Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT00993707
Safety Study of CTX-100 Inhalation Solution (Formerly ETX-100)
A Phase 2 study testing CTX-100 (formerly ETX-100) (hyaluronic acid) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Turino, Gerard, M.D. at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- CTX-100 (formerly ETX-100) (hyaluronic acid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Harbor Medical Center
New York, New York, 10010
St. Luke's-Roosevelt Hospital Center
New York, New York, 10019
Arizona Research Associates
Tucson, Arizona, 85712
About this study
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
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.
- Being tested
- CTX-100 (formerly ETX-100) (hyaluronic acid)
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-100 (formerly ETX-100) (hyaluronic acid)Drug
Also called CTX-100, 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.
| Study group | Role | What they receive |
|---|---|---|
| 0.01% CTX-100 (formerly ETX-100) | Active comparator | Not described Receives: Drug: CTX-100 (formerly ETX-100) (hyaluronic acid) |
| 0.03% CTX-100 (formerly ETX-100) | Active comparator | Not described Receives: Drug: CTX-100 (formerly ETX-100) (hyaluronic acid) |
| Placebo | Placebo comparator | Not described Receives: Drug: CTX-100 (formerly ETX-100) (hyaluronic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startNov 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turino, Gerard, M.D.
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gerard Turino, M.D., Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993707
- Sponsor's protocol ID
- C100-005
- Other IDs
- 1R01HL081489-01A1
- Status last verified
- Dec 2019
- First submitted
- 22 Sep 2009
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00993707
- Acronym / sponsor ID
- C100-005
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Turino, Gerard, M.D.
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTX-100 (formerly ETX-100) (hyaluronic acid)Also: CTX-100, ETX-100, Hyaluronic acid3 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. | Drug | 0.01% CTX-100 (formerly ETX-100), 0.03% CTX-100 (formerly ETX-100), Placebo |
Primary outcome
Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events
Time frame: 1 month
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Turino, M.D. principal investigator
St. Luke's-Roosevelt Hospital Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTX-100 (formerly ETX-100) (hyaluronic acid) in people with Chronic Obstructive Pulmonary Disease (COPD), run by Turino, Gerard, M.D. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.