinating Center upon approval of a formal data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher H Goss, MD principal investigator
University of Washington
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gallium nitrate and Normal Saline in people with Cystic Fibrosis, run by University of Washington at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28 (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.