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

Sponsor

University of Calgary (Other)

Overall Status

Unknown status

CT.gov ID

NCT00866866

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Sinonasal Symptoms	Drug: N-Acetyl Cysteine Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: N-Acetyl Cysteine	Drug: N-Acetyl Cysteine 600 mg PO BID
Placebo Comparator: Placebo	Drug: Placebo 1 tab PO BID

Arm

Intervention/Treatment

Experimental: N-Acetyl Cysteine

Drug: N-Acetyl Cysteine

600 mg PO BID

Placebo Comparator: Placebo

Drug: Placebo

1 tab PO BID

Outcome Measures

Primary Outcome Measures

Sinonasal Outcomes Test (SNOT) - 22 [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Calgary	Calgary	Alberta	Canada

Sponsors and Collaborators

University of Calgary

Investigators

Study Director: Warren Yunker, MD, PhD, University of Calgary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00866866

Other Study ID Numbers:

21571

First Posted:

Mar 23, 2009

Last Update Posted:

Mar 23, 2009

Last Verified:

Mar 1, 2009

Additional relevant MeSH terms:

Acetylcysteine

N-monoacetylcystine

Study Results

No Results Posted as of Mar 23, 2009