Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT04600778
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Cavosonstat Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Cavosonstat 5 mg, Cavosonstat 10 mg and Cavosonstat 25 mg in people with Chronic Obstructive Pulmonary Disease (COPD), run by GSNOR Therapeutics, Inc..
Trial summary
Brief Summary: The purpose of this study is to to evaluate the efficacy and safety of Cavosonstat administered twice daily compared with Placebo for 24 Weeks in adult subjects with Chronic Obstructive Pulmonary Disease (COPD) Detailed Description:To investigate the effect of cavosonstat compared with placebo, on the… 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?
- Cavosonstat 5 mg, Cavosonstat 10 mg and Cavosonstat 25 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2021to 30 Apr 2022
- 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
- Patients with moderate to severe COPD, who meet the following criteria (full details in main text):
- Male or female aged between 40 and 75 years inclusive, at the time of informed consent
- Patients with symptomatic COPD as defined by the 2019 GOLD diagnostic criteria
- Post-bronchodilator (four puffs of albuterol) spirometry at screening demonstrating the following:
- FEV1/forced vital capacity (FVC) ratio of <0.70
- FEV1 ≥30% and FEV1 <80% of predicted normal
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- Current or prior history of ≥10 pack-years of cigarette smoking
- Participants with COPD Assessment Test (CAT) score ≥10 at screening
- Participants with a documented history of ≥1 moderate exacerbation within the year prior to screening
- Participants with standard of care background therapy for three months and at a stable dose for at least one month, including either:
- Single therapy: long-acting muscarinic agonist (LAMA), or
- Double therapy: long-acting beta agonist (LABA) plus long-acting muscarinic agonist (LAMA) or inhaled corticosteroid (ICS) plus LABA or ICS plus LAMA, or
- Triple therapy: LABA plus LAMA plus ICS
- Meet the concomitant medication restrictions and continue to do so throughout the study
- Have body mass index >21 kg/m2 and < 35 kg/m2
- Males must agree not to donate sperm. They must be sexually abstinent or use a condom with all sexual partners. If the partner is of child-bearing potential, a condom with spermicide and a second reliable form of contraception must also be used
- Females must be of non-childbearing potential, be sexually abstinent or use a highly effective form of contraception.
- Able to sign an informed consent document
Who cannot join
- Patients meeting any of the following criteria must be excluded from the study (full details in main text):
- Patients with other respiratory disorders: current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, uncontrolled or unstable sleep apnea, cor pulmonale, clinically significant pulmonary hypertension or other active pulmonary diseases
- Chest X-ray (or computerized tomography [CT] scan) reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD
- Moderate or severe AECOPD within the previous four weeks
- An upper or lower respiratory tract infection that required the use of antibiotics within the previous four weeks
- Long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for more than 12 hours a day
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- Oral therapies for COPD (e.g. oral steroids, theophylline and roflumilast) or antibiotics or oral corticosteroid therapy within four weeks prior to screening
- Prior history of, or planned pneumonectomy or lung volume reduction surgery
- Participation in the acute phase of a pulmonary rehabilitation program within four weeks of screening or planned during the study
- History of malignancy of any organ system within five years, except skin cancer which has been stable over one year and the investigator believes is no clinical significance.
- Patients with uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant. This includes any hepatic disease or moderate to severe renal impairment.
- Documented clinically significant cardiovascular disease such as: any history of arrhythmias, angina, recent (<1 year) or suspected myocardial infarction, congestive heart failure, unstable or uncontrolled hypertension, or diagnosis of hypertension within 3 months prior to Screening.
- Known or suspected history of alcohol or drug abuse within the last 5 years. Positive urine drug screen and blood alcohol level screen.
- Clinically significant abnormal values for laboratory safety tests (hematology, blood chemistry, viral serology or urinalysis) at Screening, as determined by the Investigator.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than twice the upper limit of normal.
- Received an experimental drug within 30 days or five half-lives, whichever is longer.
- Women who are pregnant or breast-feeding.
- Prior exposure to a GSNOR inhibitor.
- Major surgery (requiring general anesthesia) within 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
- A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
- Any other reason that the Investigator considers makes the patient unsuitable to participate.
About this study
Brief Summary: The purpose of this study is to to evaluate the efficacy and safety of Cavosonstat administered twice daily compared with Placebo for 24 Weeks in adult subjects with Chronic Obstructive Pulmonary Disease (COPD)
Detailed Description:To investigate the effect of cavosonstat compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over 24 weeks of treatment.
