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

NCT00866866 | Unknown Phase 4

• 1 other identifier: 21571
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinonasal Symptoms

Outcome Measures

Primary Outcomes (1)

• Sinonasal Outcomes Test (SNOT) - 22

  6 weeks

Study Arms (2)

N-Acetyl Cysteine

EXPERIMENTAL

Drug: N-Acetyl Cysteine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

N-Acetyl Cysteine DRUG

600 mg PO BID

N-Acetyl Cysteine

Placebo DRUG

1 tab PO BID

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

RECRUITING

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Warren Yunker, MD, PhD

  University of Calgary

  STUDY DIRECTOR

Central Study Contacts

Brad Mechor, MD

CONTACT

(403) 944-3628; brad.mechor@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: March 23, 2009

Record last verified: 2009-03

Locations

CA (1)