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

NCT00577499 | Terminated

• 2 other identifiers: 8406307-JI-166
• Study Type: observational
• Target: 7
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis; Constipation; Nutrition

Keywords

cystic fibrosis; constipation; lubiprostone; nutrition; pulmonary function

Outcome Measures

Primary Outcomes (1)

• body mass index

  3 months

Secondary Outcomes (4)

• pulmonary function tests

  3 months

• cystic fibrosis clinical score

  3 months

• Serum nutritional markers (vitamins A, D, E; albumin; prealbumin)

  3 months

• 24-hour diet recall

  3 months

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adult cystic fibrosis clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arkansas: lead
• American Society of Health-System Pharmacists Research and Education Foundation: collaborator

MeSH Terms

Conditions

Cystic Fibrosis; Constipation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine O'Brien, PharmD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 20, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: March 4, 2015

Record last verified: 2015-03