Cystic FibrosisNCT00577499
Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis
An observational study of Cystic Fibrosis and Constipation, run by University of Arkansas.
Trial summary
Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency, and achieving and maintaining adequate nutrition is an important goal of therapy because it is positively correlated with lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Constipation, Nutrition
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult cystic fibrosis clinic
Who may be able to join
- Planning or currently on chronic lubiprostone therapy (chronic is defined as at least one 24 microgram capsule by mouth every other day
- Body mass index (BMI) of less than 22 for females and less than 23 for males at the initiation of chronic lubiprostone therapy
- Initiation of chronic lubiprostone therapy within 1 month of enrollment
- Age over 18
- Currently taking a multivitamin
Who cannot join
- History of noncompliance with medications and other CF therapies
- History of hospital admissions for CF exacerbations of ≥2 in the last 6 months
- FEV1 les than 40% of expected (severe dysfunction) at most recent assessment in the ambulatory setting
- Currently registered on a lung transplant waiting list
- Any other condition, in the opinion of the investigators, that interferes with the ability of the study subject to comply with study requirements, confers significant risk, or limits the ability of the subject to complete the study
About this study
Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency, and achieving and maintaining adequate nutrition is an important goal of therapy because it is positively correlated with lung function. Lubiprostone activates chloride channels in the GI tract. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. This project is an observational study to examine the effects of lubiprostone on nutritional status and lung function in adults with CF. Our hypothesis is that lubiprostone will have beneficial effects on nutritional status.
Read the detailed description
Background: Cystic fibrosis (CF) affects an estimated 30,000 people in the United States. It is caused by a mutation in the gene encoding a protein called cystic fibrosis transmembrane regulator (CFTR). This protein functions as a chloride channel in epithelial cells of multiple organ systems. The mutation results in a dysfunctional or absent CFTR channel and a decrease in chloride secretion, which results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. This patient population commonly suffers from nutritional deficiency, and achieving and maintaining normal nutritional status is an important goal of therapy as body mass index (BMI) is positively correlated with forced expiratory volume in 1 second (FEV1), a measure of pulmonary function. Lubiprostone activates type 2 chloride channels (ClC-2) on the apical membrane of GI epithelial cells. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. Objectives: The proposed pilot project is a prospective observational study to examine the effects of lubiprostone in adults with CF. The specific aims are to determine the effects of lubiprostone on: 1) nutritional markers and 2) pulmonary function in adults with CF. Methods: Adults with CF who are currently taking lubiprostone chronically will be sought for enrollment. Study subjects will be followed for approximately 3-months with serial assessment of indicators of nutrition and pulmonary function. Nutritional markers to be measured include body weight, albumin, prealbumin, and vitamins A, D, and E. Pulmonary function will be assessed by pulmonary function tests, a survey to monitor for symptoms of pulmonary exacerbation, and monitoring of the frequency of hospitalizations and IV antibiotic use. Expected Results: We expect to see a beneficial effect on nutritional markers, body weight, and BMI. We hope this translates into a concomitant improvement in pulmonary function.
- Conditions
- Cystic Fibrosis, Constipation, Nutrition
- Keywords
- cystic fibrosis, constipation, lubiprostone, nutrition, pulmonary function
- Medical subject headings
- Cystic Fibrosis, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Only group | adult cystic fibrosis patients who are not at goal body mass index and have started lubiprostone therapy within one month of study enrollment |
What is being measured
The primary outcome is the main question the study is designed to answer.
