Cough-Generated Aerosols of NTM in Cystic Fibrosis

Completed

• Conditions: Cystic Fibrosis
• Interventions: Procedure: CF with culturable NTM

• Registration Number: NCT01815866
• Lead Sponsor: University of Florida

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-21
• Study Start: 2013-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CF with culturable NTM	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.

Primary Outcome Measures

Name	Time	Method
The number of CF patients who produce culturable aerosols of NTM during coughing.	6 weeks	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.

Trial Locations

Locations (1)

University of Florida Clinical Research Center; 🇺🇸 Gainesville, Florida, United States