Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
Study Details
Study Description
Brief Summary
The goal of the study is to examine multiple markers of anthropometrics, body composition, sarcopenia and frailty and compare them to dual energy X-ray absorptiometry (DXA) output, which is considered the current clinical gold-standard tool to measure body composition. The result of this study will provide detailed data regarding the nutrition and body composition within this Cystic Fibrosis population and also provide a baseline evaluation for use of these biomarkers in the future studies including evaluation of nutritional intervention. Further, the study will also include psychosocial and other patient-reported outcomes and medical contributors to understand their contributions to the nutritional failure in the adult advanced lung disease population. Finally, the study will evaluate both established and emerging nutritional and body composition parameters and link them to clinical outcomes in adults with CF across the spectrum of pulmonary function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Forced expiratory volume in 1 second (FEV1) <60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). If no stable spirometry data are available in the 12 months prior to enrollment, from the prior 24 months will be used. |
Diagnostic Test: BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI
Diagnostic Test: Tricepts skinfold (TSF) and Mid-arm muscle circumference (MAMC) and lean mass index from DXA
Triceps skinfold (TSF) will be assessed with calipers. Mid-arm circumference will be measured with a tape measure.Mid-arm muscle circumference (MAMC) will be calculated as: mid-arm circumference - (3.1416 x tricep skinfold).
Diagnostic Test: Hand-grip strength and lean mass index from DXA
A small, handheld dynamometer (Jamar Instruments) will be used to measure grip strength, a measure of function, on each hand. Participants will be asked to squeeze the instrument as hard as they can for 3 seconds, which will measure the pounds of force applied.
Diagnostic Test: 6 minute walk and lean mass index from DXA
This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes. The total distance walked in that time will be measured. Vital signs will be monitored during the test.
Diagnostic Test: 1 minute site to stand and lean mass index from DXA
This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.
Diagnostic Test: Short physical performance battery (SPPB) frailty score and lean mass index from DXA
This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) two 3-4 meter gait speed tests; and 3) chair-stand tests (single chair stand, 5 chair stands).
Diagnostic Test: BIA Substudy
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA). For this procedure, participants will lie still on a table for <5 minutes with electrodes placed on hands and feet. Estimated measurements will include fat-free mass and fat mass. Additional BIA variables to be collected will include phase angle, resistance, and reactance. BIA data will be transferred directly from the BIA machine to an excel file on a secure server and then uploaded to the secure study website.
Diagnostic Test: Accelerometry to assess physical activity
Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer for 3 days. Participants will be able to keep their accelerometers.
Other: Gastrointestinal (GI) and nutrition questionnaires
Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).
Other: Psychosocial questionnaire: PHQ-8
This is an 8-item scale that measures depressive symptoms over the past two weeks. A score of 5-9 indicates mild depressive symptoms, 10-14 moderate, 15-19 moderately severe, and 20-24 severe.
Other: Psychosocial questionnaire: GAD-7
This is a 7-items scale that measures anxiety symptoms over the past few days, from not at all to nearly every day. A score of 5-9 indicates mild anxiety, 10-14 moderate, 15-19 moderately severe, and 20-24 severe anxiety.
Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated with possible item responses ranging from 1 (not at all true) to 7 (very true). The TSRQ includes 3 subscales: autonomous motivations (6 item; e.g., "It is consistent with my life goals" It is an important choice I really want to make"), controlled motivations (6 items; e.g., "I would feel guilty or ashamed of myself if I did not" "Others would be upset with me if I did not"), and amotivation (3 items; e.g., "It is easier to do what I am told than to think about it"). The TSRQ reliable and valid across several health behaviors, including diet, and has been used with individuals aged 14-80 years. 74,75 TSRQ scores are associated with adherence.