body mass index
Measured: 3 months
Secondary outcomes (4)
pulmonary function tests
Measured: 3 months
cystic fibrosis clinical score
Measured: 3 months
Serum nutritional markers (vitamins A, D, E; albumin; prealbumin)
Measured: 3 months
24-hour diet recall
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: Recruitment was suboptimal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Responsible party
- Sponsor
- Investigators
- Catherine O'Brien, PharmD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577499
- Sponsor's protocol ID
- 84063
- Other IDs
- 07-JI-166
- Status last verified
- Mar 2015
- First submitted
- 18 Dec 2007
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00577499
- Acronym / sponsor ID
- 84063
- Conditions
- Cystic Fibrosis, Constipation, Nutrition
- Keywords
- cystic fibrosis, constipation, lubiprostone, nutrition, pulmonary function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment was suboptimal
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- American Society of Health-System Pharmacists Research and Education Foundation
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cystic fibrosis (CF) results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. Patients commonly suffer from nutritional deficiency, and achieving and maintaining adequate nutrition is an important goal of therapy because it is positively correlated with lung function. Lubiprostone activates chloride channels in the GI tract. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. This project is an observational study to examine the effects of lubiprostone on nutritional status and lung function in adults with CF. Our hypothesis is that lubiprostone will have beneficial effects on nutritional status.
Detailed description
Background: Cystic fibrosis (CF) affects an estimated 30,000 people in the United States. It is caused by a mutation in the gene encoding a protein called cystic fibrosis transmembrane regulator (CFTR). This protein functions as a chloride channel in epithelial cells of multiple organ systems. The mutation results in a dysfunctional or absent CFTR channel and a decrease in chloride secretion, which results in thickened secretions in multiple organ systems including the lungs and gastrointestinal (GI) tract. This patient population commonly suffers from nutritional deficiency, and achieving and maintaining normal nutritional status is an important goal of therapy as body mass index (BMI) is positively correlated with forced expiratory volume in 1 second (FEV1), a measure of pulmonary function. Lubiprostone activates type 2 chloride channels (ClC-2) on the apical membrane of GI epithelial cells. Because its mechanism of action closely parallels the disease pathology, lubiprostone has the potential to provide GI benefits beyond the relief of constipation. Objectives: The proposed pilot project is a prospective observational study to examine the effects of lubiprostone in adults with CF. The specific aims are to determine the effects of lubiprostone on: 1) nutritional markers and 2) pulmonary function in adults with CF. Methods: Adults with CF who are currently taking lubiprostone chronically will be sought for enrollment. Study subjects will be followed for approximately 3-months with serial assessment of indicators of nutrition and pulmonary function. Nutritional markers to be measured include body weight, albumin, prealbumin, and vitamins A, D, and E. Pulmonary function will be assessed by pulmonary function tests, a survey to monitor for symptoms of pulmonary exacerbation, and monitoring of the frequency of hospitalizations and IV antibiotic use. Expected Results: We expect to see a beneficial effect on nutritional markers, body weight, and BMI. We hope this translates into a concomitant improvement in pulmonary function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only group | – | –adult cystic fibrosis patients who are not at goal body mass index and have started lubiprostone therapy within one month of study enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult cystic fibrosis clinic
Key inclusion criteria (5 listed)
- Planning or currently on chronic lubiprostone therapy (chronic is defined as at least one 24 microgram capsule by mouth every other day
- Body mass index (BMI) of less than 22 for females and less than 23 for males at the initiation of chronic lubiprostone therapy
- Initiation of chronic lubiprostone therapy within 1 month of enrollment
- Age over 18
- Currently taking a multivitamin
Key exclusion criteria (5 listed)
- History of noncompliance with medications and other CF therapies
- History of hospital admissions for CF exacerbations of ≥2 in the last 6 months
- FEV1 les than 40% of expected (severe dysfunction) at most recent assessment in the ambulatory setting
- Currently registered on a lung transplant waiting list
- Any other condition, in the opinion of the investigators, that interferes with the ability of the study subject to comply with study requirements, confers significant risk, or limits the ability of the subject to complete the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
body mass index
Time frame: 3 months
4 secondary outcomes
pulmonary function tests
Time frame: 3 months
cystic fibrosis clinical score
Time frame: 3 months
Serum nutritional markers (vitamins A, D, E; albumin; prealbumin)
Time frame: 3 months
24-hour diet recall
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Recruitment was suboptimal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
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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.
Catherine O'Brien, PharmD principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Constipation, run by University of Arkansas.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was suboptimal). Results are not available in the source record.
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?
body mass index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2015.