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Cystic Fibrosis

Current Cystic Fibrosis Trials

We invite you to explore our active trials underway at the University of Kansas Medical Center. Please get in touch with our study teams if you have any questions.

Our research is funded by the NIH, Pharma, and the Cystic Fibrosis Foundation and focuses on discovering and developing new and effective CF therapies. We work to support the CF Foundation’s cause in the search for a cure by carrying out a broad range of research studies to tackle the disease from all angles.

Five researchers standing in front of a piece of wall art that looks like a stained glass tree


Interested in Enrolling in a Clinical Study?

PLEASE CLICK HERE AND COMPLETE THE CLINICAL STUDY INTEREST FORM

Information on current studies may be found by choosing a title below:

Pharmaceutical Studies

4D-710-C001 / Gene Therapy

An Open-label, Phase 1/2 Trial of Gene Therapy 4D-710 in Adults with Cystic Fibrosis

CONTACT THE STUDY TEAM
More Information

CMTX101-P1-CT002 / Inhaled Antibiotics

A Phase 1b/2a Study To Evaluate The Safety Of CMTX-101 In Combination With Inhaled Antibiotics In People With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa

  • Enrollment Status: Recruiting
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: CMTX101 / or Placebo
  • Sponsor: Clarametyx
  • PI: Joel Mermis, M.D.
CONTACT THE STUDY TEAM
MORE INFORMATION

CFAAV-001 / Gene Therapy

A single ascending dose, Phase 1/2 trial to evaluate the safety, pharmacokinetics, and pharmacodynamics of SP-101 via nebulizer for the treatment of cystic fibrosis (CF)

  • Enrollment Status: Paused
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: SP-101
  • Sponsor: Spirovant Sciences
  • PI: Joel Mermis, M.D.
CONTACT THE STUDY TEAM
MORE INFORMATION

VX20-121-104 / Combination Therapy

A Phase 3, Open-label Study Evaluating the Long term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis

CONTACT THE STUDY TEAM
MORE INFORMATION

VX21-522-001 / Inhaled mRNA Therapy

A Phase 1/2 Dose-escalation Study Evaluating the Safety, Tolerability, and Efficacy of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy

CONTACT THE STUDY TEAM
MORE INFORMATION
Federally Funded-Foundation Studies

Cystic Fibrosis Foundation Annual Patient Registry


BEGIN / CFTR Modulators and Their Impact on Children with CF

A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN)

     Contact the Study Team             More Information


BEGINNING / CF Pediatrics on CFTR Modulators (Xe MRI)

BEGIN Novel ImagiNG Biomarkers (BEGINNING) Study

     Contact the Study Team   


MAYFLOWERS-OB-20 / Pregnancy in Women with CF

Prospective Study of Pregnancy in Women With Cystic Fibrosis (MAYFLOWERS)

     Contact the Study Team             MORE INFORMATION

CHEC-OB-17 / CFTR Modulated Changes in Sweat Chloride

The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes

     CONTACT THE STUDY TEAM             More Information

NICE-CF / Colorectal Cancer Evaluation

A Multi-Center Study of Non-Invasive Colorectal Cancer Evaluation in Cystic Fibrosis (NICE-CF)

    Contact the Study Team             More Information


REACH-OB-23 / Advance the CF Therapeutics Pipeline for People without Modulators

A Research Study to Advance the CF Therapeutics Pipeline for People without Modulators

     CONTACT THE STUDY TEAM             More Information

STOP360 / Standardizing Treatments for Pulmonarry Exacerbations

Standardizing Treatments for Pulmonary Exacerbations: A platform for evaluating treatment decisions to improve outcomes

  • Enrollment Status: Recruiting
  • Study Type: Interventional
  • Intervention/Treatment: Beta-lactam antibiotic or Aminoglycoside
  • Sponsor: Cystic Fibrosis Foundation
  • PI: Michael Crosser, MD

     Contact the Study Team             More Information

LTx READY CF2 / Lung Transplant Resources

Lung Transplant Resources for Education And Decision-making for Your CF 2 Study: A Multi-Site Randomized Controlled Clinical Trial

  • Enrollment Status: Recruiting
  • Study Type: Interventional
  • Intervention/Treatment: ToT, a CF-specific lung transplant educational website / or an attention control website (unos.org, UNOS)
  • Sponsor: Cystic Fibrosis Foundation / NIH
  • PI: Charles Bengston, MD

     Contact the Study Team             More Information

PACE CF / Mind-Body Pain Management

Pilot of PACE CF, a 3-session mind-body pain management

  • Enrollment Status: Active- Not recruiting
  • Study Type: Interventional
  • Intervention/Treatment: CF-specific Cognitive Behavioral Therapy (CBT)
  • Sponsor: Cystic Fibrosis Foundation
  • PI: Amanda Bruce, PhD

     Contact the Study Team             More Information            

RETRIAL / Monitoring for Adverse Events (Alyftrek)

Restarting Triple Therapy with Robust Monitoring for Adverse Events (RETRIAL)

