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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Sinonasal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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N-Acetyl Cysteine

Group Type EXPERIMENTAL

N-Acetyl Cysteine

Intervention Type DRUG

600 mg PO BID

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tab PO BID

Interventions

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N-Acetyl Cysteine

600 mg PO BID

Intervention Type DRUG

Placebo

1 tab PO BID

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes