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

The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Sinonasal Symptoms
• Intervention / Treatment: Drug: N-Acetyl Cysteine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brad Mechor, MD; Phone Number: (403) 944-3628; Email: brad.mechor@albertahealthservices.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • University of Calgary
      • Contact: Brad Mechor, MD; Phone Number: (403) 944-3628
      • Principal Investigator: Brad Mechor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; 1 tab PO BID
EXPERIMENTAL: N-Acetyl Cysteine	Drug: N-Acetyl Cysteine; 600 mg PO BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sinonasal Outcomes Test (SNOT) - 22	6 weeks

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Study Director: Warren Yunker, MD, PhD, University of Calgary

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2009
• Study Completion (ANTICIPATED): May 1, 2010

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (ESTIMATE): March 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 23, 2009
• Last Update Submitted That Met QC Criteria: March 20, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: 21571