Read more
To investigate:
- The effect of cavosonstat compared with placebo, on the duration from baseline to first moderate AECOPD event
- The effect of cavosonstat compared with placebo, on respiratory function, as assessed by post-bronchodilator percent-predicted forced expiratory volume in one second (ppFEV1)
- The effect of cavosonstat compared with placebo on annualized rate of moderate AECOPD over 24 weeks of treatment
- The effect of cavosonstat compared with placebo on annualized rate of severe AECOPD over 24 weeks of treatment
- The safety and tolerability of cavosonstat compared with placebo
- The pharmacokinetics of cavosonstat
- Assessment of quality of life
- Being tested
- placebo, Cavosonstat 5 mg, Cavosonstat 10 mg, Cavosonstat 25 mg
- 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.
placeboOther
placebo
Cavosonstat 5 mgDrug
Cavosonstat (low dose)
Cavosonstat 10 mgDrug
Cavosonstat (medium dose)
Cavosonstat 25 mgDrug
Cavosonstat (high dose)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | twice daily Receives: Other: placebo |
| Cavosonstat 5 mg | Experimental | twice daily Receives: Drug: Cavosonstat 5 mg |
| Cavosonstat 10 mg | Experimental | twice daily Receives: Drug: Cavosonstat 10 mg |
| Cavosonstat 25 mg | Experimental | twice daily Receives: Drug: Cavosonstat 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of moderate-to-severe acute exacerbations of COPD
To investigate the effect of cavosonstat compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over 24 weeks of treatment.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start3 Feb 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GSNOR Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600778
- Sponsor's protocol ID
- LVC-N91115-PS-II-01
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Cavosonstat Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04600778
- Acronym / sponsor ID
- LVC-N91115-PS-II-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- GSNOR Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 23 Oct 2020 (actual)
- 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.
Brief Summary: The purpose of this study is to to evaluate the efficacy and safety of Cavosonstat administered twice daily compared with Placebo for 24 Weeks in adult subjects with Chronic Obstructive Pulmonary Disease (COPD)
Detailed Description:To investigate the effect of cavosonstat compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over 24 weeks of treatment.
To investigate:
- The effect of cavosonstat compared with placebo, on the duration from baseline to first moderate AECOPD event
- The effect of cavosonstat compared with placebo, on respiratory function, as assessed by post-bronchodilator percent-predicted forced expiratory volume in one second (ppFEV1)
- The effect of cavosonstat compared with placebo on annualized rate of moderate AECOPD over 24 weeks of treatment
- The effect of cavosonstat compared with placebo on annualized rate of severe AECOPD over 24 weeks of treatment
- The safety and tolerability of cavosonstat compared with placebo
- The pharmacokinetics of cavosonstat
- Assessment of quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: placebotwice daily |
| Cavosonstat 5 mg | Experimental | Drug: Cavosonstat 5 mgtwice daily |
| Cavosonstat 10 mg | Experimental | Drug: Cavosonstat 10 mgtwice daily |
| Cavosonstat 25 mg | Experimental | Drug: Cavosonstat 25 mgtwice daily |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients with moderate to severe COPD, who meet the following criteria (full details in main text):
Key exclusion criteria (21 listed)
- Patients meeting any of the following criteria must be excluded from the study (full details in main text):
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 |
|---|---|---|
| placeboplacebo | Other | placebo |
| Cavosonstat 5 mgCavosonstat (low dose) | Drug | Cavosonstat 5 mg |
| Cavosonstat 10 mgCavosonstat (medium dose) | Drug | Cavosonstat 10 mg |
| Cavosonstat 25 mgCavosonstat (high dose) | Drug | Cavosonstat 25 mg |
Primary outcome
Annualized rate of moderate-to-severe acute exacerbations of COPD
Time frame: 24 weeks
To investigate the effect of cavosonstat compared with placebo, on the annualized rate of moderate-to-severe acute exacerbations of COPD (AECOPD) over 24 weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cavosonstat 5 mg, Cavosonstat 10 mg and Cavosonstat 25 mg in people with Chronic Obstructive Pulmonary Disease (COPD), run by GSNOR Therapeutics, Inc..
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 18 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Annualized rate of moderate-to-severe acute exacerbations of COPD (time frame: 24 weeks). 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 23 Oct 2020.