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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993707
• Other study ID #: C100-005
• Secondary ID: 1R01HL081489-01A
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: December 2019
• Source: Turino, Gerard, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	St. Luke's-Roosevelt Hospital Center	New York	New York
United States	VA Harbor Medical Center	New York	New York
United States	Arizona Research Associates	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Turino, Gerard, M.D.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events		1 month
Secondary	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