Cystic FibrosisNCT01815866
Cough-Generated Aerosols of NTM in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 75 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- CF with culturable NTM
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Specialialty Clinics, Pulmonary
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Florida Clinical Research Center
Gainesville, Florida, 32610
About this study
Official title: Cough-Generated Aerosols of Nontuberculous Mycobacteria in Patients With Cystic Fibrosis
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- CF with culturable NTM
- Keywords
- Positive Nontuberculous Mycobacteria
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CF with culturable NTMProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CF with culturable NTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Miracle Network, UF Peds
- Responsible party
- Sponsor
- Investigators
- Pamela M Schuler, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815866
- Sponsor's protocol ID
- 484-2012
- Status last verified
- Oct 2015
- First submitted
- 19 Mar 2013
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cough-Generated Aerosols of Nontuberculous Mycobacteria in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01815866
- Acronym / sponsor ID
- 484-2012
- Conditions
- Cystic Fibrosis
- Keywords
- Positive Nontuberculous Mycobacteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Children's Miracle Network, UF Peds
- Study start
- Apr 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF with culturable NTM | – | Procedure: CF with culturable NTMCF 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. |
Who may qualify
- Ages
- 8 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Specialialty Clinics, Pulmonary
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CF with culturable NTMCF 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. | Procedure or surgery | CF with culturable NTM |
Primary outcome
The number of CF patients who produce culturable aerosols of NTM during coughing.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pamela M Schuler, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of CF patients who produce culturable aerosols of NTM during coughing. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.