Recruiting

N-Acetyl Cysteine

Sponsor:

University of Calgary

Code:

NCT00866866

Conditions

Chronic Sinonasal Symptoms

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

N-Acetyl Cysteine

Placebo

Study Details

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

Study ID

NCT00866866

Start date

Mar, 2009

Status verified date

Mar, 2009

Completion date

May, 2010

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: N-Acetyl Cysteine

placebo comparator: Placebo

Interventions

N-Acetyl Cysteine

600 mg PO BID

Placebo

1 tab PO BID

Primary outcome measure

  • Sinonasal Outcomes Test (SNOT) - 22 [ Time Frame: 6 weeks ]

Central Contacts and Locations

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada

Contacts

Brad Mechor, MD

(403) 944-3628

Principal Investigator:

Brad Mechor, MD

More Information

Sponsor

University of Calgary

Last update posted

Mar 23, 2009

Last verified

Mar, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2009-03-23.