Cough-Generated Aerosols of NTM in Cystic Fibrosis

University of Florida

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Procedure: CF with culturable NTM

Study type: Observational

Funder types: Other

Identifiers

NCT01815866

484-2012

Details and patient eligibility

About

Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency. They have been demonstrated to cause clinically significant lung disease in some cases and the transmission of NTM, from person to person has been proposed. There are currently no standardized guidelines for isolation of those colonized or infected with NTM.

The investigators will measure particle droplet size from patients with CF who have positive sputum cultures for NTM with the hypothesis that they will be in a range that can spread infection.

Full description

Patients with a positive NTM sputum culture will be asked to participate in the study. If they agree to participate they will sign an informed consent and will be scheduled to come to the University of Florida Clinical Research Center for the testing.

The test will consist of the following: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.

Patients maybe asked to come back a second time if they develop a different type of NTM or start treatment for NTM.

Enrollment: 5 patients

Sex: All

Ages: 8 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age greater than or equal to age 8 years
• Confirmed Diagnosis of CF
• Sputum/Throat/Bronchoscopic culture positive for NTM within the last 12 months

Exclusion criteria

• Pregnancy
• Pneumothorax within the last 6 months
• Forced Expiratory Volume at one second <30% predicted
• Hemoptysis greater than 1 tablespoon within the last 7 days

Trial design

5 participants in 1 patient group

CF with culturable NTM

Description:

CF patients who produce culturable aerosols of NTM will receive the following test: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.

Treatment:

Procedure: CF with culturable NTM