Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

• ClinicalTrials.gov Identifier: NCT05639556
• Recruitment Status: Recruiting
• First Posted: December 6, 2022
• Last Update Posted: February 13, 2024
• Sponsor: Jaeb Center for Health Research
• Information provided by (Responsible Party): Jaeb Center for Health Research

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

Cystic Fibrosis

Diagnostic Test: BMI and lean mass index from DXA; Diagnostic Test: Anthropometric Measurements; Diagnostic Test: Hand-grip strength; Diagnostic Test: Six-minute walk Test; Diagnostic Test: Sit-to-Stand Test; Diagnostic Test: Short physical performance battery (SPPB); Diagnostic Test: BIA Sub-study; Diagnostic Test: Accelerometry to assess physical activity; Other: Gastrointestinal (GI) and nutrition questionnaires: Other: Psychosocial questionnaire: PHQ-8; Other: Psychosocial questionnaire: GAD-7; Other: Psychosocial questionnaire: The Treatment Self-Regulation Questionnaire (TSRQ); Other: Psychosocial questionnaire: CF Fatalism Scale; Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA); Other: 12-month Questionnaire; Other: Oral glucose tolerance testing (OGTT); Device: Continuous glucose monitoring (CGM); Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records); Diagnostic Test: Hologic Dual X-Ray Absorptiometry (DXA); Diagnostic Test: Ultrasound Sub-study of assessment of appendage muscles using ultrasound; Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire; Other: Respiratory symptom questionnaire: CRISS; Diagnostic Test: Spirometry; Other: Psychosocial questionnaire: Additional Health Questionnaire

Study Design

• Study Type: Observational
• Estimated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF
• Actual Study Start Date: April 20, 2023
• Estimated Primary Completion Date: December 2028
• Estimated Study Completion Date: December 2028

Groups and Cohorts

Group/Cohort	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: Anthropometric Measurements; Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.; Diagnostic Test: Hand-grip strength; A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.; Diagnostic Test: Six-minute walk Test; 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.; Diagnostic Test: Sit-to-Stand Test; 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); 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 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).; Diagnostic Test: BIA Sub-study; A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).; 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 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. 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.; Other: Psychosocial questionnaire: GAD-7; This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.; 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.; 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.; Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA); The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.; Other: 12-month Questionnaire; 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 at the end of the study.; Other: Oral glucose tolerance testing (OGTT); For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.; 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.; Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records); Standard of Care chest CT images will be drawn from the 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. 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 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. This will be used as the gold standard from which to validate BIA and MAMC.; Diagnostic Test: Ultrasound 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.; Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire; Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.; Other: Respiratory symptom questionnaire: CRISS; Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.; Diagnostic Test: Spirometry; Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.; Other: Psychosocial questionnaire: Additional Health Questionnaire; Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.
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: Anthropometric Measurements; Skinfold will be assessed with calipers. Circumference will be measured with a tape measure.; Diagnostic Test: Hand-grip strength; A small, handheld dynamometer will be used to measure grip strength, a measure of function, on each hand.; Diagnostic Test: Six-minute walk Test; 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.; Diagnostic Test: Sit-to-Stand Test; 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); 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 4-meter gait speed tests; and 3) Chair-stand tests (single chair stand, 5 chair stands).; Diagnostic Test: BIA Sub-study; A minimum of 50 individuals will be enrolled. Body composition will be assessed at each study visit using study bioelectrical impendence analysis (BIA).; 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 3-10 days (two weekdays, one weekend day). Approximately every 3 months, the participant will be asked to again wear the accelerometer. 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.; Other: Psychosocial questionnaire: GAD-7; This is a 7-items scale that measures anxiety symptoms over the past two weeks, from not at all to nearly every day.; 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.; 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.; Other: Psychosocial questionnaire: Body Esteem Scale for Adolescents and Adults (BESAA); The Body Esteem Scale for Adolescents and Adults (BESAA) is 23-item measurement of self-evaluations of one's body or appearance.; Other: 12-month Questionnaire; 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 at the end of the study.; Other: Oral glucose tolerance testing (OGTT); For subjects without previously diagnosed CFRD, an OGTT will be performed at baseline and 12-months with samples analyzed at the central lab.; 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.; Diagnostic Test: Chest CT scans (When available within the past 6 months in medical records); Standard of Care chest CT images will be drawn from the 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. 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 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. This will be used as the gold standard from which to validate BIA and MAMC.; Diagnostic Test: Ultrasound 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.; Diagnostic Test: Psychosocial questionnaire: Hunger Vital Sign questionnaire; Screening tool for identifying households at risk of food insecurity and poor health outcomes linked to food insecurity with 3-items over the last 12 months.; Other: Respiratory symptom questionnaire: CRISS; Chronic Respiratory Infection Symptom Score (CRISS) is an 8-item respiratory symptom questionnaire covering the last 24-hours.; Diagnostic Test: Spirometry; Spirometry will be performed in accordance with the current American Thoracic Society recommendations for the performance and interpretation of tests.; Other: Psychosocial questionnaire: Additional Health Questionnaire; Single question over the last 3 months/90 days about cannabis use for GI problems and appetite. The clinical sites will not see the responses to this question. It will be completed by the participant online either during the study visit or at home.

