Trial Outcomes & Findings for Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction (NCT NCT02579772)

NCT ID: NCT02579772

Last Updated: 2018-06-14

Results Overview

Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: pre-exercise value (day 4)
• Results posted on: 2018-06-14

Participant Flow

Participant milestones

Measure	N-acetylcysteine, Then Placebo Participants first received 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). After a washout period of at least 7 days, they then received 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.	Placebo, Then N-acetylcysteine Participants first received 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment. After a washout period of at least 7 days, they then received 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).
Overall Study STARTED	8	5
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	N-acetylcysteine, Then Placebo Participants first received 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). After a washout period of at least 7 days, they then received 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.	Placebo, Then N-acetylcysteine Participants first received 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment. After a washout period of at least 7 days, they then received 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).
Overall Study Withdrawal by Subject	0	1
Overall Study Usage of additional antioxidants	1	0
Overall Study flu-like illness, orthopedic trauma	1	1

Baseline Characteristics

Effects of N-acetylcysteine on Cardiorespiratory Control in COPD Patients With Mild-to-moderate Airflow Obstruction

Baseline characteristics by cohort

Measure	All Study Participants n=9 Participants Participants who were randomized to receive either N-acetylcysteine (NAC) or placebo pills
Age, Continuous	67 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: pre-exercise value (day 4)

Fluorescent detection of plasma glutathione from samples collected during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Outcome measures

Measure	N-acetylcysteine n=9 Participants 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.	Placebo n=9 Participants 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Plasma Redox Status - Circulating Glutathione	8.97 micromolar Standard Error 0.61	7.05 micromolar Standard Error 0.49

PRIMARY outcome

Timeframe: end-exercise value (Day 4)

Cycling time to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Outcome measures

Measure	N-acetylcysteine n=9 Participants 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.	Placebo n=9 Participants 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Exercise Capacity - Time to Exhaustion	336 seconds Standard Error 51	325 seconds Standard Error 47

SECONDARY outcome

Timeframe: end-exercise value (Day 4)

During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Outcome measures

Measure	N-acetylcysteine n=9 Participants 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.	Placebo n=9 Participants 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Change in Central Cardiovascular Function - Cardiac Output	12.5 liters/min Standard Error 1.0	12.1 liters/min Standard Error 0.9

SECONDARY outcome

Timeframe: Day 4

Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Outcome measures

Measure	N-acetylcysteine n=9 Participants 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.	Placebo n=9 Participants 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Change in Skeletal Muscle Deoxygenation - Dynamics (Mean Response Time)	19.0 seconds Standard Error 1.3	19.0 seconds Standard Error 2.5

SECONDARY outcome

Timeframe: Day 4

Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Outcome measures

Measure	N-acetylcysteine n=9 Participants 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.	Placebo n=9 Participants 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Change in Skeletal Muscle Vascular Function - Capillary Blood Flow Dynamics (Mean Response Time)	65.4 seconds Standard Error 4.6	66.5 seconds Standard Error 7.6

SECONDARY outcome

Timeframe: Day 4

Mean response time (MRT) evaluated during cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Outcome measures

Measure	N-acetylcysteine n=9 Participants 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.	Placebo n=9 Participants 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Change in Pulmonary Oxygen Uptake - Dynamics (Mean Response Time)	63.0 seconds Standard Error 5.2	62.2 seconds Standard Error 4.4

SECONDARY outcome

Timeframe: end-exercise value (Day 4)

During cycling to exhaustion during day 4 of each experimental arm (placebo vs. N-acetylcysteine)

Outcome measures

Measure	N-acetylcysteine n=9 Participants 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.	Placebo n=9 Participants 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Change in Pulmonary Ventilation - Minute Ventilation (VE)	78.7 liters/min Standard Error 7.6	75.8 liters/min Standard Error 6.6

Adverse Events

N-acetylcysteine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	N-acetylcysteine n=9 participants at risk 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.	Placebo n=9 participants at risk 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
Gastrointestinal disorders bloating, intestinal gas	11.1% 1/9 • Number of events 1 • Adverse event data collected over the 4-day treatment period (NAC and placebo).	0.00% 0/9 • Adverse event data collected over the 4-day treatment period (NAC and placebo).

Additional Information

Dr. J. Alberto Neder

Queen's University

Phone: 613-548-2255

Email: nederalb@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place