Trial Outcomes & Findings for N-Acetylcysteine for Patients With COPD and Chronic Bronchitis (NCT NCT01739790)
NCT ID: NCT01739790
Last Updated: 2017-09-13
Results Overview
The St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2017-09-13
Participant Flow
Participant milestones
| Measure |
Placebo
Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
|
N-Acetylcysteine
1800 mg twice daily for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
22
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
|
N-Acetylcysteine
1800 mg twice daily for 8 weeks
|
|---|---|---|
|
Overall Study
Early Trial Termination
|
2
|
4
|
Baseline Characteristics
N-Acetylcysteine for Patients With COPD and Chronic Bronchitis
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=22 Participants
Identical placebo pills twice daily for 8 weeks Placebo pills manufactured to mimic appearance of intervention drug n-acetylcysteine and prescribed with identical frequency and duration.
Placebo: Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
|
N-Acetylcysteine
n=23 Participants
1800 mg twice daily for 8 weeks
N-Acetylcysteine: 1800 mg twice daily for 8 weeks
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 Years
n=5 Participants
|
70.1 Years
n=7 Participants
|
69.5 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksThe St. George's Respiratory Questionnaire (SGRQ) is scored on a scale of 1 to 100 with 100 representing the worst respiratory health status. The instrument is self-administered at baseline and again after 8-weeks of treatment.
Outcome measures
| Measure |
Placebo
n=22 Participants
Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
|
N-Acetylcysteine
n=23 Participants
1800 mg twice daily for 8 weeks
|
|---|---|---|
|
Changes in the Saint George's Respiratory Questionnaire
Change in SGRQ Total
|
-7.1 units on a scale
Standard Deviation 16.1
|
-3.9 units on a scale
Standard Deviation 12.1
|
|
Changes in the Saint George's Respiratory Questionnaire
Change in SGRQ Symptoms
|
-9.8 units on a scale
Standard Deviation 17.8
|
-3.5 units on a scale
Standard Deviation 18.6
|
|
Changes in the Saint George's Respiratory Questionnaire
Change in SGRQ Activity
|
-3.7 units on a scale
Standard Deviation 14.5
|
-4.0 units on a scale
Standard Deviation 13.6
|
|
Changes in the Saint George's Respiratory Questionnaire
Change in SGRQ Impact
|
-7.5 units on a scale
Standard Deviation 20.1
|
-4.5 units on a scale
Standard Deviation 19.9
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
N-Acetylcysteine
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=22 participants at risk
Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
|
N-Acetylcysteine
n=23 participants at risk
1800 mg twice daily for 8 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
9.1%
2/22 • Number of events 3
|
8.7%
2/23 • Number of events 2
|
Other adverse events
| Measure |
Placebo
n=22 participants at risk
Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
|
N-Acetylcysteine
n=23 participants at risk
1800 mg twice daily for 8 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rotator cuff repair
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
|
Social circumstances
Alcohol abuse
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
|
Musculoskeletal and connective tissue disorders
Ruptured Baker's cyst
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
13.6%
3/22 • Number of events 3
|
21.7%
5/23 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
1/22 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Worsening Dyspnea
|
9.1%
2/22 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
Reproductive system and breast disorders
Breast tenderness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
|
Respiratory, thoracic and mediastinal disorders
Increased shortness of breath
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Edema
|
9.1%
2/22 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Urinary Tract Infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/23
|
|
Blood and lymphatic system disorders
Weight Loss
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Face rash
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Hepatobiliary disorders
Worsening Prostatitis
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Renal and urinary disorders
Urethral stricture
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Abdominal pain
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
|
Immune system disorders
Influenza
|
0.00%
0/22
|
4.3%
1/23 • Number of events 1
|
Additional Information
Dennis E. Niewoehner, MD
Minneapolis VA Healthcare System
Phone: 612-467-4412
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place