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

This study has been completed.
Sponsor:
Collaborators:
Seer Pharmaceuticals
CF Therapeutics Development Network Coordinating Center
Cystic Fibrosis Foundation
Information provided by:
Ramsey, Bonnie, MD
ClinicalTrials.gov Identifier:
NCT00219882
First received: September 16, 2005
Last updated: December 18, 2007
Last verified: December 2007

September 16, 2005
December 18, 2007
April 2005
Not Provided
Safety and tolerability of 14 days of treatment with orally administered curcuminoids as assessed by adverse events, laboratory parameters, and spirometry. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • Safety and tolerability of 14 days of treatment with orally administered Curcuminoids as assessed by:
  • - adverse events
  • - abnormal changes in laboratory parameters
  • - changes in spirometry.
Complete list of historical versions of study NCT00219882 on ClinicalTrials.gov Archive Site
(1) Pharmacokinetics of repeated doses of orally administered curcuminoids. (2) Change in nasal potential difference (NPD) measurements. (3) Change in sweat chloride measurements. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • - Pharmocokinetics of repeated doses of orally administered Curcuminoids
  • - Change in nasal potential difference measurements from Screening (Visit 1) to Day 8 (Visit 3), Screening to Day 15 (Visit 4), and Day 8 to Day 15. Specifically:
  • * The change in low chloride plus isoproterenol response
  • * The change in basal PD
  • * The change in amiloride response
  • - Change in sweat chloride measurements from Baseline (at Visit 1, or at Visit 2 prior to dosing, or any day between Visits 1 and 2) to Day 15
Not Provided
Not Provided
 
Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis
A Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator (ΔF508 CFTR) Mutation

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.

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 curcumin for the treatment of cystic fibrosis is the potential for curcumin to help correct a deficiency of the cystic fibrosis transmembrane regulator (CFTR) protein. Cystic fibrosis results from a mutation of the CFTR gene, which produces abnormal CFTR protein that does properly transport chloride ion and water in the lung leading to abnormal mucus production. Curcumin is a potent inhibitor of the endoplasmic reticulum (ER) Ca2+ pump, and lowers ER calcium concentration. This may allow abnormal CFTR protein to function properly as a chloride channel and correct the cystic fibrosis defect. If this is successful, this effect could be measured as a decrease in the nasal potential difference (NPD) and sweat chloride in cystic fibrosis patients.

The primary objective 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. The secondary objectives are to obtain pharmacokinetic data for oral curcumoniods in CF subjects and to assess the effectiveness of curcuminoids to alter nasal potential difference (NPD) and seat chloride concentrations.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
Drug: standardized turmeric root extract
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
Other Name: AFI Curcuminoids
Experimental: 1
standardized turmeric root extract
Intervention: Drug: standardized turmeric root extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
January 2006
Not Provided

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.
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219882
SEER-106
Yes
Chris Goss, MD, University of Washington
Ramsey, Bonnie, MD
  • Seer Pharmaceuticals
  • CF Therapeutics Development Network Coordinating Center
  • Cystic Fibrosis Foundation
Principal Investigator: Chris Goss, MD, MSc University of Washington
Ramsey, Bonnie, MD
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP