Cough-Generated Aerosols of NTM in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CF with culturable NTM

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No