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Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Esomeprazole

Placebo

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring CF

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cystic fibrosis
Age > 18 years
Stable maintenance medical regimen during the previous 6 weeks.
Negative pregnancy test (women of childbearing potential) at both screening and baseline visits.
Women of childbearing potential must be using medically acceptable contraception.
At least two respiratory exacerbations per year requiring oral and/or intravenous antibiotics for each of the two years prior to study entry, but no more than 4 exacerbations requiring intravenous antibiotics during either of those years.

Exclusion Criteria:

Previous anti-reflux or peptic ulcer surgery,
Use of proton pump inhibitor (PPI) within the past two weeks
Pulmonary exacerbation requiring antibiotics within the previous 2 weeks
Parenteral hyperalimentation
Cigarette smoking
Treatment with azoles, iron, anti-coagulants, digitalis
Use of any investigative drugs within the previous month.
Use of over the counter acid suppressor agents (not including acid neutralizers)

Sites / Locations

Columbia University Cystic Fibrosis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Esomeprazole

Arm Description

A matching placebo (sugar pill) to esomeprazole 40mg twice daily

Esomeprazole 40mg twice daily

Outcomes

Primary Outcome Measures

Time to First Pulmonary Exacerbation

Time to need for oral or intravenous antibiotics for treatment of a pulmonary exacerbation is the primary outcome measure.

Secondary Outcome Measures

Forced Expiratory Volume in One Second (FEV1)

Forced Expiratory Volume in one second (FEV1) as measured by spirometry

Forced Vital Capacity (FVC)

Forced Vital Capacity percent predicted

Number of Exacerbations

Exacerbation defined as initiation of treatment with intravenous or oral antibiotics for 7 or more days based on respiratory symptoms

Full Information

NCT ID

NCT01983774

First Posted

November 6, 2013

Last Updated

January 25, 2022

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT01983774

Brief Title

Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Official Title

Effect of Proton Pump Inhibitors on CF Exacerbations

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Columbia University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Gastroesophageal reflux disease (GERD) is a common problem in cystic fibrosis (CF). It may lead to worsening lung function and more respiratory infections for a person with CF. This study will look at treating GERD with a medication, esomeprazole. The medication stops stomach acid from being made. The study will see if there are fewer respiratory infections and improved lung function in patients with CF when taking esomeprazole.

Detailed Description

This is a randomized, placebo controlled intervention study in patients with CF who have a history of frequent exacerbations. Treatment duration is 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

A matching placebo (sugar pill) to esomeprazole 40mg twice daily

Arm Title

Esomeprazole

Arm Type

Active Comparator

Arm Description

Esomeprazole 40mg twice daily

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Sugar pill

Primary Outcome Measure Information:

Title

Time to First Pulmonary Exacerbation

Description

Time to need for oral or intravenous antibiotics for treatment of a pulmonary exacerbation is the primary outcome measure.

Time Frame

36 weeks

Secondary Outcome Measure Information:

Title

Forced Expiratory Volume in One Second (FEV1)

Description

Forced Expiratory Volume in one second (FEV1) as measured by spirometry

Time Frame

36 weeks

Title

Forced Vital Capacity (FVC)

Description

Forced Vital Capacity percent predicted

Time Frame

36 weeks

Title

Number of Exacerbations

Description

Exacerbation defined as initiation of treatment with intravenous or oral antibiotics for 7 or more days based on respiratory symptoms

Time Frame

36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cystic fibrosis Age > 18 years Stable maintenance medical regimen during the previous 6 weeks. Negative pregnancy test (women of childbearing potential) at both screening and baseline visits. Women of childbearing potential must be using medically acceptable contraception. At least two respiratory exacerbations per year requiring oral and/or intravenous antibiotics for each of the two years prior to study entry, but no more than 4 exacerbations requiring intravenous antibiotics during either of those years. Exclusion Criteria: Previous anti-reflux or peptic ulcer surgery, Use of proton pump inhibitor (PPI) within the past two weeks Pulmonary exacerbation requiring antibiotics within the previous 2 weeks Parenteral hyperalimentation Cigarette smoking Treatment with azoles, iron, anti-coagulants, digitalis Use of any investigative drugs within the previous month. Use of over the counter acid suppressor agents (not including acid neutralizers)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emily DiMango, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Cystic Fibrosis Center

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33905540

Citation

Ng SM, Moore HS. Drug therapies for reducing gastric acidity in people with cystic fibrosis. Cochrane Database Syst Rev. 2021 Apr 27;4(4):CD003424. doi: 10.1002/14651858.CD003424.pub5.

Results Reference

derived

PubMed Identifier

32671834

Citation

Hurley MN, Smith S, Forrester DL, Smyth AR. Antibiotic adjuvant therapy for pulmonary infection in cystic fibrosis. Cochrane Database Syst Rev. 2020 Jul 16;7(7):CD008037. doi: 10.1002/14651858.CD008037.pub4.

Results Reference

derived

PubMed Identifier

24528942

Citation

Dimango E, Walker P, Keating C, Berdella M, Robinson N, Langfelder-Schwind E, Levy D, Liu X. Effect of esomeprazole versus placebo on pulmonary exacerbations in cystic fibrosis. BMC Pulm Med. 2014 Feb 15;14:21. doi: 10.1186/1471-2466-14-21.

Results Reference

derived

Links:

URL

https://bmcpulmmed.biomedcentral.com/articles/10.1186/1471-2466-14-21

Description

Results Reference

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Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

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