Chronic Obstructive Pulmonary Disease, Gastroesophageal Reflux
Conditions
Keywords
Gastro Esophageal Reflux Disease (GERD), Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
The purpose of this study is to determine which COPD patients have GERD and if COPD patients with GERD treated with high dose lansoprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.
Detailed description
Gastroesophageal reflux disease (GERD) is a common esophageal disorder with 40% of the US adult population experiencing symptoms monthly. Pulmonary diseases associated with GERD may include pneumonia, pulmonary fibrosis, asthma, or chronic bronchitis. The latter may be a manifestation of chronic obstructive pulmonary disease (COPD), suggesting GERD as a risk factor for acute exacerbation of COPD. Acute exacerbations of COPD are a major cause of morbidity and mortality in patients with the disease. Recent work suggests that COPD patients with a minimum of weekly reflux symptoms have an increased number of COPD exacerbations that those who are either asymptomatic or have GERD symptoms less than once a week. On this basis, we theorized that in patients with COPD, who also have gastro esophageal reflux disease are at increase risk for acute exacerbations of COPD. To test this question, we will determine which COPD patients have GERD by 24 hour pH testing, treat their GERD with esomeprazole or lansoprazole for 1 year, and compare the number of COPD exacerbations during the treatment period to the previous year.
Interventions
PROCEDURE24 hour pH testing
24 hour pH testing will be used to screen patients
Sponsors
Takeda
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of COPD * forced expiratory volume/forced vital capacity ratio (FEV1/FVC) of \< 70% on pulmonary function testing * age \> 40 years * \>20 pack year history of smoking
Exclusion criteria
* presence of the following disorders: respiratory disorders other than COPD, known esophageal disease such as cancer, achalasia, stricture, active peptic ulcer disease, Zollinger-Ellison syndrome, mastocytosis, scleroderma, or current abuse of alcohol defined as greater than three alcoholic drinks per day.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment. | 1 year | The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COPD/GERD Patients Treated With High Dose Esomeprazole | 1 year | COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment. |
Countries
United States
Participant flow
Recruitment details
A flyer was posted in the pulmonary clinic which provides basic information about the trial and instructs the reader to ask their doctor for more information. Interested patients were referred to the Gastroenterology Clinic where they were consented and screened.
Pre-assignment details
Eligible patients with a known diagnosis of COPD and pulmonary function testing meeting criteria were asked to complete a validated GERD and quality of life questionnaire. These questionnaires are queried for GERD symptoms and an assessment of overall health during the previous year.
Participants by arm
| Arm | Count |
|---|---|
| COPD Patients With GERD Symptoms Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 19 screen failures | 19 |
| Overall Study | 4 Withdrawn by PI | 4 |
Baseline characteristics
| Characteristic | COPD Patients With GERD Symptoms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Age Continuous | 59.16 years STANDARD_DEVIATION 11.81 |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.
The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COPD Patients With GERD Symptoms | Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment. | 0 participants |
Secondary
COPD/GERD Patients Treated With High Dose Esomeprazole
COPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.
Time frame: 1 year