Scleroderma LungNCT01667042
Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
An observational study of Scleroderma Lung, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma Lung
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients seen at the Mayo Clinic in Florida with a confirmed diagnosis of systemic sclerosis (SSc) will be eligible.
Who may be able to join
- Adult patients ≥ 18 years old.
- Fulfilling the American College of Rheumatology criteria for SSc.
- For ILD subgroup (n=6):
- An upright chest-roentgenogram (chest x-ray) is abnormal and compatible with an interstitial lung disease.
- HRCT of the chest confirms the presence of bilateral reticular, ground glass, and/or honeycomb abnormalities that is otherwise unexplained by an alternative process
- The HRCT fibrosis score must be ≥ 7.
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- The total lung capacity (TLC, measured by body plethysmography) and/or the diffusing capacity of the lung for carbon monoxide (DLCO) is below the predicted normal.
- The forced vital capacity (FVC) is reduced below the predicted normal.
- The patient is symptomatic (i.e. dyspnea and/or a chronic cough) for more than 8 weeks that is otherwise unexplained by an alternative mechanism.
- For No ILD subgroup (n=6):
- No radiographic evidence of ILD on plain chest x-ray.
- The HRCT fibrosis score, when performed) must be < 7
- The TLC and FVC are within their predicted normal.
- The DLCO is within the predicted normal, except when reduced in isolation by pulmonary hypertension.
Who cannot join
- Active smoking within the 6 months.
- Pneumonia or bronchitis in past 4 weeks.
- Active acute illness such as uncontrolled heart failure, infection, or asthma.
- Use of more than 3 liters per minute (LPM) of oxygen by nasal cannula at rest.
- Coordinator, investigator, or clinician concerns on the patient's compliance, safety, or in ability to complete study requirements.
- Morbid condition not expected to live more than 1 year.
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- Alternative cause or diagnosis for the patient's ILD besides SSc.
- Pregnancy.
- Obstructive lung disease with an FEV1 (forced expiratory volume in 1 second) to FVC ratio less than 0.7, nor radiographic evidence of emphysema on CT.
- Planned therapeutic procedures involving the esophagus (e.g. dilation, surgery) prior to completion of study tests
Trial locations and contacts
1 site in 1 country.
About this study
This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).
- Conditions
- Scleroderma Lung
- Keywords
- Scleroderma Lung, Gastroesophageal Reflux, Microaspiration, Cough
- Medical subject headings
- Gastroesophageal Reflux, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Without Interstitial lung disease (ILD) | Not described | |
| With Interstitial lung disease (ILD) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway pepsin concentration
Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score
Measured: cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma LungStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Augustine S. Lee, Mayo Clinic
- Investigators
- Augustine Lee, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667042
- Sponsor's protocol ID
- 12-000304
- Status last verified
- Jan 2016
- First submitted
- 14 Aug 2012
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough
- ClinicalTrials.gov ID
- NCT01667042
- Acronym / sponsor ID
- 12-000304
- Conditions
- Scleroderma Lung
- Keywords
- Scleroderma Lung, Gastroesophageal Reflux, Microaspiration, Cough
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Aug 2012 (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.
This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Interstitial lung disease (ILD) | – | – |
| With Interstitial lung disease (ILD) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients seen at the Mayo Clinic in Florida with a confirmed diagnosis of systemic sclerosis (SSc) will be eligible.
Key inclusion criteria (14 listed)
- Adult patients ≥ 18 years old.
- Fulfilling the American College of Rheumatology criteria for SSc.
- For ILD subgroup (n=6):
- For No ILD subgroup (n=6):
Key exclusion criteria (10 listed)
- Active smoking within the 6 months.
- Pneumonia or bronchitis in past 4 weeks.
- Active acute illness such as uncontrolled heart failure, infection, or asthma.
- Use of more than 3 liters per minute (LPM) of oxygen by nasal cannula at rest.
- Coordinator, investigator, or clinician concerns on the patient's compliance, safety, or in ability to complete study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Airway pepsin concentration
Time frame: cross-sectional
Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score
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 8 Jan 2016.
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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.
Augustine Lee, M.D. principal investigator
Mayo Clinic
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 Scleroderma Lung, run by Mayo Clinic 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 14 inclusion and 10 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 8 Jan 2016. 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?
Airway pepsin concentration (time frame: cross-sectional). 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 8 Jan 2016.