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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of Calgary.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00866866
First received: March 20, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Sinonasal Symptoms
Drug: N-Acetyl Cysteine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Sinonasal Outcomes Test (SNOT) - 22 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-Acetyl Cysteine Drug: N-Acetyl Cysteine
600 mg PO BID
Placebo Comparator: Placebo Drug: Placebo
1 tab PO BID

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866866

Contacts
Contact: Brad Mechor, MD (403) 944-3628 brad.mechor@albertahealthservices.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Brad Mechor, MD    (403) 944-3628      
Principal Investigator: Brad Mechor, MD         
Sponsors and Collaborators
University of Calgary
Investigators
Study Director: Warren Yunker, MD, PhD University of Calgary
  More Information

No publications provided

Responsible Party: Dr. B. Mechor, University of Calgary
ClinicalTrials.gov Identifier: NCT00866866     History of Changes
Other Study ID Numbers: 21571
Study First Received: March 20, 2009
Last Updated: March 20, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on April 15, 2014