  • Enrollment Status: Not Yet Recruiting
  • Study Type: Observational
  • Intervention/Treatment: N/A
  • Sponsor: Cystic Fibrosis Foundation
  • PI: Amanda Bruce, PhD

     Contact the Study Team             MORE INFORMATION

HOPeCF / Health Outcomes of Parents with CF

Health Outcomes of Parents with Cystic Fibrosis (HOPe:CF) Aim 2

  • Enrollment Status: Recruiting
  • Study Type: Observational
  • Intervention/Treatment: N/A
  • Sponsor: Cystic Fibrosis Foundation
  • PI: Amanda Bruce, PhD

     CONTACT THE STUDY TEAM             MORE INFORMATION

Bronchitol / Effect of Bronchitol on Mucociliary Clearance

Effect of Bronchitol on Mucociliary Clearance in CFTR-Modulator Treated Patients with Cystic Fibrosis with Moderate to Severe Lung Disease

  • Enrollment Status: Active – Not Recruiting
  • Study Type: Interventional
  • Intervention/Treatment: Bronchitol (FDA-Approved Drug)
  • Sponsor: Chiesi
  • PI: Andreas Schmid, MD

Contact the Study Team             MORE INFORMATION


Investigator-Initiated Studies

Losartan CFTR / Addition of Losartan for Improving CFTR Function

Targeting inflammation to improve rescue of CFTR by modulator therapy

  • Enrollment Status: Recruiting
  • Study Type: Interventional
  • Intervention/Treatment: Losartan (FDA Approved drug) / or Placebo
  • Sponsor: NIH
  • PI: Charles Bengston, MD

     Contact the Study Team             MORE INFORMATION

Nasal Brushing / Evaluating Nasal Inflammation and Ion Channel Modulators

Evaluating nasal inflammation and ion channel modulators in chronic airway diseases including Cystic Fibrosis

     Contact the Study Team          

CF Losartan MCC / Anti-Inflammatory Therapy

Anti-Inflammatory Therapy to Augment CFTR Rescue in CF Patients

     Contact the Study Team             MORE INFORMATION

Metformin CFTR / Addition of Metformin to Improve Ion Channel Function

A randomized, double-blind, crossover clinical trial of metformin in those with CFRD on CFTR modulator therapy to improve ion channel function

EBC Validation / Validating Multiomic Signatures of Exhaled Breath Condensate

Validating Multiomic Signatures of Exhaled Breath Condensate (EBC) In Airways Disease

     CONTACT THE STUDY TEAM            

Completed Non-Pharmaceutical Studies

Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention

Preventing Depression and Anxiety: A Randomized Controlled Trial of a CF-Specific CBT Intervention

Partners Adolescent CBT

Preventing depression and anxiety: Pilot study of a cystic fibrosis-specific cognitive behavioral therapy intervention for adolescents with CF

PAIN

Patient input into the development of a psychological intervention for pain in adults with cystic fibrosis

EATN

Success with Therapies Research Consortium Protocol: Exploring Attitudes Toward Nutrition (EATN)

CONTACT THE STUDY TEAM
More Information

yETI

Success with Therapies Research Consortium Protocol: yETI (your ETI) STUDY

CONTACT THE STUDY TEAM
More Information

Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

Feasibility, Acceptability, and Pilot Randomized Controlled Trial of a Tele-Coaching Intervention to Improve Treatment Adherence in Cystic Fibrosis

STRC-106-16-01

Development of Standardized Measures of Barriers to Treatment Adherence: Field Testing and Psychometric Validation

STRC-109-16-01

Phase 1: Feasibility Assessment and Development of a Tele-Coaching Intervention to Promote Adherence in Patients with Cystic Fibrosis

coopeRATE

Measuring and improving coproduction using coopeRATE: A before-and-after study in adult cystic fibrosis care

  • Enrollment Status: Terminated
  • Study Type: Interventional
  • Intervention/Treatment: coopeRATE Prompt
  • Sponsor: Dartmouth-Hitchcock Medical Center
  • PI: Deepika Polineni, M.D.

coopeRATE Prompt

Feasibility of a goal-based agenda setting intervention for informing conversations in adult Cystic Fibrosis care

  • Enrollment Status: Completed
  • Study Type: Interventional
  • Intervention/Treatment: coopeRATE Prompt
  • Sponsor: Dartmouth-Hitchcock Medical Center
  • PI: Deepika Polineni, M.D.

PICC-CF

Prospective study of peripherally inserted venous catheters in CF patients

COBRE Biorepository

  • Enrollment Status: Active, Not Recruiting
  • Study Type: Observational
  • Intervention/Treatment: N/A
  • Sponsor: Andrew Godwin, Ph.D
  • PI: Deepika Polineni, M.D.

ARNET

Assessing the Transcriptional Response in Nasal Epithelium to the Triple CFTR modulator (ARNET)

SILP MCC

Multisite Qualification Studies Using the Slow Inhalation, Large Particle (SILP) Mucociliary Clearance Measurement Method

  • Enrollment Status: Completed
  • Study Type: Observational
  • Intervention/Treatment: N/A
  • Sponsor: Cystic Fibrosis Foundation
  • PI: Amanda Bruce, Ph.D.

