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| ID | Type | Description | Link |
|---|---|---|---|
| 1UM1HL119089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This study will test the hypothesis that treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal reflux (GER) will slow the decline of forced vital capacity (FVC) over 48 weeks.
This protocol proposes to test the following hypothesis: Treatment with laparoscopic anti-reflux surgery in subjects with idiopathic pulmonary fibrosis (IPF) and abnormal gastroesophageal (GER) reflux will slow the decline of forced vital capacity (FVC) over 48 weeks. This study will randomize approximately 58 subjects with IPF and abnormal acid reflux on 24-hour impedance / pH monitoring to laparoscopic anti-reflux surgery or standard care (randomization ratio 1:1). Subjects will be followed for 48 weeks or until the time of lung transplantation or death.
We aim to achieve the following: determine the impact of laparoscopic anti-reflux surgery on change in FVC over 48 weeks in patients with IPF and abnormal GER; correlate the reduction in acid and non-acid reflux events with the change in FVC over 48 weeks in patients with IPF and abnormal GER; determine the safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER; explore the impact of laparoscopic anti-reflux surgery on key secondary endpoints over 48 weeks in patients with IPF and abnormal GER; identify molecular markers of IPF disease activity and gastroesophageal reflux in biological samples from patients with IPF and abnormal GER.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Subjects to receive standard anti-reflux treatment per clinical discretion | |
| Surgery | Active Comparator | Subjects will receive laparoscopic fundoplication surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | Full fundoplication surgery for the treatment of abnormal GER |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Vital Capacity (FVC) | Change in FVC (in liters) between enrollment and 48 weeks. | Baseline and 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks | Change in acid and non-acid reflux events from baseline to week 48. All subjects answered questions related to their reflux using a Likert scale (0 = never, 1 =occasionally, 2 = sometimes, 3 = often, 4 = always). | Baseline and 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harold R Collard, MD | University of California, San Francisco | Principal Investigator |
| Ganesh Raghu, MD | University of Washington | Principal Investigator |
| Kevin J Anstrom, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | San Francisco | California | United States | |||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30100404 | Result | Raghu G, Pellegrini CA, Yow E, Flaherty KR, Meyer K, Noth I, Scholand MB, Cello J, Ho LA, Pipavath S, Lee JS, Lin J, Maloney J, Martinez FJ, Morrow E, Patti MG, Rogers S, Wolters PJ, Yates R, Anstrom KJ, Collard HR. Laparoscopic anti-reflux surgery for the treatment of idiopathic pulmonary fibrosis (WRAP-IPF): a multicentre, randomised, controlled phase 2 trial. Lancet Respir Med. 2018 Sep;6(9):707-714. doi: 10.1016/S2213-2600(18)30301-1. Epub 2018 Aug 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Subjects to receive standard anti-reflux treatment per clinical discretion |
| FG001 | Surgery | Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Subjects to receive standard anti-reflux treatment per clinical discretion |
| BG001 | Surgery | Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Forced Vital Capacity (FVC) | Change in FVC (in liters) between enrollment and 48 weeks. | Randomized patients | Posted | Mean | 95% Confidence Interval | liters | Baseline and 48 weeks |
|
48 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Subjects to receive standard anti-reflux treatment per clinical discretion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Worsening | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dysphagia | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harold Collard, MD | University of California, San Francisco | 415 4761000 | Harold.Collard@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2016 | Sep 2, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2016 | Sep 2, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D018662 | Fundoplication |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
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| Safety of Laparoscopic Anti-reflux Surgery |
Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER as measured by number of participants who experienced death, serious adverse event, or other (not including serious) adverse event. See Adverse Events section for additional details. |
| 48 weeks |
| All-cause Mortality | Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks | 48 weeks |
| Non-elective Hospitalization | Impact on non-elective hospitalizations from baseline to 48 weeks. | Baseline and 48 weeks |
| Acute Exacerbations | Impact on acute exacerbations of IPF from baseline to week 48. | Baseline and 48 weeks |
| University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score | Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness. | Baseline and 48 weeks |