Other: Psychosocial questionnaire: CF Fatalism Scale
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items rated on a scale of 0=Strongly Disagree to 4=Strongly Agree. It consists of two types of items Fate (6 items; e.g., " My life will be shortened by CF no matter what I do, so there is no point in doing my treatments" "If my CF is fated to get worse, it will happen; there is not much I can do to change my fate") and Control (7 items: e.g., "God is responsible for my health, not my treatments" "I cannot help that I have CF, but I can control my disease by doing my treatments").
Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
The Body Esteem Scale for Adolescents and Adults (BESAA) is an 23 item scale (rated on scale of 1=never to 5= (always). 81 The BESAA measures self-evaluations of one's body or appearance and has 3 subscales: BE-Appearance (10 items about general feelings about appearance), BE-Weight (8 items about weight satisfaction), and BE-Attribution (5 items about evaluations attributed to others about one's body and appearance). The BESAA subscales have good internal consistency and test-retest reliability individuals' age 12-25 years. Lower BE-Appearance and BE-Weight scores are associated with obesity) while lower total BESAA scores are associated with higher risk of anorexia nervosa
Other: STRONG Participant Experience Survey
A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants.
Other: Oral glucose tolerance testing (OGTT)
For subjects without previously diagnosed CFRD, an OGTT will be performed and samples analyzed at the central lab. Fasting glucose will be drawn followed by administration of 75g oral dextrose, with repeat plasma glucose levels then drawn at 60 minutes and 120 minutes. A repeat OGTT will be performed at the 12-month follow-up visit unless the participant was diagnosed with CFRD during the study period.
Device: Continuous glucose monitoring (CGM)
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data. Sensors will be placed at the baseline, 6-month and 12-month follow up study visits
Diagnostic Test: Chest CT scans (When available within the past 6 months) to assess
Standard of Care chest CT DICOM images will be drawn from the electronic medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch, as previously described (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4028743/). Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.
Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA)
DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA (Hologic Inc., Bedford, MA, USA) and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. Participants will be asked to lie still on a scanning table with their arms at their sides for approximately 15-20 minutes. This will be used as the gold standard from which to validate BIA and MAMC.
Diagnostic Test: Sub-study of assessment of appendage muscles using ultrasound
A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient. Ultrasound measurements will be obtained using an ultrasound machine that can be transported for use in clinic and a high-resolution small parts transducer. The total time to obtain ultrasound measurements will be around 10 minutes per session. Once the ultrasound is complete, the images will be transferred from the ultrasound machine to a HIPAA compliant flash drive. The images will then be uploaded into the secure study website. ImageJ software will be used by a central reader to analyze and determine measurements. Details related to procedures for the ultrasound, such as positioning and landmarks, will be provided in the study operations manual.
Diagnostic Test: Hunger Vital Sign
Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity.
|
| Cohort 2 FEV1 ≥60% predicted during the 12 months prior to enrollment (>50% of measurements, eliminating periods of exacerbation). |
Diagnostic Test: BMI and lean mass index from DXA
Estimate and compare correlation between lean mass index from DXA and BMI
Diagnostic Test: Tricepts skinfold (TSF) and Mid-arm muscle circumference (MAMC) and lean mass index from DXA
Triceps skinfold (TSF) will be assessed with calipers. Mid-arm circumference will be measured with a tape measure.Mid-arm muscle circumference (MAMC) will be calculated as: mid-arm circumference - (3.1416 x tricep skinfold).
Diagnostic Test: Hand-grip strength and lean mass index from DXA
A small, handheld dynamometer (Jamar Instruments) will be used to measure grip strength, a measure of function, on each hand. Participants will be asked to squeeze the instrument as hard as they can for 3 seconds, which will measure the pounds of force applied.
Diagnostic Test: 6 minute walk and lean mass index from DXA
This will be another functional assessment of fitness. Participants will be asked to walk at their normal pace for 6 minutes. The total distance walked in that time will be measured. Vital signs will be monitored during the test.
Diagnostic Test: 1 minute site to stand and lean mass index from DXA
This will be used as a functional assessment of fitness and lower extremity strength. Participants will start seated on a chair and be asked to complete as many sit-to-stand repetitions without using their arms for one minute.
