Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis

This study has been terminated.
(Recruitment was suboptimal)
Sponsor:
Collaborator:
American Society of Health-System Pharmacists Research and Education Foundation
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00577499
First received: December 18, 2007
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

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.


Condition
Cystic Fibrosis
Constipation
Nutrition

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • body mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pulmonary function tests [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • cystic fibrosis clinical score [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Serum nutritional markers (vitamins A, D, E; albumin; prealbumin) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 24-hour diet recall [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: October 2007
Estimated Study Completion Date: May 2009
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult cystic fibrosis clinic

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577499

Sponsors and Collaborators
University of Arkansas
American Society of Health-System Pharmacists Research and Education Foundation
Investigators
Principal Investigator: Catherine O'Brien, PharmD University of Arkansas
  More Information

No publications provided

Responsible Party: Catherine E. O'Brien, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00577499     History of Changes
Other Study ID Numbers: 84063, 07-JI-166
Study First Received: December 18, 2007
Last Updated: March 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
cystic fibrosis
constipation
lubiprostone
nutrition
pulmonary function

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Constipation
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014