Status:
COMPLETED
Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis
Lead Sponsor:
Ramsey, Bonnie, MD
Collaborating Sponsors:
Seer Pharmaceuticals
CF Therapeutics Development Network Coordinating Center
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety of advancing doses of curcuminoids administered orally for fourteen consecutive days in adult subjects with cystic fibrosis (CF) who are homozygous fo...
Detailed Description
The drug substance being studied is curcumin. Curcumin (diferuloylmethane) is a major constituent in the spice turmeric, which is used as a food worldwide. The pharmacologic rationale for studying cu...
Eligibility Criteria
Inclusion
- Male or female 18 - 40 years of age.
- Documented history of being homozygous for ΔF508 CFTR genotype.
- Able to perform spirometry maneuvers, and have a forced expiratory volume at 1 second (FEV1) greater than or equal to 30% of predicted normal for age, gender, and height (Knudson standards) at screening.
- Oxygen saturation (as measured by pulse oximetry) \> 90% on room air at screening.
- Clinically stable with no evidence of acute upper or lower respiratory tract infection.
- Non-smoker for at least 6 months prior to screening.
- Able to understand and sign a written informed consent and comply with the requirements of the study.
Exclusion
- Diagnosis of acute pulmonary exacerbation (PE) requiring antibiotic intervention within 4 weeks prior to screening.
- Patient reported history of viral upper respiratory tract infection within 2 weeks prior to screening.
- History of major complications of lung disease (including recent massive hemoptysis or pneumothorax) within two months prior to screening Visit.
- Acute nosebleeds within 14 days prior to screening.
- Nasal surgery within 4 weeks prior to screening.
- Begun use of nasal antibiotics, nasal steroids, nasal cromolyn, nasal atrovent, nasal phenylephrine, or oxymetazoline within 14 days prior to screening.
- Chest x-ray at screening or within 3 months of screening with abnormalities suggesting clinically significant active pulmonary disease other than cystic fibrosis, and/or new CF-specific changes including atelectasis, small pneumothoraces, or pneumonia.
- EKG at screening which shows clinically significant abnormality including prolonged QTc, bundle branch block, rhythm other than sinus, evidence of ischemic heart disease.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00219882
Start Date
April 1 2005
End Date
January 1 2006
Last Update
December 25 2007
Active Locations (2)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
University of Washington
Seattle, Washington, United States, 98195-6522