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

NCT ID: NCT00219882

Last Updated: 2007-12-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-01-31

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.

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.

Conditions

Cystic Fibrosis

Keywords

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

standardized turmeric root extract

Group Type: EXPERIMENTAL

standardized turmeric root extract

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

AFI Curcuminoids

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seer Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

CF Therapeutics Development Network Coordinating Center

NETWORK

Sponsor Role: collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Ramsey, Bonnie, MD

INDIV

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Chris Goss, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

SEER-106

Identifier Type: -

Identifier Source: org_study_id