Pulmonary Disease, Chronic ObstructivePhase 4NCT02579772
Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction
A Phase 4 study testing N-acetylcysteine in people with Pulmonary Disease, Chronic Obstructive, run by Queen's University.
Trial summary
The main purpose of this study is to determine whether pharmacological treatment with N-acetylcysteine improves central and peripheral cardiorespiratory control and physical capacity in COPD patients with mild-to-moderate airflow obstruction. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to May 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable COPD with mild-to-moderate airflow obstruction as indicated by the low ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC<0.7) together with post-bronchodilator FEV1≥60% predicted under optimized clinical treatment as judged by the accompanying physician
Who cannot join
- unable to perform all experimental procedures and/or provide informed consent;
- hospital admission in the previous 6 weeks;
- exercise training program in the previous 6 months;
- any condition that could interfere with the ability to exercise;
- diagnosed psychiatric or cognitive disorders;
- type I insulin-dependent diabetes mellitus;
- excessively over-weight (BMI>35kg/m²);
- other diagnosed cardiorespiratory disorders (e.g., chronic heart failure, peripheral artery disease).
About this study
Official title: Systemic Vascular Dysfunction in COPD Patients With Mild-to-moderate Airflow Obstruction: Pharmacological Treatment With N-acetylcysteine
The main purpose of this study is to determine whether pharmacological treatment with N-acetylcysteine improves central and peripheral cardiorespiratory control and physical capacity in COPD patients with mild-to-moderate airflow obstruction.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Cardiovascular complications constitute the main causes of poor physical capacity and healthcare resources utilization in COPD. There is emerging evidence that these impairments have a major impact on the health of patients with mild-to-moderate disease, the largest sub-population of COPD. This important problem, however, is currently neglected as no specific pharmacological treatment is offered to these patients. Recent studies indicate that vascular abnormalities are mediated, at least in part, by circulating inflammatory substances and direct damage of the arteries by oxygen radicals (oxidative stress). The current investigation will test the hypothesis that N-acetylcysteine (NAC), via its anti-inflammatory and antioxidant properties, improves systemic vascular function and physical capacity in COPD patients with mild-to-moderate airflow obstruction.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- N-acetylcysteine, Placebo
- 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.
N-acetylcysteineDrug
Also called NAC pills
Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment.
PlaceboDrug
Also called Placebo pills
Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
| Study group | Role | What they receive |
|---|---|---|
| N-acetylcysteine | Active comparator | Pharmacological treatment with N-acetylcysteine (NAC) pills Receives: Drug: N-acetylcysteine |
| Placebo | Placebo comparator | Treatment with placebo pills Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Redox Status - Circulating Glutathione
Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Measured: pre-exercise value (day 4)
Exercise Capacity - Time to Exhaustion
Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Measured: end-exercise value (Day 4)
Secondary outcomes (5)
Change in Central Cardiovascular Function - Cardiac Output
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Measured: end-exercise value (Day 4)
Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Measured: Day 4
Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Measured: Day 4
Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)
Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Measured: Day 4
Change in Pulmonary Ventilation - Minute Ventilation (VE)
During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Measured: end-exercise value (Day 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. J. Alberto Neder, Queen's University
- Investigators
- J. Alberto Neder, MD, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579772
- Sponsor's protocol ID
- 6015083
- Status last verified
- May 2018
- First submitted
- 15 Oct 2015
- Last updated
- 14 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Vascular Dysfunction in COPD Patients With Mild-to-moderate Airflow Obstruction: Pharmacological Treatment With N-acetylcysteine
- ClinicalTrials.gov ID
- NCT02579772
- Acronym / sponsor ID
- 6015083
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Posted 14 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to determine whether pharmacological treatment with N-acetylcysteine improves central and peripheral cardiorespiratory control and physical capacity in COPD patients with mild-to-moderate airflow obstruction.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Cardiovascular complications constitute the main causes of poor physical capacity and healthcare resources utilization in COPD. There is emerging evidence that these impairments have a major impact on the health of patients with mild-to-moderate disease, the largest sub-population of COPD. This important problem, however, is currently neglected as no specific pharmacological treatment is offered to these patients. Recent studies indicate that vascular abnormalities are mediated, at least in part, by circulating inflammatory substances and direct damage of the arteries by oxygen radicals (oxidative stress). The current investigation will test the hypothesis that N-acetylcysteine (NAC), via its anti-inflammatory and antioxidant properties, improves systemic vascular function and physical capacity in COPD patients with mild-to-moderate airflow obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-acetylcysteine | Active comparator | Drug: N-acetylcysteinePharmacological treatment with N-acetylcysteine (NAC) pills |
| Placebo | Placebo comparator | Drug: PlaceboTreatment with placebo pills |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable COPD with mild-to-moderate airflow obstruction as indicated by the low ratio between forced expiratory volume in one second and forced vital capacity (FEV1/FVC<0.7) together with post-bronchodilator FEV1≥60% predicted under optimized clinical treatment as judged by the accompanying physician
Key exclusion criteria (8 listed)
- unable to perform all experimental procedures and/or provide informed consent;
- hospital admission in the previous 6 weeks;
- exercise training program in the previous 6 months;
- any condition that could interfere with the ability to exercise;
- diagnosed psychiatric or cognitive disorders;
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 |
|---|---|---|
| N-acetylcysteineAlso: NAC pillsPharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment. | Drug | N-acetylcysteine |
| PlaceboAlso: Placebo pillsPlacebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment. | Drug | Placebo |
Primary outcome
Plasma Redox Status - Circulating Glutathione
Time frame: pre-exercise value (day 4)
Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
Exercise Capacity - Time to Exhaustion
Time frame: end-exercise value (Day 4)
Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)
5 secondary outcomes
Change in Central Cardiovascular Function - Cardiac Output
Time frame: end-exercise value (Day 4)
Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)
Time frame: Day 4
Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)
Time frame: Day 4
Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)
Time frame: Day 4
Change in Pulmonary Ventilation - Minute Ventilation (VE)
Time frame: end-exercise value (Day 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
J. Alberto Neder, MD, PhD principal investigator
Queen's University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetylcysteine in people with Pulmonary Disease, Chronic Obstructive, run by Queen's University.
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 1 inclusion and 8 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 14 Jun 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plasma Redox Status - Circulating Glutathione (time frame: pre-exercise value (day 4)). The study lists 2 primary outcomes in all. 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 14 Jun 2018.