Cough-Generated Aerosols of NTM in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Cough-Generated Aerosols of Nontuberculous Mycobacteria in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815866
• Other study ID #: 484-2012
• Status: Completed
• Phase: N/A
• First received: March 19, 2013
• Last updated: October 13, 2015
• Start date: April 2013
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Procedure:
• CF with culturable NTM
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.

Locations

Country	Name	City	State
United States	University of Florida Clinical Research Center	Gainesville	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Florida	Children's Miracle Network, UF Peds

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of CF patients who produce culturable aerosols of NTM during coughing.	Patients with CF and a positive sputum or bronchoalveolar lavage (BAL) culture for NTM will cough into a chamber filled with culture plates that can measure droplet size. The investigators are looking for large droplets, that could land on surfaces and be a source for infection transmission, as well as fine droplets(5 microns or less)that are consistent with airborne transmission.	6 weeks	Yes