Clinical trial NCT01983774: Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations
Official title: Effect of Proton Pump Inhibitors on CF Exacerbations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Keywords: CF
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Cystic fibrosis
2. Age \> 18 years
3. Stable maintenance medical regimen during the previous 6 weeks.
4. Negative pregnancy test (women of childbearing potential) at both screening and baseline visits.
5. Women of childbearing potential must be using medically acceptable contraception.
6. 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:

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

Primary outcomes:
measure: Time to First Pulmonary Exacerbation
timeFrame: 36 weeks
Secondary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: 36 weeks
measure: Forced Vital Capacity (FVC)
timeFrame: 36 weeks
measure: Number of Exacerbations
timeFrame: 36 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Cystic Fibrosis Center
state: New York
Study officials:
affiliation: Columbia University
name: Emily DiMango, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.