Diagnostic Test: Short physical performance battery (SPPB) frailty score and lean mass index from DXA
This is an assessment of frailty. The test is completed in approximately 8 minutes. The test consists of 3 assessments: 1) balance tests where the participant stands and tries to balance with their feet in various positions for 10 seconds each without assistance (side-by-side, heel-to-side, and heel-to-toe); 2) two 3-4 meter gait speed tests; and 3) chair-stand tests (single chair stand, 5 chair stands).
Diagnostic Test: BIA Substudy
A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA). For this procedure, participants will lie still on a table for <5 minutes with electrodes placed on hands and feet. Estimated measurements will include fat-free mass and fat mass. Additional BIA variables to be collected will include phase angle, resistance, and reactance. BIA data will be transferred directly from the BIA machine to an excel file on a secure server and then uploaded to the secure study website.
Diagnostic Test: Accelerometry to assess physical activity
Participants will be provided with a wrist-worn accelerometer/heart rate monitor at the baseline study visit and asked to wear it continuously for at least 3 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer for 3 days. Participants will be able to keep their accelerometers.
Other: Gastrointestinal (GI) and nutrition questionnaires
Subjects will complete surveys regarding gastrointestinal (GI) symptoms, including the Patient Assessment of Constipation (PAC-SYM) Score, Patient Assessment of Gastrointestinal Symptoms (PACGI-SYM) Score, the Bristol Stool Chart, and the scored Patient-Generated Subjective Global Assessment (PG-SGA).
Other: Psychosocial questionnaire: PHQ-8
This is an 8-item scale that measures depressive symptoms over the past two weeks. A score of 5-9 indicates mild depressive symptoms, 10-14 moderate, 15-19 moderately severe, and 20-24 severe.
Other: Psychosocial questionnaire: GAD-7
This is a 7-items scale that measures anxiety symptoms over the past few days, from not at all to nearly every day. A score of 5-9 indicates mild anxiety, 10-14 moderate, 15-19 moderately severe, and 20-24 severe anxiety.
Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ)
This is a 15-item scale that assesses the degree to which participants' motivation is autonomous or self-regulated with possible item responses ranging from 1 (not at all true) to 7 (very true). The TSRQ includes 3 subscales: autonomous motivations (6 item; e.g., "It is consistent with my life goals" It is an important choice I really want to make"), controlled motivations (6 items; e.g., "I would feel guilty or ashamed of myself if I did not" "Others would be upset with me if I did not"), and amotivation (3 items; e.g., "It is easier to do what I am told than to think about it"). The TSRQ reliable and valid across several health behaviors, including diet, and has been used with individuals aged 14-80 years. 74,75 TSRQ scores are associated with adherence.
Other: Psychosocial questionnaire: CF Fatalism Scale
The CF Fatalism Scale measures the belief in a lack of personal power or control over one's future and has 13 items rated on a scale of 0=Strongly Disagree to 4=Strongly Agree. It consists of two types of items Fate (6 items; e.g., " My life will be shortened by CF no matter what I do, so there is no point in doing my treatments" "If my CF is fated to get worse, it will happen; there is not much I can do to change my fate") and Control (7 items: e.g., "God is responsible for my health, not my treatments" "I cannot help that I have CF, but I can control my disease by doing my treatments").
Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA)
The Body Esteem Scale for Adolescents and Adults (BESAA) is an 23 item scale (rated on scale of 1=never to 5= (always). 81 The BESAA measures self-evaluations of one's body or appearance and has 3 subscales: BE-Appearance (10 items about general feelings about appearance), BE-Weight (8 items about weight satisfaction), and BE-Attribution (5 items about evaluations attributed to others about one's body and appearance). The BESAA subscales have good internal consistency and test-retest reliability individuals' age 12-25 years. Lower BE-Appearance and BE-Weight scores are associated with obesity) while lower total BESAA scores are associated with higher risk of anorexia nervosa
Other: STRONG Participant Experience Survey
A short questionnaire designed to explore participants' perspectives of the acceptability and feasibility of nutritional assessments used in STRONG-CF will be given to all study participants.
