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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01FD003704-03A1 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gallium nitrate | Drug | Study subjects will receive an infusion of either placebo or gallium nitrate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 56 |
| Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
Not provided
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher H Goss, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AL Adult Birmingham / The Children's Hospital Atlanta | Birmingham | Alabama | 35233 | United States | ||
| UC San Diego Medical Center |
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2016 | Jan 4, 2019 |
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| Normal Saline | Drug | Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate. |
|
|
Rate is defined as the number of events per participant follow-up week. |
| 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 | 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. | 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. | Day 1 to Day 56 |
| La Jolla |
| California |
| 92037 |
| United States |
| Denver Adult / National Jewish Health | Denver | Colorado | 80206 | United States |
| Shands Hospital | Gainesville | Florida | 32610 | United States |
| Jackson Memorial Hospital; University of Miami Hospital; University of Miami Hospital and Clinics | Miami | Florida | 33136 | United States |
| Atlanta Emory Adult / Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Chicago Northwestern Adult / Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Iowa City University of Iowa Adult / University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| Lexington, KY Adult / University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40506-9983 | United States |
| Portland, ME Adult | Portland | Maine | 04102 | United States |
| Baltimore Hopkins Adult / John Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| Boston CHB Adult / Boston Children's Hospital (BCH) | Boston | Massachusetts | 02115 | United States |
| Minneapolis CC and Adult / University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
| Omaha Adult / The Nebraska Medical Center | Omaha | Nebraska | 68198-5300 | United States |
| Lebanon, NH Dartmouth-Hitchcock CC and Adult / Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Cleveland CC and Peds, Hospital of Cleveland | Cleveland | Ohio | 44106 | United States |
| Columbus CC and Peds / Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Toledo, OH CC and Peds / The Toledo Hospital; Toledo Children's Hospital | Toledo | Ohio | 43606 | United States |
| Oklahoma City Adult / Presbyterian Hospital at OU Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| Pittsburgh Adult, Children's Hospital of Pittsburgh UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| SC CC and Adult Charleston / MUSC | Charleston | South Carolina | 29425 | United States |
| Salt Lake City Adult, Intermountain Cystic Fibrosis Center | Salt Lake City | Utah | 84132 | United States |
| Seattle UW Adult / University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| FG001 | 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. |
|
| COMPLETED | Completed last study visit (Day 56) |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Cystic Fibrosis (CF) Genotype | Other refers to participants with either two known, non-F508 del CF mutations, or one known, non-F508 del CF mutation and one unidentified allele which has not been classified as a CF mutation. Unidentified refers to participants with 2 alleles that have not been classified as CF mutations. | Count of Participants | Participants |
| |||||||||||||||
| Forced Expiratory Volume in 1 second (FEV1) | Mean | Standard Deviation | liters |
| |||||||||||||||
| FEV1 (% Predicted) Distribution | FEV1 (% predicted) is calculated using the Hankinson reference equations. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Includes only treated participants with FEV1 measurements at Baseline and Day 28. | Posted | Count of Participants | Participants | Baseline to Day 28 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Day 1 to Day 56 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Rate is defined as the number of events per participant follow-up week. | Posted | Number | events per participant-week | Day 1 to Day 56 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Mean | Standard Error | percentage change | Day 1 to Day 56 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Includes only participants with a positive P. aeruginosa (Pa) culture at Baseline. | Posted | Mean | Standard Error | log10 (CFU) | Day 1 to Day 56 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | 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. | Posted | Mean | Standard Error | score on a scale | Day 1 to Day 56 |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 60 | 11 | 60 | 53 | 60 |
| EG001 | 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. | 0 | 59 | 9 | 59 | 55 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Distal intestinal obstruction syndrome | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Exercise tolerance decreased | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Forced expiratory volume decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Increased viscosity of bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher H. Goss, Professor of Medicine and Pediatrics | University of Washington | 206-543-3166 | goss@uw.edu |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Aug 28, 2014 | Jan 4, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C027235 | gallium nitrate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided
| >= 30 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Delta F508 Heterozygous |
|
| Other |
|
| Unidentified |
|
| Not Available |
|
| Between 50 and 70% |
|
| > 70% |
|
|
|
|
|
|
|
| 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. |
|
|
|