We invite all of our cystic fibrosis patients to participate in clinical trials, so that we can continue to find new and better ways to care for them. Below is a brief description of some of our current clinical trials. If you or a child you know is interested in participating one of our clinical trials, please contact one of the research coordinators.

Baby Observational and Nutrition Study

This research study is being done to learn more about possible factors that may affect growth in babies with cystic fibrosis (CF). CF often affects the pancreas, a part of the body that makes chemicals, called enzymes. Enzymes are necessary for digestion of food. Babies with CF often have problems with digesting fats and other nutrients from food. This can affect their growth.

It is possible that other factors also affect growth in babies with CF. Some examples are diet, bacteria or germs in the intestines, medications and illness. The researchers also would like to develop better ways to measure growth in babies with CF.

Infants who are between 2 weeks and 3½ months old and diagnosed with CF are eligible to enroll in the study. Study information and specimens, including urine and stool, will be collected at clinic visits from the time of consent to 12 months of age. Collection of additional specimens is optional.

After the study is completed, any unused specimens may be stored permanently. The information, or data, collected in the study may also be stored indefinitely. This is called specimen and data banking and is optional. The banked specimens and data may be used by researchers in the future.

Compensation for the visits required by the study will be provided.

Principal investigator

Lucas Hoffman, MD, PhD

Contact

Sharon McNamara, MN, and Alan Genatossio, BSN, 206-987-3921
Request more information  

Development of an Observer Reported Outcome of Respiratory Signs for Young Children with Cystic Fibrosis

This is an observational study to evaluate two new symptom diaries for children with cystic fibrosis. Enrollment in this study is for six months. Using a secure Internet database, families will be asked to update antibiotic use and complete symptom diaries during well and sick periods.

Children with a diagnosis of CF who are less than 12 years of age may be eligible to take part. Families must have access to the Internet via a smartphone or computer.

Children may enroll in this study during a CF clinic visit.

Principal Investigator

Margaret Rosenfeld, MD, MPH

Contact

Alan Genatossio, BSN and Sharon McNamara, MN, 206-987-3921 or Janine Jijina, BS, 206-987-1265
Request more information  

Early MRSA Therapy in CF - Culture-Based vs. Observant Therapy (Treat or Observe)

Methicillin-resistant Staphylococcus aureus (MRSA) is a bacteria found in the lungs of some people with CF; these bacteria are also found in people without CF. MRSA is more resistant to antibiotics than other bacteria. MRSA sometimes makes people sick and other times people have the bacteria without getting sick. It is not known how often MRSA makes people with CF sick and whether it should be treated or not. This study is trying to learn more about MRSA treatment in people with CF.

People with CF, age 4 though 45 years, with a recent throat or sputum culture positive for MRSA for the first time, may be able to take part in the study. There will be two groups in this study. Participants in one group will receive the study treatment and participants in the other group will be observed. A computer will assign each person by chance (like flipping a coin) to one of the two groups.

Participants in the treatment group will take two antibiotics by mouth for 14 days, use nasal ointment, mouthwash and special skin wipes, and will be asked to use special wipes to clean surfaces at home. Participants in the observation group will continue with their usual CF care.

All participants will have three or four study visits in a six-week period after enrollment with two additional visits at three months and six months after enrollment.

Compensation for the visits required by the study and travel reimbursement will be provided.

Principal investigator

Ron Gibson, MD, PhD

Contact

Alan Genatossio, BSN, and Sharon McNamara, MN, 206-987-3921
Request more information  

Early Intervention in Cystic Fibrosis Exacerbation (eICE)

People with CF often have bacteria and mucus in their lungs, which can cause infection. Sometimes people wait many days or weeks before contacting the clinic about their increased symptoms of lung infection. This may make it harder to treat the lung infection. The goal of the study is to see if home monitoring of breathing tests and symptoms can help detect early lung infection. Early treatment of lung infection can help maintain healthy lungs.

People with CF who are 14 years of age and older may take part in this study. There will be two groups and participants will be randomly assigned (like flipping a coin) to a group.

Participants in one group will receive their usual care through the CF Clinic. Participants in the other group will continue to receive care through the CF Clinic, but will also use a home spirometer to perform lung function tests and fill out a symptom diary twice a week at home. The information is automatically sent to the study team for review it for any change in health.

Participants in both groups will be seen in the CF clinic every three months for routine care and will also complete study questionnaires. If symptoms of a lung infection develop, participants will be asked to come for additional clinic visits before antibiotics are started and again after completion of treatment. All participants will be enrolled in the study for 12 months.

Compensation for the visits required by the study will be provided.

Principal investigator

Ron Gibson, MD, PhD

Contact

Alan Genatossio, BSN, and Sharon McNamara, MN, 206-987-3921
Request more information  

Other CF Research at Children's

The EPIC Observational Study: Longitudinal Assessment of Risk Factors for and Impact of Pseudomonas

The EPIC Observational Study (EPIC Obs) is a prospective, longitudinal investigation of early CF lung disease. The study began in 2004, enrolling 1,800 children at 55 U.S. pediatric CF centers, and will continue until 2019. The purpose of the EPIC Obs study is to learn more about the factors that may lead to Pseudomonas aeruginosa (Pa) and Staphyloccocus aureus infections in children with CF. The information collected will also help investigator understand what happens to children with CF with regard to their treatment and health after Pa or Sa infection occurs. 

Visit the EPIC Obs study web page to learn more.