Other: Oral glucose tolerance testing (OGTT)
For subjects without previously diagnosed CFRD, an OGTT will be performed and samples analyzed at the central lab. Fasting glucose will be drawn followed by administration of 75g oral dextrose, with repeat plasma glucose levels then drawn at 60 minutes and 120 minutes. A repeat OGTT will be performed at the 12-month follow-up visit unless the participant was diagnosed with CFRD during the study period.
Device: Continuous glucose monitoring (CGM)
Subjects will wear a Dexcom G6Pro sensor in blinded mode for three 10-day periods to collect comprehensive glucose data. Sensors will be placed at the baseline, 6-month and 12-month follow up study visits
Diagnostic Test: Chest CT scans (When available within the past 6 months) to assess
Standard of Care chest CT DICOM images will be drawn from the electronic medical record, as available, from enrolled participants. FEV1 measurements prior to chest CT scans will be recorded to account for possible illness occurring at the time of scanning. Quantitative assessment of the pectoralis muscle area will be performed on the first single axial image above the aortic arch, as previously described (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4028743/). Any additional standard of care chest CT's that are performed while the participant is enrolled in the study will also be collected and have a quantitative assessment of the pectoralis muscle performed.
Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA)
DXA measurements for whole body, total hip and lumbar spine will be acquired using the Hologic DXA (Hologic Inc., Bedford, MA, USA) and standard positioning as noted in the DXA Manual of Operations. DXA will be used to estimate total and regional body composition, which will include body fat and lean body mass. Participants will be asked to lie still on a scanning table with their arms at their sides for approximately 15-20 minutes. This will be used as the gold standard from which to validate BIA and MAMC.
Diagnostic Test: Sub-study of assessment of appendage muscles using ultrasound
A minimum of 50 individuals will be enrolled. At each study visit, participants will undergo ultrasound muscle measurements (cross-sectional area and muscle thickness) of the biceps and quadriceps on each (left and right) side of the body (4 total areas). These measurements will be obtained in triplicate for each patient. Ultrasound measurements will be obtained using an ultrasound machine that can be transported for use in clinic and a high-resolution small parts transducer. The total time to obtain ultrasound measurements will be around 10 minutes per session. Once the ultrasound is complete, the images will be transferred from the ultrasound machine to a HIPAA compliant flash drive. The images will then be uploaded into the secure study website. ImageJ software will be used by a central reader to analyze and determine measurements. Details related to procedures for the ultrasound, such as positioning and landmarks, will be provided in the study operations manual.
Diagnostic Test: Hunger Vital Sign
Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity.