| St. George's Respiratory Questionnaire (SGRQ) Score | Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations. | Baseline and 48 weeks |
| 6-minute Walk Distance | Change in 6-minute walk distance from baseline to week 48 | Baseline and 48 weeks |
| Cough Visual Analog Scale (VAS) | Change in VAS from baseline to week 48. The scale range is 1-100. Lower scores indicate no cough and 100 indicates the worst cough. | Baseline and 48 weeks |
| High-Resolution CT (HRCT) Fibrosis Score. | Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis. | Baseline to 48 weeks |
| Chicago |
| Illinois |
| United States |
| University of Michigan | Ann Arbor | Michigan | United States |
| University of Washington | Seattle | Washington | United States |
| University of Wisconsin | Madison | Wisconsin | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change in Score From Baseline for Acid and Non-acid Reflux Events at 48 Weeks | Change in acid and non-acid reflux events from baseline to week 48. All subjects answered questions related to their reflux using a Likert scale (0 = never, 1 =occasionally, 2 = sometimes, 3 = often, 4 = always). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 48 weeks |
|
|
|
| Secondary | Safety of Laparoscopic Anti-reflux Surgery | Overall safety of laparoscopic anti-reflux surgery in patients with IPF and abnormal GER as measured by number of participants who experienced death, serious adverse event, or other (not including serious) adverse event. See Adverse Events section for additional details. | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | All-cause Mortality | Impact of anti-reflux surgery on all-cause mortality from enrollment to 48 weeks | Posted | Count of Participants | Participants | 48 weeks |
|
|
|
| Secondary | Non-elective Hospitalization | Impact on non-elective hospitalizations from baseline to 48 weeks. | Posted | Count of Participants | Participants | Baseline and 48 weeks |
|
|
|
| Secondary | Acute Exacerbations | Impact on acute exacerbations of IPF from baseline to week 48. | Posted | Count of Participants | Participants | Baseline and 48 weeks |
|
|
|
| Secondary | University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOQB) Score | Change in UCSD SOQB score from baseline to week 48. The score range is 0-120. Higher scores indicate higher breathlessness. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 48 weeks |
|
|
|
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Score | Change in SGRQ score from baseline to week 48. The score range is 0-100. Higher scores indicate more limitations. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 48 weeks |
|
|
|
| Secondary | 6-minute Walk Distance | Change in 6-minute walk distance from baseline to week 48 | Posted | Mean | 95% Confidence Interval | meters | Baseline and 48 weeks |
|
|
|
| Secondary | Cough Visual Analog Scale (VAS) | Change in VAS from baseline to week 48. The scale range is 1-100. Lower scores indicate no cough and 100 indicates the worst cough. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 48 weeks |
|
|
|
| Secondary | High-Resolution CT (HRCT) Fibrosis Score. | Change in HRCT fibrosis score from baseline to week 48. HRCT Fibrosis score is calculated as a percentage. Higher percentage indicates more fibrosis. | Data are not available to be reported due to inability to obtain imaging data on participants and generate a score. | Posted | Baseline to 48 weeks |
|
|
| 4 |
| 29 |
| 8 |
| 29 |
| 0 |
| 29 |
| EG001 | Surgery | Subjects will receive laparoscopic fundoplication surgery Surgery: Full fundoplication surgery for the treatment of abnormal GER | 1 | 29 | 5 | 29 | 9 | 29 |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| acute myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| cardiac disorder | Cardiac disorders | Systematic Assessment |
|
| myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| gastrointestinal haemorrhave | Gastrointestinal disorders | Systematic Assessment |
|
| intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
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| bile duct obstruction | Hepatobiliary disorders | Systematic Assessment |
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| cholecytitis | Gastrointestinal disorders | Systematic Assessment |
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| pneumonia | Infections and infestations | Systematic Assessment |
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| sepsis | Infections and infestations | Systematic Assessment |
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| anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| carotid artery stenosis | Nervous system disorders | Systematic Assessment |
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| shock | Vascular disorders | Systematic Assessment |
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| abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| flatulence | Gastrointestinal disorders | Systematic Assessment |
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| gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| gastrointestinal motility disorder | Gastrointestinal disorders | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| Do you get bitter liquid (acid) in throat? |
|
| Do you burp a lot? |
|
| Other (Not Including Serious) Adverse Events |
|