Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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 for ΔF508 CFTR.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ramsey, Bonnie, MD
• Collaborators: CF Therapeutics Development Network Coordinating Center; Cystic Fibrosis Foundation; Cystic Fibrosis Foundation Therapeutics; Seer Pharmaceuticals
• Treatments: Turmeric extract

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.