The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms

Phase 4

• Conditions: Chronic Sinonasal Symptoms
• Interventions: Drug: N-Acetyl Cysteine; Drug: Placebo

• Registration Number: NCT00866866
• Lead Sponsor: University of Calgary

Brief Summary

Chronic sinonasal symptoms (CSNS), such as coughing, throat clearing, nasal obstruction, crusting, dryness and discharge are extremely common in the general population. Although the physical symptoms are readily apparent, the psychosocial impact is often overlooked. Depression, anxiety, fear of social interaction, impaired personal relationships and decreased performance at work have all been associated with CSNS, often leading to multiple, frequent visits to the patient's primary care physician. A variety of clinical studies have shown that health-related quality of life (HRQoL) is significantly impaired in people with CSNS, with depressive symptoms being particularly common.

CSNS may be due, in part, to tenacious nasal and paranasal secretions. It is therefore conceivable that a mucolytic may thin these secretions and improve mucociliary clearance, thereby reducing CSNS. N-acetylcysteine (NAC) is the most widely used mucolytic agent, particularly in patients with cystic fibrosis (CF), and has been documented as the most effective of the mucokinetic agents. Our group wishes to examine the use of NAC as a treatment for CSNS by testing the hypothesis that oral NAC reduces symptoms of CSNS compared to placebo.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-03
• Study Start: 2009-03
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Last Update Submitted: 2009-03-20
• Study First Posted: 2009-03-23
• Last Update Posted: 2009-03-23
• Primary Completion: 2009-12
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• one or more the following symptoms: nasal stuffiness, nasal dryness or crusting, nasal congestion, discolored nasal discharge, or thick nasal discharge, for four or more days a week in the preceding two weeks

Exclusion Criteria

• poorly controlled asthma
• cystic fibrosis
• chronic obstructive pulmonary disease (COPD)
• severe coronary artery disease
• vasculopathy
• poorly controlled diabetes
• poorly controlled hypertension
• women who are breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-Acetyl Cysteine	N-Acetyl Cysteine	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Sinonasal Outcomes Test (SNOT) - 22	6 weeks

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada