Gastro Esophageal Reflux DisorderPhase 1NCT02584751
GERD and Anti-Reflux Therapy Between Able-bodied and SCI Individuals
A Phase 1 study testing Omeprazole, 24 Hour pH Monitor and Pulmonary Function Examination in people with Gastro Esophageal Reflux Disorder, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial summary
Respiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease (GERD) have been demonstrated to be highly prevalent in persons with SCI. GERD has been linked to respiratory symptoms and conditions such as asthma, chronic cough, and an increased rate of respiratory infections in the general… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux Disorder
- What is being tested?
- Omeprazole, 24 Hour pH Monitor and Pulmonary Function Examination
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2018
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with Tetraplegia (Level of SCI C4-8);
- Subjects with High Paraplegia (Level of SCI T1-T7);
- Subjects with Low Paraplegia (Level of SCI T8 or below);
- Able-Bodied Subjects (non SCI)
- Duration of injury ≥ 1 year; and
- Chronological age between 18-75 years.
Who cannot join
- Smoking, active or history of smoking < 6 months;
- Any history of blast injuries to the chest;
- Active respiratory disease or recent (within 3 months) respiratory infections;
- Use of medications known to alter airway caliber (i.e. beta 2 agonists or anticholinergic agents);
- Use of Protein Pump Inhibitors < 8 weeks before testing;
- Use of H2 receptor blockers <8 weeks before testing;
- History of gastrectomy;
- History of esophageal malignancy and/or resection
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
James J. Peters VA Medical Center
The Bronx, New York, 10468
Tradd Cummings, MS, 718-584-9000 ext. 3107, tradd.cummings@va.gov
Josh Hobson, MS, (718) 584-9000 ext. 3129, joshua.hobson@va.gov
About this study
Official title: Comparison of GERD and the Effects of Anti-Reflux Therapy on Pulmonary Function Between Able-Bodied and SCI Individuals
Respiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease (GERD) have been demonstrated to be highly prevalent in persons with SCI. GERD has been linked to respiratory symptoms and conditions such as asthma, chronic cough, and an increased rate of respiratory infections in the general population. In persons with asthma, respiratory symptoms and dependency on asthma medications have been reduced by treatment with anti-reflux medication. Possible mechanisms have been proposed for this link, including the microaspiration of reflux materials, which may result in airway acidification and aspiration pneumonia, or the stimulation of the vagus nerve through acid-sensitive receptors in the esophagus with associated esophageal inflammation and reflex bronchoconstriction. Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in persons with SCI on objective and subjective symptoms of respiratory function to determine the underlying mechanisms of airway inflammation due to GERD.
Read the detailed description
Complete or partial loss of respiratory muscle innervation in individuals with cervical (C1-8) and high thoracic (T1-6) injuries leads to inadequate ventilation and inability to effectively clear secretions, often prompting supportive ventilation following initial injury. Development of atelectasis, pneumonias and respiratory failure are the most common respiratory complications observed during the acute phase of injury. The role of chronic airway inflammation on pulmonary function in persons with SCI is unknown, although the investigators' recent work has shown that individuals with cervical SCI have elevated levels of exhaled nitric oxide (NO), comparable to those seen in mild asthma. It is now widely believed that in the airways of asthmatic patients, the release of NO represents a physiological mechanism to counteract the bronchoconstriction caused by various stimuli. In persons with cervical SCI, bronchoconstriction may represent a consequence of unopposed parasympathetic influence, but alternative mechanisms, such as recurrent infections secondary to impaired cough effectiveness, systemic inflammatory response following SCI, or extra-esophageal manifestations of underlying esophageal dysmotility and/or GERD need to be evaluated. In general population, it has been long recognized that esophageal dysmotility and/or GERD may lead to extra-esophageal manifestations. Reflux can affect both upper and lower respiratory systems leading to the variety of extra-esophageal manifestations, such as reflux asthma, chronic cough, hoarseness, chronic sinusitis, laryngitis, loss of dental enamel, idiopathic pulmonary fibrosis, recurrent pneumonia, chronic bronchitis, etc. 2 possible mechanisms of these complications have been identified: the direct aspiration of reflux content and indirectly, stimulation of vagally-mediated reflexes. Regardless of the underlying mechanisms, treatments with acid-reducing therapies have shown improvement in GERD and extra-esophageal manifestations of the disease the general population. Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in persons with SCI on objective and subjective symptoms of respiratory function to determine the underlying mechanisms of airway inflammation due to GERD.
