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

University of Calgary

Status and phase: Unknown; Phase 4

Conditions: Chronic Sinonasal Symptoms

Treatments: Drug: N-Acetyl Cysteine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00866866

21571

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

60 participants in 2 patient groups, including a placebo group

N-Acetyl Cysteine

Experimental group

Treatment:

Drug: N-Acetyl Cysteine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo