N/A N=161 Randomized Treatment

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

Non-Cystic Fibrosis Bronchiectasis

Bottom Line

View on ClinicalTrials.gov: NCT02088216 ↗

Enrolled (actual)

161

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Median Number of Exacerbations — 1; 2 exacerbations

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: N-acetylcysteine (Drug); On-demand treatment (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Qilu Hospital of Shandong University
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Number of Exacerbations	1; 2	—
SECONDARY Change of Volume of Sputum From Baseline Parameters After the 12-month Follow-up.	-6.46; -18.28	—
SECONDARY Change of Number of Patients With a Positive Sputum Culture for Pseudomonas Aeruginosa	8; 5	—
SECONDARY Change of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) Scores From Baselines	-3.79; -1.44	—
SECONDARY Change in Percentage of Predicted Forced Expiratory Volume in One Second (FEV1%) From Baselines	1.16; 0.13	—
SECONDARY Change of Forced Expiratory Volume in One Second (FEV1) (L) From Baselines	-0.10; 0.03	—
SECONDARY Change of Forced Vital Capacity (FVC) From Baselines	0.01; 0.03	—
SECONDARY Time to the First Exacerbation	140; 115	—
SECONDARY Time to Recurrent Exacerbations	313.70; 266.88	—
SECONDARY Nature of Sputum (Number of Patients With Yellow Purulent)	12; 31	—
SECONDARY Adverse Events (AEs) (Elevation of Liver Enzymes)	3; 0	—

Summary

Objective: To evaluate whether long-term oral N-acetylcysteine as an expectorant drug can reduce the frequency of acute exacerbations of patients with non-cystic fibrosis bronchiectasis and improve their quality of life. Methods: Patients with non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive 600 mg of oral N-acetylcysteine BID for 12 months) or the control group (participants receive oral tablet BID for 12 months). The primary endpoint was the frequency of acute exacerbations. Expected results: Compared with the control group, the frequency of acute exacerbations of the observer Group will decrease significantly. Hypothesis: Long-term oral N-acetylcysteine can reduce the frequency of acute exacerbations of patients with non-cystic fibrosis bronchiectasis and improve their quality of life.

Eligibility Criteria

Inclusion Criteria

subjects were aged 18-80 years old;
a diagnosis of idiopathic or post-infective bronchiectasis was made;
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02088216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.