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Safety Study of CTX-100 Inhalation Solution (Formerly ETX-100)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Turino, Gerard, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Turino, Gerard, M.D.
ClinicalTrials.gov Identifier:
NCT00993707
First received: September 22, 2009
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

The purpose of the study is to evaluate the safety of administering repeated doses of CTX-100 (formerly ETX-100) to subjects with smoking-related chronic obstructive pulmonary disease.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2a, Ascending Dose, Placebo-Controlled Study to Evaluate the Safety of CTX-100 (Formerly ETX-100) Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Turino, Gerard, M.D.:

Primary Outcome Measures:
  • Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of elastin breakdown as measured by levels of elastin crosslinking amino acids desmosine/isodesmosine (D/I) in induced sputum, plasma, and urine. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: November 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.01% CTX-100 (formerly ETX-100) Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)

3 mL of either 0.01%, 0.03% CTX-100 (formerly ETX-100), or placebo will be dispensed into the PARI LC STAR nebulizer and inhaled using the PARI Ultra II compressors.

Number of cycles: if the study drug (0.01% CTX-100 Inhalation Solution or placebo) bid is well tolerated in the first cohort, the second cohort of subjects will begin dosing with 0.03% CTX-100 Inhalation Solution or placebo in the same manner as the first cohort.

Other Names:
  • CTX-100
  • ETX-100
  • Hyaluronic acid
Active Comparator: 0.03% CTX-100 (formerly ETX-100) Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)

3 mL of either 0.01%, 0.03% CTX-100 (formerly ETX-100), or placebo will be dispensed into the PARI LC STAR nebulizer and inhaled using the PARI Ultra II compressors.

Number of cycles: if the study drug (0.01% CTX-100 Inhalation Solution or placebo) bid is well tolerated in the first cohort, the second cohort of subjects will begin dosing with 0.03% CTX-100 Inhalation Solution or placebo in the same manner as the first cohort.

Other Names:
  • CTX-100
  • ETX-100
  • Hyaluronic acid
Placebo Comparator: Placebo Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)

3 mL of either 0.01%, 0.03% CTX-100 (formerly ETX-100), or placebo will be dispensed into the PARI LC STAR nebulizer and inhaled using the PARI Ultra II compressors.

Number of cycles: if the study drug (0.01% CTX-100 Inhalation Solution or placebo) bid is well tolerated in the first cohort, the second cohort of subjects will begin dosing with 0.03% CTX-100 Inhalation Solution or placebo in the same manner as the first cohort.

Other Names:
  • CTX-100
  • ETX-100
  • Hyaluronic acid

Detailed Description:

The study primarily aims to establish safety and evaluate biochemical activity of CTX-100 (formerly ETX-100) with respect to elastin breakdown, but will also concurrently gather data that may point to efficacy. The preliminary efficacy results will be used to assist in the design of subsequent phase 2b clinical studies of longer duration to examine both efficacy and safety of CTX-100 as a therapy for chronic obstructive pulmonary disease.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to provide written informed consent and comply with study requirements.
  • Men or women aged 40 through 75 years at the time of consent.
  • At least 10-pack years (average packs/day x number of years) of cigarette use, and either current smoker or ex-smoker.
  • Diagnosis of COPD at screening consistent with National Institutes of Health guidelines.
  • Evidence of emphysema on chest x-ray.
  • A ratio of prebronchodilator FEV1 to forced vital capacity (FVC) of ≤ 70% at screening.
  • FEV1 ≥ 50% (prebronchodilator) and ≤ 79% (postbronchodilator) of predicted normal at screening.
  • Clinical laboratory tests (complete blood count, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the PI/sponsor at screening.
  • Women of childbearing potential and men who are sexually active must agree to use an adequate method of contraception (oral contraceptives, depot progesterone, condom plus spermicide, or IUD) during the study and for 1 month after the final dose of study drug.

Exclusion Criteria:

  • Subjects with a measured DLCO of ≤ 50%, or unable to perform a reproducible DLCO.
  • Subjects unable to perform 3 reproducible spirometry tests after 5 attempts.
  • Upper or lower respiratory tract infection within 2 weeks prior to screening and baseline (day 1).
  • Presence of clinically relevant abnormality on chest x-ray (other than evidence of emphysema) at screening or within the previous 12 months.
  • Use of supplemental oxygen therapy.
  • Requirement for ventilatory support within the last year.
  • Exacerbation requiring treatment with systemic corticosteroids within the last 3 months.
  • History of lung transplant.
  • Presence of clinically relevant abnormality on electrocardiogram (ECG).
  • Any medical condition that, in the investigator's judgment, would compromise study participation or the evaluation of the study drug.
  • Women who are pregnant or breastfeeding.
  • Receipt of an investigational drug within 30 days prior to screening (including subjects who participated in the first phase of this study).
  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: NCT00993707

Contacts
Contact: Gerard Turino, M.D. 212-523-5919 gmt1@columbia.edu

Locations
United States, Arizona
Arizona Research Associates Recruiting
Tucson, Arizona, United States, 85712
Contact: Carl Diener, M.D.    520-795-7724      
Principal Investigator: Carl Diener, M.D.         
United States, New York
St. Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10019
Contact: Gerard Turino, M.D.    212-523-5919    gmt1@columbia.edu   
Principal Investigator: Gerard Turino, M.D.         
VA Harbor Medical Center Recruiting
New York, New York, United States, 10010
Contact: Kevin Felner, M.D.    917-532-3537    Kevin.Felner@med.va.gov   
Principal Investigator: Kevin Felner, M.D.         
Sponsors and Collaborators
Turino, Gerard, M.D.
Investigators
Principal Investigator: Gerard Turino, M.D. St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: Gerard Turino, M.D., Director, James P Mara Center for Lung Disease, St. Luke's Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00993707     History of Changes
Other Study ID Numbers: C100-005, 1R01HL081489-01A1
Study First Received: September 22, 2009
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Turino, Gerard, M.D.:
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Hyaluronic Acid
Pharmaceutical Solutions
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Viscosupplements

ClinicalTrials.gov processed this record on November 25, 2014