- Conditions
- Gastro Esophageal Reflux Disorder
- Being tested
- Omeprazole, 24 Hour pH Monitor, Pulmonary Function Examination, Exhaled Nitric Oxide, Exhaled Breath Concentrate (EBC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Omeprazole is a commonly prescribed anti-reflux medication. If a SCI patient has GERD, they will be prescribed with 40mg omeprazole twice daily for two months
24 Hour pH MonitorDevice
Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD
Pulmonary Function ExaminationProcedure or surgery
Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.
Exhaled Nitric OxideProcedure or surgery
Used to measure inflammation markers for airway resistance.
Exhaled Breath Concentrate (EBC)Procedure or surgery
EBC will be used to measure airway inflammation via specific markers, such as 8-isoprostane. This marker, if elevated, has been identified as an indicator for asthma inflammation.
Bernstein's Acid Clearance TestProcedure or surgery
Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure
Esophageal MotilityProcedure or surgery
Esophageal Motility will be used to measure a subject's ability to swallow a bolus (i.e. saline solution) and record pressure changes throughout the esophagus during the swallow. This will also be used to identify anatomical landmarks, such as lower esophageal sphincter, which are necessary for proper placement of 24hr pH catheter.
| Study group | Role | What they receive |
|---|---|---|
| Able-Bodied non-GERD | Active comparator | Able-bodied patients who are not diagnosed with GERD during screening will act as controls. Receives: Device: 24 Hour pH Monitor; Procedure: Pulmonary Function Examination; Procedure: Exhaled Nitric Oxide; Procedure: Exhaled Breath Concentrate (EBC); Procedure: Bernstein's Acid Clearance Test; Procedure: Esophageal Motility |
| SCI non-GERD | Active comparator | SCI patients who are not diagnosed with GERD during screening will act as controls Receives: Device: 24 Hour pH Monitor; Procedure: Pulmonary Function Examination; Procedure: Exhaled Nitric Oxide; Procedure: Exhaled Breath Concentrate (EBC); Procedure: Bernstein's Acid Clearance Test; Procedure: Esophageal Motility |
| SCI GERD | Experimental | For those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD Receives: Drug: Omeprazole; Device: 24 Hour pH Monitor; Procedure: Pulmonary Function Examination; Procedure: Exhaled Nitric Oxide; Procedure: Exhaled Breath Concentrate (EBC); Procedure: Bernstein's Acid Clearance Test; Procedure: Esophageal Motility |
| Able-bodied GERD | Active comparator | For those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. Receives: Device: 24 Hour pH Monitor; Procedure: Pulmonary Function Examination; Procedure: Exhaled Nitric Oxide; Procedure: Exhaled Breath Concentrate (EBC); Procedure: Bernstein's Acid Clearance Test; Procedure: Esophageal Motility |
What is being measured
The primary outcome is the main question the study is designed to answer.
DeMeester Score
A DeMeester score will be calculated from the 24hour pH monitoring to determine if an individual has GERD.
Measured: 24hours
Secondary outcomes (2)
Pulmonary Function Tests
Pulmonary Function values and results will be compared to one another to determine if a protein pump inhibitor treatment decreases GERD and improves pulmonary function
Measured: 2days
Symptom Surveys and Questionnaires
An 11 question survey assessing GERD and a 15 question survey assessing dysphagia or difficulty swallowing will be used to confirm diagnosis of GERD and compared across the various groups.