Outcome Measures

Primary Outcome Measures :

1. Correlation between DXA lean mass index and BMI [ Time Frame: Baseline and 1 year ]
   Estimate and compare correlation between lean mass index from DXA (kg/m2) and BMI (kg/m2)
2. Correlation between DXA lean mass index and mid-arm muscle circumference [ Time Frame: Baseline and 1 year ]
   Estimate and compare correlation between lean mass index from DXA (kg/m2) and mid-arm muscle circumference (cm)
3. Correlation between DXA lean mass index and hand-grip strength [ Time Frame: Baseline and 1 year ]
   Estimate and compare correlation between lean mass index from DXA (kg/m2) and hand-grip strength (kg)
4. Correlation between DXA lean mass index and the 6-minute walk distance traveled [ Time Frame: 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)
5. Correlation between DXA lean mass index and the 1-minute sit-to-stand number of repetitions [ Time Frame: 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)
6. Correlation between DXA lean mass index and Short Physical Performance Battery frailty score [ Time Frame: 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 :

1. Characterize lean mass index from DXA cross-sectionally and longitudinally [ Time Frame: 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
2. Characterize BMI cross-sectionally and longitudinally [ Time Frame: 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
3. Characterize mid-arm measurement circumference cross-sectionally and longitudinally [ Time Frame: 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
4. Characterize hand-grip strength cross-sectionally and longitudinally [ Time Frame: Baseline and 1 year ]
   Characterize hand-grip strength cross-sectionally (at enrollment) and longitudinally (post-enrollment changes) based on descriptive statistics and evaluate variance
5. Characterize 1 minute sit-to-stand repetitions cross-sectionally and longitudinally [ Time Frame: 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
6. Characterize mid-arm 6-minute walk test distance traveled cross-sectionally and longitudinally [ Time Frame: 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
7. Characterize the Short Physical Performance Battery frailty score cross-sectionally and longitudinally [ Time Frame: 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
8. Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
   Compare lean mass index from DXA between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
9. Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
   Compare BMI between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
10. Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare lean mass index from mid-arm muscle circumference between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
11. Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare hand-grip strength between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
12. Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare the 1-minute sit-to-stand repetitions between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
13. Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare the 6-minute walk test distance between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
14. Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Compare the Short Physical Performance Battery frailty score between participants with FEV1 <60% to matched participants with FEV1 ≥60%.
15. Evaluate mean glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate mean glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
16. Evaluate % time above 140 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: 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%
17. Evaluate % time above 180 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: 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%
18. Evaluate peak glucose in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate peak glucose from continuous glucose measurement data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
19. Evaluate % time below 70 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: 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%
20. Evaluate % time below 54 mg/dL in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: 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%
21. Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60% [ Time Frame: Baseline and 1 year ]
    Evaluate the standard deviation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%
22. Evaluate the coefficient of variation in CGM glucose data in participants with FEV1 <60% and matched participants with FEV1 ≥60%participants with FEV1 ≥60% [ Time Frame: 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%

Biospecimen Retention:   Samples Without DNA

Serum, plasma, urine and stool samples will be collected.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults 18 and older with a confirmed diagnostic of cystic fibrosis, identified genotypes (when available), no prior solid organ transplant, and not pregnant or planning on becoming pregnant during the 1st year of the study. Participants receiving a lung transplantation while enrolled in the study will not need to be withdrawn.

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 solid 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 symptoms within 14 days prior to and including Visit 1.
• For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
• No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit.
• Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.

Contacts and Locations

Contacts

Contact: Judy Sibayan; (813) 975-8690; jsibayan@jaeb.org

Locations

United States, Arizona

University of Arizona; Recruiting

Tucson, Arizona, United States, 85724

Contact: Cori Daines cdaines@arizona.edu

Contact: Elizabeth Ryan 520-626-3125 elizabethryan@email.arizona.edu

United States, Arkansas

University of Arkansas for Medical Sciences (UAMS); Recruiting

Little Rock, Arkansas, United States, 72205

Contact: Rajani Jagana 501-686-5525 RJagana@uams.edu

Contact: Kathleen Hicks hicksKathleenT@uams.edu

United States, Connecticut

Yale University School of Medicine; Not yet recruiting

New Haven, Connecticut, United States, 06520

Contact: Marie Egan 203-785-5852 marie.egan@yale.edu

United States, Georgia

Emory; Recruiting

Atlanta, Georgia, United States, 30324

Contact: William Hunt 404-778-7929 randy.hunt@emory.edu

Contact: Joy Dangerfield 4047787929 jdanger@emory.edu

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: Adam Stein 312-695-4077 adam.stein@northwestern.edu

