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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00866866
Enrollment
60
Registered
2009-03-23
Start date
2009-03-31
Completion date
2010-05-31
Last updated
2009-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Sinonasal Symptoms

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.

Interventions

DRUGN-Acetyl Cysteine

600 mg PO BID

DRUGPlacebo

1 tab PO BID

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Sinonasal Outcomes Test (SNOT) - 226 weeks

Countries

Canada

Contacts

Primary ContactBrad Mechor, MD
brad.mechor@albertahealthservices.ca(403) 944-3628

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026