Measured: 2days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal Reflux DisorderStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Miroslav Radulovic, M.D., James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584751
- Sponsor's protocol ID
- RAD-16-02
- Status last verified
- Nov 2016
- First submitted
- 9 Oct 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of GERD and the Effects of Anti-Reflux Therapy on Pulmonary Function Between Able-Bodied and SCI Individuals
- ClinicalTrials.gov ID
- NCT02584751
- Acronym / sponsor ID
- RAD-16-02
- Conditions
- Gastro Esophageal Reflux Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- First posted
- 23 Oct 2015 (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.
Respiratory dysfunction, esophageal dysmotility, and a gastroesophageal reflux disease (GERD) have been demonstrated to be highly prevalent in persons with SCI. GERD has been linked to respiratory symptoms and conditions such as asthma, chronic cough, and an increased rate of respiratory infections in the general population. In persons with asthma, respiratory symptoms and dependency on asthma medications have been reduced by treatment with anti-reflux medication. Possible mechanisms have been proposed for this link, including the microaspiration of reflux materials, which may result in airway acidification and aspiration pneumonia, or the stimulation of the vagus nerve through acid-sensitive receptors in the esophagus with associated esophageal inflammation and reflex bronchoconstriction. Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in persons with SCI on objective and subjective symptoms of respiratory function to determine the underlying mechanisms of airway inflammation due to GERD.
Detailed description
Complete or partial loss of respiratory muscle innervation in individuals with cervical (C1-8) and high thoracic (T1-6) injuries leads to inadequate ventilation and inability to effectively clear secretions, often prompting supportive ventilation following initial injury. Development of atelectasis, pneumonias and respiratory failure are the most common respiratory complications observed during the acute phase of injury. The role of chronic airway inflammation on pulmonary function in persons with SCI is unknown, although the investigators' recent work has shown that individuals with cervical SCI have elevated levels of exhaled nitric oxide (NO), comparable to those seen in mild asthma. It is now widely believed that in the airways of asthmatic patients, the release of NO represents a physiological mechanism to counteract the bronchoconstriction caused by various stimuli. In persons with cervical SCI, bronchoconstriction may represent a consequence of unopposed parasympathetic influence, but alternative mechanisms, such as recurrent infections secondary to impaired cough effectiveness, systemic inflammatory response following SCI, or extra-esophageal manifestations of underlying esophageal dysmotility and/or GERD need to be evaluated. In general population, it has been long recognized that esophageal dysmotility and/or GERD may lead to extra-esophageal manifestations. Reflux can affect both upper and lower respiratory systems leading to the variety of extra-esophageal manifestations, such as reflux asthma, chronic cough, hoarseness, chronic sinusitis, laryngitis, loss of dental enamel, idiopathic pulmonary fibrosis, recurrent pneumonia, chronic bronchitis, etc. 2 possible mechanisms of these complications have been identified: the direct aspiration of reflux content and indirectly, stimulation of vagally-mediated reflexes. Regardless of the underlying mechanisms, treatments with acid-reducing therapies have shown improvement in GERD and extra-esophageal manifestations of the disease the general population. Investigators propose to study the effects of anti-reflux therapy (proton pump inhibition) in persons with SCI on objective and subjective symptoms of respiratory function to determine the underlying mechanisms of airway inflammation due to GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Able-Bodied non-GERD | Active comparator | Device: 24 Hour pH Monitor, Procedure: Pulmonary Function Examination, Procedure: Exhaled Nitric Oxide, Procedure: Exhaled Breath Concentrate (EBC), Procedure: Bernstein's Acid Clearance Test, Procedure: Esophageal MotilityAble-bodied patients who are not diagnosed with GERD during screening will act as controls. |
