Trial Outcomes & Findings for Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis (NCT NCT02088216)

Results Overview

An exacerbation of bronchiectasis is defined as either a change in one or more of the common symptoms of bronchiectasis (sputum volume or purulence, dyspnea, cough, and fatigue/malaise) or the onset of new symptoms (fever, pleurisy, haemoptysis or need for antibiotic treatment).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

161 participants

Primary outcome timeframe

12 months

Results posted on

2019-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	N-acetylcysteine Group Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group Participants received on-demand treatment.
Overall Study STARTED	81	80
Overall Study COMPLETED	69	70
Overall Study NOT COMPLETED	12	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.	Total n=161 Participants Total of all reporting groups
Age, Continuous	53.28 years STANDARD_DEVIATION 11.90 • n=81 Participants	56.56 years STANDARD_DEVIATION 12.41 • n=80 Participants	54.91 years STANDARD_DEVIATION 12.23 • n=161 Participants
Sex: Female, Male Female	45 Participants n=81 Participants	52 Participants n=80 Participants	97 Participants n=161 Participants
Sex: Female, Male Male	36 Participants n=81 Participants	28 Participants n=80 Participants	64 Participants n=161 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 months

An exacerbation of bronchiectasis is defined as either a change in one or more of the common symptoms of bronchiectasis (sputum volume or purulence, dyspnea, cough, and fatigue/malaise) or the onset of new symptoms (fever, pleurisy, haemoptysis or need for antibiotic treatment).

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Median Number of Exacerbations	1 exacerbations Interval 0.5 to 2.0	2 exacerbations Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: 12 months

The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.	-6.46 mL Standard Deviation 22.93	-18.28 mL Standard Deviation 25.69

SECONDARY outcome

Timeframe: 12 months

The values in the table were calculated as the value at baseline minus the value at 12 months.

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 12 months

Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores: the minimum value is 0 and the maximum value is 40. 0-10 points: "slight impact"; 11-20 points: "medium impact"; 21-30 points: "serious impact"; 31-40 points: "very serious impact". The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines	-3.79 score on a scale Standard Deviation 5.40	-1.44 score on a scale Standard Deviation 6.19

SECONDARY outcome

Timeframe: 12 months

The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines	1.16 percentage of predicted FEV1 Standard Deviation 16.50	0.13 percentage of predicted FEV1 Standard Deviation 7.78

SECONDARY outcome

Timeframe: 12 months

The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines	-0.10 L Standard Deviation 0.37	0.03 L Standard Deviation 0.16

SECONDARY outcome

Timeframe: 12 months

The change was calculated from two time points as the value at the later time point minus the value at the earlier time point.

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Change of Forced Vital Capacity (FVC) From Baselines	0.01 L Standard Deviation 0.46	0.03 L Standard Deviation 0.22

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Time to the First Exacerbation	140 days Interval 95.9 to 184.1	115 days Interval 77.75 to 152.25

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Time to Recurrent Exacerbations	313.70 days Interval 297.05 to 330.36	266.88 days Interval 244.6 to 289.15

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Nature of Sputum (Number of Patients With Yellow Purulent)	12 Participants	31 Participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	N-acetylcysteine Group n=81 Participants Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 Participants Participants received on-demand treatment.
Adverse Events (AEs) (Elevation of Liver Enzymes)	3 Participants	0 Participants

Adverse Events

N-acetylcysteine Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 2 deaths

Control Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	N-acetylcysteine Group n=81 participants at risk Participants received oral N-acetylcysteine (600 mg, twice daily, 12 months).	Control Group n=80 participants at risk Participants received on-demand treatment.
Gastrointestinal disorders Epigastric discomfort	9.9% 8/81 • Number of events 8 • 1 year.	7.5% 6/80 • Number of events 6 • 1 year.

Additional Information

Yu Li

Qilu Hospital of Shandong University

Phone: 13791122770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place