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Completed

NCT Number: NCT01983774

Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University Cystic Fibrosis Center

New York, 10003, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Esomeprazole

Drug

Other names: Nexium

Placebo

Drug

Sugar pill

Primary outcomes

  1. Time to First Pulmonary Exacerbation

    Time frame: 36 weeks

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

Secondary outcomes

  1. Forced Expiratory Volume in One Second (FEV1)

    Time frame: 36 weeks

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

  2. Forced Vital Capacity (FVC)

    Time frame: 36 weeks

    Forced Vital Capacity percent predicted

  3. Number of Exacerbations

    Time frame: 36 weeks

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

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Effect of Proton Pump Inhibitors on CF Exacerbations

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 14, 2013
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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