| SCI non-GERD | Active comparator | Device: 24 Hour pH Monitor, Procedure: Pulmonary Function Examination, Procedure: Exhaled Nitric Oxide, Procedure: Exhaled Breath Concentrate (EBC), Procedure: Bernstein's Acid Clearance Test, Procedure: Esophageal MotilitySCI patients who are not diagnosed with GERD during screening will act as controls |
| SCI GERD | Experimental | Drug: Omeprazole, Device: 24 Hour pH Monitor, Procedure: Pulmonary Function Examination, Procedure: Exhaled Nitric Oxide, Procedure: Exhaled Breath Concentrate (EBC), Procedure: Bernstein's Acid Clearance Test, Procedure: Esophageal MotilityFor those SCI subjects who are identified with GERD, they will undergo a 8week treatment of Omeprazole to reduce GERD |
| Able-bodied GERD | Active comparator | Device: 24 Hour pH Monitor, Procedure: Pulmonary Function Examination, Procedure: Exhaled Nitric Oxide, Procedure: Exhaled Breath Concentrate (EBC), Procedure: Bernstein's Acid Clearance Test, Procedure: Esophageal MotilityFor those AB subjects who are identified with GERD will act as controls. Note they will not receive treatment for GERD in this study. We will notify their primary care physician during the study so that they may receive treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with Tetraplegia (Level of SCI C4-8);
- Subjects with High Paraplegia (Level of SCI T1-T7);
- Subjects with Low Paraplegia (Level of SCI T8 or below);
- Able-Bodied Subjects (non SCI)
- Duration of injury ≥ 1 year; and
Key exclusion criteria (8 listed)
- Smoking, active or history of smoking < 6 months;
- Any history of blast injuries to the chest;
- Active respiratory disease or recent (within 3 months) respiratory infections;
- Use of medications known to alter airway caliber (i.e. beta 2 agonists or anticholinergic agents);
- Use of Protein Pump Inhibitors < 8 weeks before testing;
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 |
|---|---|---|
| OmeprazoleOmeprazole is a commonly prescribed anti-reflux medication. If a SCI patient has GERD, they will be prescribed with 40mg omeprazole twice daily for two months | Drug | SCI GERD |
| 24 Hour pH MonitorMonitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD | Device | Able-Bodied non-GERD, Able-bodied GERD, SCI GERD, SCI non-GERD |
| Pulmonary Function ExaminationAssess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures. | Procedure or surgery | Able-Bodied non-GERD, Able-bodied GERD, SCI GERD, SCI non-GERD |
| Exhaled Nitric OxideUsed to measure inflammation markers for airway resistance. | Procedure or surgery | Able-Bodied non-GERD, Able-bodied GERD, SCI GERD, SCI non-GERD |
| Exhaled Breath Concentrate (EBC)EBC will be used to measure airway inflammation via specific markers, such as 8-isoprostane. This marker, if elevated, has been identified as an indicator for asthma inflammation. | Procedure or surgery | Able-Bodied non-GERD, Able-bodied GERD, SCI GERD, SCI non-GERD |
| Bernstein's Acid Clearance TestBernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure | Procedure or surgery | Able-Bodied non-GERD, Able-bodied GERD, SCI GERD, SCI non-GERD |
| Esophageal MotilityEsophageal Motility will be used to measure a subject's ability to swallow a bolus (i.e. saline solution) and record pressure changes throughout the esophagus during the swallow. This will also be used to identify anatomical landmarks, such as lower esophageal sphincter, which are necessary for proper placement of 24hr pH catheter. | Procedure or surgery | Able-Bodied non-GERD, Able-bodied GERD, SCI GERD, SCI non-GERD |
Primary outcome
DeMeester Score
Time frame: 24hours
A DeMeester score will be calculated from the 24hour pH monitoring to determine if an individual has GERD.
2 secondary outcomes
Pulmonary Function Tests
Time frame: 2days
Symptom Surveys and Questionnaires
Time frame: 2days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeprazole, 24 Hour pH Monitor and Pulmonary Function Examination in people with Gastro Esophageal Reflux Disorder, run by James J. Peters Veterans Affairs Medical Center 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Nov 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miroslav Radulovic, MD (718-584-9000 ext. 5472, miroslav.radulovic@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DeMeester Score (time frame: 24hours). 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 15 Nov 2016.