Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Arkansas
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Number of Spontaneous Bowel Movements Per Week
Study Overview
Brief Summary
The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.
Detailed Description
Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women of all races
- •18 years of age or older at time of enrollment
- •Diagnosis of cystic fibrosis
- •History of constipation, as defined by the Rome III criteria, OR the requirement of chronic scheduled doses of a laxative, OR a score ≥1.5 on the Patient assessment of constipation symptoms (PAC-SYM)15 survey administered during the screening visit, OR a score of less than 3 on the Bristol Stool Scale (BSS) at the screening visit.
Exclusion Criteria
- •Current gastrointestinal (GI) obstruction
- •History of GI obstruction requiring hospitalization within six months of enrollment
- •Pregnancy or breastfeeding
- •Hypersensitivity to lubiprostone or any of its components
- •Serum creatinine >1.8 mg/dL at last annual visit
- •Clinically significant liver disease, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3X upper limit of normal
- •History of frequent hospital admissions for CF exacerbations (≥4 in the last 6 months)
- •Currently registered on a lung transplant waiting list
- •Women of capable of child-bearing who either refuse a pregnancy test, or are incapable or unwilling to use contraception during the protocol, or both.
- •Any other condition, in the opinion of the investigators, that interferes with the ability of the participant to comply with study requirements, confers significant risk to the participant, or limits the ability of the participant to complete the study
Outcomes
Primary Outcomes
Number of Spontaneous Bowel Movements Per Week
Time Frame: 2-week run-in period, 2-weeks of treatment, 4-weeks of treatment
Secondary Outcomes
- Serum Prealbumin(baseline and 4 weeks)
- Serum Albumin(baseline and 4 weeks)
- Patient Assessment of Constipation Symptoms(2-week run-in period, 2 weeks of treatment, 4 weeks of treatment)
- Bristol Stool Scale Score(2-week run-in period, 2 weeks of treatment, 4 weeks of treatment)
- Body Mass Index(baseline, 2 weeks of treatment, 4 weeks of treatment)
- Self Reported Adverse Effects at Each Study Visit(During entire study period)
- Serum Sodium(baseline, 4 weeks)
- Serum Chloride(baseline and 4 weeks)
- Serum Potassium(baseline and 4 weeks)
- Serum Bicarb(baseline and 4 weeks)
- Serum BUN(baseline and 4 weeks)
- Serum Creatinine(baseline and 4 weeks)
- AST(baseline and 4 weeks)
- ALT(baseline and 4 weeks)
- Serum Calcium(baseline and 4 weeks)
- Serum Magnesium(baseline and 4 weeks)
- Serum Phosphate(baseline and 4 weeks)
- Serum Glucose(baseline and 4 weeks)
- Serum Vitamin D(baseline and 4 weeks)
- Serum Vitamin A(baseline and 4 weeks)
- Serum Vitamin E(baseline and 4 weeks)