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

NCT00993707 | Completed Phase 2 DMC

• 2 other identifiers: C100-0051R01HL081489-01A1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 month

Study Arms (3)

0.01% CTX-100 (formerly ETX-100)

ACTIVE COMPARATOR

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

0.03% CTX-100 (formerly ETX-100)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

CTX-100 (formerly ETX-100) (hyaluronic acid) DRUG

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

0.01% CTX-100 (formerly ETX-100); 0.03% CTX-100 (formerly ETX-100); Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Turino, Gerard, M.D.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Arizona Research Associates

Tucson, Arizona, 85712, United States

Location

VA Harbor Medical Center

New York, New York, 10010, United States

Location

St. Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Gerard Turino, M.D.

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: October 12, 2009
• Study Start: November 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (3)