Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

NCT01983774 | Completed Phase 2 Results DMC

• 1 other identifier: AAAC5640
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

CF

Outcome Measures

Primary Outcomes (1)

• Time to First Pulmonary Exacerbation

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

  36 weeks

Secondary Outcomes (3)

• Forced Expiratory Volume in One Second (FEV1)

  36 weeks

• Forced Vital Capacity (FVC)

  36 weeks

• Number of Exacerbations

  36 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Esomeprazole

ACTIVE COMPARATOR

Esomeprazole 40mg twice daily

Drug: Esomeprazole

Interventions

Esomeprazole DRUG

Also known as: Nexium

Esomeprazole

Placebo DRUG

Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Cystic Fibrosis Center

New York, New York, 10003, United States

Location

Related Publications (3)

• 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.

  PMID: 33905540 DERIVED

• 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.

  PMID: 32671834 DERIVED

• 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.

  PMID: 24528942 DERIVED

Related Links

• Results Reference

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Study findings are limited by small sample size without adequate power to detect significant differences between participants treated with esomeprazole compared with placebo.

Results Point of Contact

• Title: Emily DiMango, MD
• Organization: Columbia University

ead3@cumc.columbia.edu

212-305-0631

Study Officials

• Emily DiMango, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: November 14, 2013
• Study Start: February 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2022-01

Locations

US (1)