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

NCT00993707 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-12-05

No results posted yet for this 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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Turino, Gerard, M.D.

    lead INDIV

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00993707 on ClinicalTrials.gov