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
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: standardized turmeric root extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ramsey, Bonnie, MD:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • (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 ]

Enrollment: 11
Study Start Date: April 2005
Study Completion Date: January 2006
Arms Assigned Interventions
Experimental: 1
standardized turmeric root extract
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219882

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Washington
University of Washington
Seattle, Washington, United States, 98195-6522
Sponsors and Collaborators
Ramsey, Bonnie, MD
Seer Pharmaceuticals
CF Therapeutics Development Network Coordinating Center
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Chris Goss, MD, MSc University of Washington
  More Information

No publications provided

Responsible Party: Chris Goss, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00219882     History of Changes
Other Study ID Numbers: SEER-106
Study First Received: September 16, 2005
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Ramsey, Bonnie, MD:
Cystic Fibrosis
curcuminoids
turmeric root extract
nasal potential difference (NPD)
sweat chloride

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014