Trial Outcomes & Findings for COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI (NCT NCT00523367)
NCT ID: NCT00523367
Last Updated: 2013-01-18
Results Overview
The number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.
TERMINATED
NA
25 participants
1 year
2013-01-18
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
19 screen failures
|
19
|
|
Overall Study
4 Withdrawn by PI
|
4
|
Baseline Characteristics
COPD Patients Diagnosed With GERD,COPD Exacerbations After Treatment With High Dose PPI
Baseline characteristics by cohort
| Measure |
COPD Patients With GERD Symptoms
n=25 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Age Continuous
|
59.16 years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe number of participants who have Gastro Esophageal Reflux Disease after one year of treatment.
Outcome measures
| Measure |
COPD Patients With GERD Symptoms
n=2 Participants
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.
|
|---|---|
|
Number of Participants With Gastro Esophageal Reflux Disease One Year After Treatment.
|
0 participants
|
SECONDARY outcome
Timeframe: 1 yearCOPD patients with GERD treated with high dose esomeprazole for 1 year decreases the frequency of COPD exacerbations compared to the previous year without treatment.
Outcome measures
Outcome data not reported
Adverse Events
COPD Patients With GERD Symptoms
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
COPD Patients With GERD Symptoms
n=25 participants at risk
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.
|
|---|---|
|
General disorders
Cough
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Shortness of breath
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Sore throat
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Chest pain
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Nausea
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Increased COPD
|
8.0%
2/25 • Number of events 2
|
|
General disorders
Flu symptoms
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Hemoptysis
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Bronchitis
|
4.0%
1/25 • Number of events 2
|
|
General disorders
Dizziness
|
4.0%
1/25 • Number of events 1
|
|
General disorders
Sinusitis
|
4.0%
1/25 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place