PROMISE-OB-18

A prospective study to evaluate biological and clinical effects of significantly corrected CFTR function (the PROMISE Study)

TGF-β1 CFTR

The effect of TGF-β1 on FEV1 response to CFTR modulator therapy

  • Enrollment Status: Completed
  • Study Type:Observational
  • Intervention/Treatment: N/A
  • Sponsor: The University of Kansas Medical Center
  • PI: Charles Bengtson, M.D.

Sinus Disease in YCwCF

  • Enrollment Status: Completed
  • Study Type:Observational
  • Intervention/Treatment: N/A
  • Sponsor: Cystic Fibrosis Foundation
  • PI: Michael Lewis, M.D.
Completed Pharmaceutical Studies

ACTIV-1

Randomized Master Protocol for Immune Modulators for Treating COVID-19

  • Enrollment Status: Completed
  • Study Type: Interventional
  • Intervention/Treatment: Drug: Infliximab / Abatacept / Remdesivir / Cenicriviroc
  • Sponsor: NIH
  • PI: Matthias Salathe, M.D.

VX18-814-001

A Phase 1 Study of VX-814

CX-280-202

A Phase 1B Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety of CB-280 in Patients with Cystic Fibrosis

STOP-2

Standardized Treatment of Pulmonary Exacerbations (STOP-2)

SAV005-04

A Phase III, randomized, double-blind, placebo-controlled study of AeroVanc for the treatment of persistent methicillin-resistant Staphylococcus aureus lung infection in cystic fibrosis patients

VX18-445-901

VX-445/TEZ/IVA Triple Combination Expanded Access

Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR Mutation

VX18-561-101

A Phase 2, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 and Older With Cystic Fibrosis

VX18-445-903

VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Homozygous for F508del

LAU-14-01

APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults

  • Enrollment Status: Completed
  • Study Type: Interventional (Clinical Trial)
  • Intervention/Treatment: LAU-7b or placebo
  • Sponsor: Laurent Pharmaceuticals Inc.
  • PI: Deepika Polineni, MD

VX17-445-102

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

VX18-445-104

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

AP-PA02-101

A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects with Cystic Fibrosis and Chronic Pulmonary Pseudomonas aeruginosa (Pa) Infection

NAB-BC-3781-1014

A Phase 1, Open-Label, Randomized, Crossover Study to Assess the Safety and Pharmacokinetics Following Single Doses of Oral and Intravenous XENLETA® (Lefamulin) in Adult Patients with Cystic Fibrosis

SPI-3005-501

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, and Efficacy of SPI-1005 in Cystic Fibrosis Patients with Acute Pulmonary Exacerbation Receiving IV Tobramycin at Risk for Ototoxicity

SIMPLIFY-IP-19

A master protocol to test the impact of discontinuing chronic therapies in people with cystic fibrosis on highly effective CFTR modulator therapy (SIMPLIFY)

Insmed 1007-211

A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

VX20-121-102

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)

VX17-445-105

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

VX18-445-110

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)

  • Enrollment Status: Completed
  • Study Type:Interventional (Clinical Trial)
  • Intervention/Treatment: ELX/TEZ/IVA / IVA
Completed Investigator-Initiated Studies

FAMRI Rhinosinusitis

A novel anti-inflammatory therapy for smoke-associated chronic rhinosinusitis

  • Enrollment Status: Completed
  • Study Type: Observational
  • Intervention/Treatment: N/A
  • Sponsor: Flight Attendant Medical Research Institute
  • PI: Matthias Salathe, MD

E-Cigarette

Vaping subjects manifest a signature of airway epithelial cell injury

E-Cigarette Controls

Evaluation of Acute and Subacute Effects of Nicotine Free Electronic Cigarette (NFEC) Vapors – Aim 2.1 of “Adverse Effects of Inhaled Nicotine from Tobacco and E-Cigarettes”

CFF Losartan

Losartan as anti-inflammatory therapy to augment F508del CFTR recovery

  • Enrollment Status: Terminated
  • Study Type: Interventional
  • Intervention/Treatment: Losartan (FDA-approved Drug) / or Placebo
  • Sponsor: Cystic Fibrosis Foundation
  • PI: Matthias Salathe, MD

Losartan AIM 3

Anti-inflammatory Therapy to Augment CFTR Rescue In CF Patients

  • Enrollment Status: Completed
  • Study Type: Interventional
  • Intervention/Treatment: Losartan (FDA-approved Drug)
  • Sponsor: NIH
  • PI: Matthias Salathe, M.D.

Losartan COVID-19

An open label phase 1 trial of losartan for worsening respiratory illness in COVID-19

Exercise MCC

Impact of Exercise on Mucociliary Clearance in Cystic Fibrosis

  • Enrollment Status: Completed
  • Study Type:Interventional
  • Intervention/Treatment: Behavioral: exercise
  • Sponsor: University of Kansas Medical Center
  • PI: Joel Mermis, MD
Internal Medicine

University of Kansas Medical Center
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Kansas City, KS 66160
Phone: 913-588-6045