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

NCT ID: NCT00993707

Last Updated: 2019-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-03-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.01% CTX-100 (formerly ETX-100)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

0.03% CTX-100 (formerly ETX-100)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Placebo

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

CTX-100; ETX-100; Hyaluronic acid

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Turino, Gerard, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Turino, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Luke's-Roosevelt Hospital Center

Locations

Arizona Research Associates

Tucson, Arizona, United States

VA Harbor Medical Center

New York, New York, United States

St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Countries

United States

Other Identifiers

1R01HL081489-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

C100-005

Identifier Type: -

Identifier Source: org_study_id