Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02088216
• Date of registration: 05/03/2014
• Prospective Registration: Yes
• Primary sponsor: Qilu Hospital of Shandong University
• Public title: Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis BENE
• Scientific title: Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial
• Date of first enrolment: April 1, 2014
• Target sample size: 161
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02088216
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Yu Li, Professor
• Affiliation: Director

Key inclusion & exclusion criteria

Inclusion Criteria:

1. subjects were aged 18-80 years old;

2. a diagnosis of idiopathic or post-infective bronchiectasis was made;

3. patients had at least two exacerbations in the past year and were in a stable state
for at least 4 weeks prior to the primary enrollment.

Exclusion Criteria:

Patients were excluded if they fulfilled any of the following criteria: current smokers;
cigarette smoking within 6 months; cystic fibrosis or other etiologies (such as
immunodeficiency, allergic bronchopulmonary aspergillosis, traction bronchiectasis caused
by emphysema, advanced pulmonary fibrosis, etc.); pulmonary function test results showing a
forced expiratory volume in 1 s (FEV1) = 30% of the predicted value; a history of severe
cardiovascular or neurological disease; comorbidity with liver disease, kidney disease,
malignant tumor, gastric ulcer, or intestinal malabsorption; a known allergy to
N-acetylcysteine; pregnancy or lactation (for women); a history of prior macrolide use of
more than 1 week; and poor compliance.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-Cystic Fibrosis Bronchiectasis

Intervention(s)

Other: On-demand treatment

Drug: N-acetylcysteine

Primary Outcome(s)

Median Number of Exacerbations [Time Frame: 12 months]

Secondary Outcome(s)

Change of Forced Vital Capacity (FVC) From Baselines [Time Frame: 12 months]

Nature of Sputum (Number of Patients With Yellow Purulent) [Time Frame: 12 months]

Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines [Time Frame: 12 months]

Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up. [Time Frame: 12 months]

Adverse Events (AEs) (Elevation of Liver Enzymes) [Time Frame: 12 months]

Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines [Time Frame: 12 months]

Time to the First Exacerbation [Time Frame: 12 months]

Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines [Time Frame: 12 months]

Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa [Time Frame: 12 months]

Time to Recurrent Exacerbations [Time Frame: 12 months]

Secondary ID(s)

NCFB-FLS-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/02/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02088216