Cystic FibrosisPhase 2NCT01983774

Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations

A Phase 2 study testing Esomeprazole in people with Cystic Fibrosis, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cystic Fibrosis
What is being tested?: Esomeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Aug 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Columbia University Cystic Fibrosis Center
New York, New York, 10003

Other trials in United States

About this study

Official title: Effect of Proton Pump Inhibitors on CF Exacerbations

Read the 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.

Conditions: Cystic Fibrosis
Being tested: Esomeprazole, Placebo
Keywords: CF
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsomeprazoleDrug
Also called Nexium
PlaceboDrug
Sugar pill

Study groups in NCT01983774
Study group	Role	What they receive
Placebo	Placebo comparator	A matching placebo (sugar pill) to esomeprazole 40mg twice daily Receives: Drug: Placebo
Esomeprazole	Active comparator	Esomeprazole 40mg twice daily Receives: Drug: Esomeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to First Pulmonary Exacerbation
Time to need for oral or intravenous antibiotics for treatment of a pulmonary exacerbation is the primary outcome measure.
Measured: 36 weeks

Secondary outcomes (3)

Forced Expiratory Volume in One Second (FEV1)
Forced Expiratory Volume in one second (FEV1) as measured by spirometry
Measured: 36 weeks
Forced Vital Capacity (FVC)
Forced Vital Capacity percent predicted
Measured: 36 weeks
Number of Exacerbations
Exacerbation defined as initiation of treatment with intravenous or oral antibiotics for 7 or more days based on respiratory symptoms
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Aug 2011

First posted14 Nov 2013 (estimated)
Study startFeb 2008
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01983774
Sponsor's protocol ID: AAAC5640
Status last verified: Jan 2022
First submitted: 6 Nov 2013
Last updated: 17 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 33905540
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.
PubMed 32671834
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.
PubMed 24528942

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Proton Pump Inhibitors on CF Exacerbations
ClinicalTrials.gov ID: NCT01983774
Acronym / sponsor ID: AAAC5640
Conditions: Cystic Fibrosis
Keywords: CF
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Study start: Feb 2008
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 14 Nov 2013 (estimated)
Results: Posted 17 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboA matching placebo (sugar pill) to esomeprazole 40mg twice daily
Esomeprazole	Active comparator	Drug: EsomeprazoleEsomeprazole 40mg twice daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EsomeprazoleAlso: Nexium	Drug	Esomeprazole
PlaceboSugar pill	Drug	Placebo

Primary outcome

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.

3 secondary outcomes

Forced Expiratory Volume in One Second (FEV1)
Time frame: 36 weeks
Forced Vital Capacity (FVC)
Time frame: 36 weeks
Number of Exacerbations
Time frame: 36 weeks

Results and safety

Results posted to the registry on 17 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esomeprazole	9	8
Placebo	8	7

Primary outcome: Time to First Pulmonary Exacerbation

Time frame: 36 weeks. Mean (Standard Deviation). Unit: Weeks

Measure	Esomeprazole n = 9	Placebo n = 8
Value	NA (NA)	NA (NA)

Population analysed: Values per arm for time to first pulmonary exacerbation cannot be reported. The data set was destroyed and no longer exists. The only available results exist as a figure within the study publication.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Placebo	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Limitations and caveats (from the sponsor): Study findings are limited by small sample size without adequate power to detect significant differences between participants treated with esomeprazole compared with placebo.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33905540Ng 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.
Derived from this study: PubMed 32671834Hurley 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.
Derived from this study: PubMed 24528942Dimango 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 ReferenceLink provided by the sponsor.

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RecruitingPhase 2
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Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emily DiMango, MD principal investigator

Columbia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Esomeprazole in people with Cystic Fibrosis, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Pulmonary Exacerbation (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01983774, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.