Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

Cystic Fibrosis Clinical Trial

Official title:

Effect of Proton Pump Inhibitors on CF Exacerbations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983774
• Other study ID #: AAAC5640
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: August 2011

Study information

• Verified date: January 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• Esomeprazole

• Placebo
Sugar pill

Locations

Country	Name	City	State
United States	Columbia University Cystic Fibrosis Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Forced Expiratory Volume in One Second (FEV1)	Forced Expiratory Volume in one second (FEV1) as measured by spirometry	36 weeks
Secondary	Forced Vital Capacity (FVC)	Forced Vital Capacity percent predicted	36 weeks
Secondary	Number of Exacerbations	Exacerbation defined as initiation of treatment with intravenous or oral antibiotics for 7 or more days based on respiratory symptoms	36 weeks

External Links

•   Results Reference