Contact: Rachel Nelson rachel.nelson@northwestern.edu

United States, Iowa

University of Iowa; Not yet recruiting

Iowa City, Iowa, United States, 52242

Contact: Tahuanty Pena 319-384-7645 tahuanty-pena@uiowa.edu

Contact: Mary Teresi mary-teresi@uiowa.edu

United States, Kentucky

University of Kentucky; Recruiting

Lexington, Kentucky, United States, 40508

Contact: Mark Wurth 859-257-5087 mark.wurth@uky.edu

Contact: Christina Payne 859-257-5087 christina.payne@uky.edu

United States, Louisiana

Tulane University; Not yet recruiting

New Orleans, Louisiana, United States, 70112

Contact: Ross Klingsberg 504-400-4316 rklingsb@tulane.edu

Contact: Bailey Doctor 504-988-7215 bdoctor@tulane.edu

United States, Maryland

John Hopkins University; Recruiting

Baltimore, Maryland, United States, 21287

Contact: Noah Lechtzin 410-955-1167 nlechtz@jhmi.edu

Contact: Azar Nouraky azar.nouraky@jhmi.edu

United States, Massachusetts

Massachusetts General Hospital (MGH); Recruiting

Boston, Massachusetts, United States, 02114

Contact: Melissa Putman msputman@partners.org

Contact: Amy Sabean asabean@mgh.harvard.edu

Boston Children's Hospital and Brigham and Women's CF Center; Recruiting

Boston, Massachusetts, United States, 02120

Contact: Gregory Sawicki 617-355-1834 Gregory.Sawicki@childrens.harvard.edu

Contact: Tucker Reynard Tucker.Reynard@childrens.harvard.edu

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55455

Contact: Joanne Billings 612-625-7995 billi001@umn.edu

Contact: Alyssa Perry 612-625-7995 ahperry@umn.edu

United States, Missouri

Washington University School of Medicine (St. Louis); Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Jeffrey Atkinson 314-747-2940 atkinsonj@wustl.edu

Contact: Irma Bauer irmabauer@wustl.edu

United States, New York

New York Medical College (NYMC); Recruiting

Hawthorne, New York, United States, 10532

Contact: Allen Dozor 914-404-0152 Allen_dozor@nymc.edu

Contact: Armando Ramirez Aramirez7@nymc.edu

Northwell LIJ Adult Cystic Fibrosis Center; Not yet recruiting

New Hyde Park, New York, United States, 11040

Contact: Janice Wang 516-465-5412 jwang@northwell.edu

Contact: Cara Fidnarick cfidnari@northwell.edu

United States, Ohio

University of Cincinnati; Recruiting

Cincinnati, Ohio, United States, 45220

Contact: Veronica Indihar 513-558-7036 indihama@ucmail.uc.edu

Contact: Nicole Hummel 513-558-7036 hummelne@ucmail.uc.edu

University Hospitals; Recruiting

Cleveland, Ohio, United States, 44106

Contact: Kimberly McBennett 216-286-0709 kimberly.McBennett@uhhospitals.org

Contact: Emily Witte 216-286-0709 Emily.Witte@Uhhospitals.org

United States, Oklahoma

University of Oklahoma Sciences Center; Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contact: Nighat F Mehdi 405-271-6216 nighat-mehdi@ouhsc.edu

Contact: Tiffany McCrabb tiffany-mccrabb@ouhsc.edu

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Aaron Trimble 503-418-8108 trimblea@ohsu.edu

Contact: Brendan Klein 503-418-8108 kleinb@ohsu.edu

United States, Pennsylvania

University of Pittsburgh Medical Center; Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contact: Joseph Pilewski 412-692-5873 pilewskijm@upmc.edu

Contact: Paul Rebovich 412-692-5873 paul.rebovich@chp.edu

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29425

Contact: Christina Mingora 843-792-3710 mingora@musc.edu

Contact: Audra Wiser wisera@musc.edu

United States, Texas

Baylor University; Not yet recruiting

Houston, Texas, United States, 77030

Contact: Sunjay Devarajan 832-822-3300 sunjay.devarajan@bcm.edu

Contact: Jessica Farrell jessica.farrell@bcm.edu

United States, Virginia

University of Virginia Cystic Fibrosis Center; Recruiting

Charlottesville, Virginia, United States, 22908

Contact: Linsay Somerville 434-297-7773 LL7Y@hscmail.mcc.virginia.edu

Contact: Anne Stewart acs8qr@uvahealth.org

Sponsors and Collaborators

Jaeb Center for Health Research

Investigators

• Principal Investigator: Adam Stein; Northwestern
• Principal Investigator: Jessica Alvarez; Emory University
• Principal Investigator: Melissa Putman; Massachusetts General Hospital

More Information

• Responsible Party: Jaeb Center for Health Research
• ClinicalTrials.gov Identifier: NCT05639556
• Other Study ID Numbers: STRONG-CF
• First Posted: December 6, 2022
• Last Update Posted: February 13, 2024
• Last Verified: February 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cystic Fibrosis; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases