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CompletedNCT00993707Updated Dec 5, 2019

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

A Phase 2 interventional study of CTX-100 (formerly ETX-100) (hyaluronic acid) in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Turino, Gerard, M.D.. Completed at 3 sites in United States. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by Turino, Gerard, M.D. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)

Keywords

  • Chronic Obstructive Pulmonary Disease (COPD)
03

In context

Pulmonary Disease, Chronic Obstructive

4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's enrollment of 11 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

This is the only study on the registry with Turino, Gerard, M.D. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    0.01% CTX-100 (formerly ETX-100)

    Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)

  • Active comparator
    0.03% CTX-100 (formerly ETX-100)

    Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)

  • Placebo comparator
    Placebo

    Drug: CTX-100 (formerly ETX-100) (hyaluronic acid)

Interventions

  • DrugCTX-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.

    Also known as: CTX-100, ETX-100, Hyaluronic acid

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

3 sites
  • Arizona Research Associates
    Tucson, Arizona 85712, United States
  • VA Harbor Medical Center
    New York, New York 10010, United States
  • St. Luke's-Roosevelt Hospital Center
    New York, New York 10019, United States
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00993707
Lead sponsor
Turino, Gerard, M.D.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Oct 12, 2009
Start date
Nov 2010
Primary completion
Mar 2013
Completion
Mar 2013
Last update
Dec 5, 2019

Study contacts

Gerard Turino, M.D.
principal investigator · St. Luke's-Roosevelt Hospital Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Hyaluronic Acid

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