Completed

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

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What is being collected

Procedure Data

Collected from today forward - Prospective
ProcedureNo DNA Sample
Who is being recruted

Digestive System Diseases+5

+ Infant, Newborn, Diseases

+ Lung Diseases

From 8 to 75 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity of Florida
Last updated: October 14, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01815866
Principal SponsorUniversity of Florida
Last updated: October 14, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesInfant, Newborn, DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPancreatic DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCystic Fibrosis

Criteria

3 inclusion criteria required to participate
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
4 exclusion criteria prevent from participating
Forced Expiratory Volume at one second < 30% predicted
Hemoptysis greater than 1 tablespoon within the last 7 days
Pneumothorax within the last 6 months
Pregnancy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Florida Clinical Research Center

Gainesville, United StatesOpen University of Florida Clinical Research Center in Google Maps
CompletedOne Study Center