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

NCT00219882 | Completed Phase 1 DMC

• 1 other identifier: SEER-106
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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 for ΔF508 CFTR.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; curcuminoids; turmeric root extract; nasal potential difference (NPD); sweat chloride

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of 14 days of treatment with orally administered curcuminoids as assessed by adverse events, laboratory parameters, and spirometry.

  14 days

Secondary Outcomes (1)

• (1) Pharmacokinetics of repeated doses of orally administered curcuminoids. (2) Change in nasal potential difference (NPD) measurements. (3) Change in sweat chloride measurements.

  14 days

Study Arms (1)

1

EXPERIMENTAL

standardized turmeric root extract

Drug: standardized turmeric root extract

Interventions

standardized turmeric root extract DRUG

1.5 gm of standardized tumeric root extract three times per day for seven consecutive days, followed by 3 gm of standardized tumeric root extract three times per day for seven consecutive days

Also known as: AFI Curcuminoids

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsey, Bonnie, MD: lead
• Seer Pharmaceuticals: collaborator
• CF Therapeutics Development Network Coordinating Center: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Washington

Seattle, Washington, 98195-6522, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

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

Study Officials

• Chris Goss, MD, MSc

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2005
• Study Completion: January 1, 2006
• Last Updated: December 25, 2007

Record last verified: 2007-12

Locations

US (2)