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

• ClinicalTrials.gov Identifier: NCT00577499
• Recruitment Status: Terminated
• First Posted: December 20, 2007
• Last Update Posted: March 4, 2015
• Sponsor: University of Arkansas
• Collaborator: American Society of Health-System Pharmacists Research and Education Foundation
• Information provided by (Responsible Party): University of Arkansas

Study Description

Brief 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 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 or disease
Cystic Fibrosis; Constipation; Nutrition

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

• Study Type: Observational
• Actual Enrollment: 7 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis
• Study Start Date: October 2007
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: June 2009

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Primary Outcome Measures :

1. body mass index [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. pulmonary function tests [ Time Frame: 3 months ]
2. cystic fibrosis clinical score [ Time Frame: 3 months ]
3. Serum nutritional markers (vitamins A, D, E; albumin; prealbumin) [ Time Frame: 3 months ]
4. 24-hour diet recall [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT00577499
• Other Study ID Numbers: 84063; 07-JI-166
• First Posted: December 20, 2007
• Last Update Posted: March 4, 2015
• Last Verified: March 2015

Keywords provided by University of Arkansas:

cystic fibrosis; constipation; lubiprostone; nutrition; pulmonary function

Additional relevant MeSH terms:

Cystic Fibrosis; Fibrosis; Constipation; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Signs and Symptoms, Digestive