|
Outcome Measures
Primary Outcome Measures
- Correlation between DXA lean mass index and BMI [Baseline and 1 year]
Estimate and compare correlation between lean mass index from DXA (kg/m2) and BMI (kg/m2)
- Correlation between DXA lean mass index and mid-arm muscle circumference [Baseline and 1 year]
Estimate and compare correlation between lean mass index from DXA (kg/m2) and mid-arm muscle circumference (cm)
- Correlation between DXA lean mass index and hand-grip strength [Baseline and 1 year]
Estimate and compare correlation between lean mass index from DXA (kg/m2) and hand-grip strength (kg)
- Correlation between DXA lean mass index and the 6-minute walk distance traveled [Baseline and 1 year]
Estimate and compare correlation between lean mass index from DXA (kg/m2) and 6-minute walk (distance traveled in six minutes)
- Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions [Baseline and 1 year]
Estimate and compare correlation between lean mass index from DXA (kg/m2) and 1-minute sit-to-stand (number of sit-to-stand repetitions in one minute)
- Correlation between DXA lean mass index and Short Physical Performance Battery frailty score [Baseline and 1 year]
Estimate and compare correlation between lean mass index from DXA (kg/m2) and Short Physical Performance Battery frailty score (total points)
Secondary Outcome Measures
- Characterize lean mass index from DXA cross-sectionally and longitudinally [Baseline and 1 year]
Characterize lean mass index from DXA cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
- Characterize BMI cross-sectionally and longitudinally [Baseline and 1 year]
Characterize lean mass index from BMI cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
- Characterize mid-arm measurement circumference cross-sectionally and longitudinally [Baseline and 1 year]
Characterize lean mass index from mid-arm circumference measurements cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
- Characterize hand-grip strength cross-sectionally and longitudinally [Baseline and 1 year]
Characterize hand-grip strength cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
- Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally [Baseline and 1 year]
Characterize the 1 minute sit-to-stand repetitions cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
- Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally [Baseline and 1 year]
Characterize the 6-minute walk test distance traveled cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
- Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally [Baseline and 1 year]
Characterize the Short Physical Performance Battery frailty score cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
- Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60% [Baseline and 1 year]
Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
- Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60% [Baseline and 1 year]
Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
- Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60% [Baseline and 1 year]
Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
- Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60% [Baseline and 1 year]
Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
- Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60% [Baseline and 1 year]
Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
- Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60% [Baseline and 1 year]
Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
- Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60% [Baseline and 1 year]
Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
- Evaluate mean glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate mean glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
- Evaluate % time above 140 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate % time above 140 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
- Evaluate % time above 180 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate % time above 180 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
- Evaluate peak glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate peak glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
- Evaluate % time below 70 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate % time below 70 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
- Evaluate % time below 54 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate % time below 54 mg/dL from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
- Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
- Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60% [Baseline and 1 year]
Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60%
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.
-
Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.
-
Both cohorts match by age, gender, race and CFTR genotype severity.
Exclusion Criteria:
-
No prior whole organ transplantation
-
No initiation of an investigation drug within 28 days prior to and including Visit 1
-
No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
-
No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract sympoms within 14 days prior to and including Visit 1.
-
For the BIA substudy - Individuals with an implanted pacemaker will be excluded.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arizona | Tucson | Arizona | United States | 85724 |
| 2 | University of Arkansas for Medical Sciences (UAMS) | Little Rock | Arkansas | United States | 72205 |
| 3 | Yale University School of Medicine | New Haven | Connecticut | United States | 06520 |
| 4 | Emory | Atlanta | Georgia | United States | 30324 |
| 5 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 6 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 7 | University of Kentucky | Lexington | Kentucky | United States | 40508 |
| 8 | John Hopkins University | Baltimore | Maryland | United States | 21287 |
| 9 | Massachusetts General Hospital (MGH) | Boston | Massachusetts | United States | 02114 |
| 10 | Boston Children's Hospital and Brigham and Women's CF Center | Boston | Massachusetts | United States | 02120 |
| 11 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
| 12 | St. Louis University | Saint Louis | Missouri | United States | 63104 |
| 13 | Washington University School of Medicine (St. Louis) | Saint Louis | Missouri | United States | 63110 |
| 14 | New York Medical College (NYMC) | Hawthorne | New York | United States | 10532 |
| 15 | Northwell LIJ Adult Cystic Fibrosis Center | New Hyde Park | New York | United States | 11040 |
| 16 | University of Cincinnati | Cincinnati | Ohio | United States | 45220 |
| 17 | University Hospitals | Cleveland | Ohio | United States | 44106 |
| 18 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 19 | Penn State College of Medicine | Hershey | Pennsylvania | United States | 17033 |
| 20 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15224 |
| 21 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 22 | Baylor University | Houston | Texas | United States | 77030 |
| 23 | University of Virginia Cystic Fibrosis Center | Charlottesville | Virginia | United States | 22908 |
| 24 | West Virginia University | Morgantown | West Virginia | United States | 26506-9214 |
Sponsors and Collaborators
- Jaeb Center for Health Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STRONG-CF