Is NCT04580368 recruiting in Cincinnati, OH?

Yes, NCT04580368 is currently recruiting participants at its Cincinnati, OH location. This cystic fibrosis clinical trial is actively enrolling qualified participants.

How do I join the cystic fibrosis clinical trial in Cincinnati?

To join this clinical trial in Cincinnati, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Cincinnati clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Cystic Fibrosis Clinical Trial in Cincinnati, OH

About This Cystic Fibrosis Study in Cincinnati

The purpose of this study is to validate and utilize a personalized medicine approach to identify potential treatments with current FDA approved CFTR modifiers for non-approved CF gene mutations. The study will perform ex vivo testing of CFTR function and current marketed CFTR modulating drugs on expanded nasal cells at Cincinnati Children's Human Nasal Epithelium (HNE) Core Laboratory. The results will be confirmed and translated into bedside care through an N of 1 trial to determine effectiveness of treatment.

Sponsor: Children's Hospital Medical Center, Cincinnati

Who Can Participate

Inclusion Criteria

Signed informed consent (and assent when applicable)

Willing and able to adhere to the study visit schedule and protocol requirements

Male or Female ≥6 years old and within the FDA-approved range for the proposed modulator drug

Ivacaftor: ≥4 months old

Lumacaftor/Ivacaftor: 2 years old

Tezacaftor/Ivacaftor: 12 years old

Elexacaftor/Tezacaftor/Ivacaftor: ≥12 years old

At least one rare CFTR variant (incidence of \<5% of the CF population)

Documentation of a CF diagnosis as evidenced by one or more clinical features of CF plus at least one of the following:

Sweat Chloride ≥60mmol/L by quantitative pilocarpine iontophoresis

Two mutations in the CFTR gene

Abnormal nasal potential difference (NPD) testing supportive of a CF diagnosis

FEV1 \> 50% predicted for age

Stable chronic CF therapies with no changes in \>28 days (except for chronic cycled inhaled antibiotics such as tobramycin)

Prescribed CFTR modulator by a licensed physician

No contraindication to treatment with the selected drug at the time of treatment initiation

Exclusion Criteria

Presence of any condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient and/or quality of the data

For women of child bearing potential:

Positive pregnancy test or known pregnancy at Visit 1

Unwilling to practice a medically acceptable form of contraception (acceptable forms include abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study

BMI \< 10th percentile for age (if \<18 years old) or \< 20kg/m2 (if ≥18 years old)

FEV1 ≤ 50% predicted for age

Growth of CF pathogens from sputum cultures that are associated with unstable disease (e.g., nontuberculous mycobacteria, Burkholderia spp) within six months of enrollment

Concomitant use of CYP3A inducers or inhibitors (e.g., voriconazole, fluconazole, rifampin) or prednisone (\>20mg daily)

Concomitant conditions:

Poorly controlled diabetes mellitus (HbA1c \>8.5 or glucosuria as noted below)

Advanced CF liver disease (cirrhosis with portal hypertension, ascites, or abnormal liver laboratory testing as noted below)

End stage renal disease

History of organ transplantation

Additional medical conditions that in the opinion of the Investigator place the patient at risk of participation or may impact the patient's ability to complete the trial (e.g., uncontrolled depression, anxiety disorder, poor adherence to CF therapies, active ABPA)

Any of the following abnormal laboratory values at the Screening Visit:

WBC \>15,000 K/mcL or ANC \<1,500 K/mcL

Hemoglobin \<10 gm/dL

Platelets \<50,000 K/mcL

Chemistries

\>2+ Glucosuria

Clinically significant abnormalities as assessed by the Investigator

Glomerular filtration rate ≤50 mL/min/1.73 m2 (calculated by the Counahan-Barratt equation)

Hepatic Function Testing / Coagulation Testing

≥3 × upper limit of normal (ULN) aspartate aminotransferase (AST)

≥3 × ULN alanine aminotransferase (ALT)

≥3 × ULN gamma-glutamyl transpeptidase

Total or direct bilirubin \>2 × ULN

INR \> 1.5 x ULN

Positive pregnancy test

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Cincinnati?

Yes, this clinical trial (NCT04580368) has an active research site in Cincinnati, OH that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Cystic Fibrosis Treatment Options in Cincinnati, OH

If you're searching for cystic fibrosis treatment options in Cincinnati, OH, this clinical trial (NCT04580368) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Cincinnati research site is actively enrolling participants for this clinical trial. You'll receive care from experienced cystic fibrosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all cystic fibrosis clinical trials near you to find additional studies recruiting in your area.

Cystic Fibrosis Clinical Trial in Cincinnati, OH

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