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

December 18, 2007
March 14, 2011
October 2007
Not Provided
body mass index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00577499 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis
Effect of Lubiprostone on Nutritional Status and Pulmonary Function in Adults With Cystic Fibrosis

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

adult cystic fibrosis clinic

  • Cystic Fibrosis
  • Constipation
  • Nutrition
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
May 2009
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00577499
84063, 07-JI-166
No
Catherine E. O'Brien, University of Arkansas for Medical Sciences
University of Arkansas
American Society of Health-System Pharmacists Research and Education Foundation
Principal Investigator: Catherine O'Brien, PharmD University of Arkansas
University of Arkansas
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP