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

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ClinicalTrials.gov Identifier: NCT00993707
Recruitment Status : Unknown
Verified June 2011 by Turino, Gerard, M.D..
Recruitment status was:  Recruiting
First Posted : October 12, 2009
Last Update Posted : June 20, 2011
Sponsor:
Information provided by:
Turino, Gerard, M.D.

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: CTX-100 (formerly ETX-100) (hyaluronic acid) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : November 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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.         
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.         
Sponsors and Collaborators
Turino, Gerard, M.D.
Investigators
Principal Investigator: Gerard Turino, M.D. St. Luke's-Roosevelt Hospital Center

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 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011

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
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents