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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CTX-100 (formerly ETX-100) (hyaluronic acid)
Sponsored by
Turino, Gerard, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Arizona Research Associates
  • VA Harbor Medical Center
  • St. Luke's-Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

0.01% CTX-100 (formerly ETX-100)

0.03% CTX-100 (formerly ETX-100)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events

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.

Full Information

First Posted
September 22, 2009
Last Updated
December 3, 2019
Sponsor
Turino, Gerard, M.D.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00993707
Brief Title
Safety Study of CTX-100 Inhalation Solution (Formerly ETX-100)
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 Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turino, Gerard, M.D.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.01% CTX-100 (formerly ETX-100)
Arm Type
Active Comparator
Arm Title
0.03% CTX-100 (formerly ETX-100)
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CTX-100 (formerly ETX-100) (hyaluronic acid)
Other Intervention Name(s)
CTX-100, ETX-100, Hyaluronic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Turino, M.D.
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Research Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
VA Harbor Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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