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Sponsored by: |
University of Calgary |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00866866 |
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 IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial |
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 |
---|---|
N-Acetyl Cysteine: Experimental |
Drug: N-Acetyl Cysteine
600 mg PO BID
|
Placebo: Placebo Comparator |
Drug: Placebo
1 tab PO BID
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brad Mechor, MD | (403) 944-3628 | brad.mechor@albertahealthservices.ca |
Canada, Alberta | |
University of Calgary | Recruiting |
Calgary, Alberta, Canada | |
Contact: Brad Mechor, MD (403) 944-3628 | |
Principal Investigator: Brad Mechor, MD |
Study Director: | Warren Yunker, MD, PhD | University of Calgary |
Responsible Party: | University of Calgary ( Dr. B. Mechor ) |
Study ID Numbers: | 21571 |
Study First Received: | March 20, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00866866 History of Changes |
Health Authority: | Canada: Health Canada |
Anti-Infective Agents Antioxidants Cysteine Expectorants |
Acetylcysteine Antiviral Agents N-monoacetylcystine |
Respiratory System Agents Anti-Infective Agents Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antiviral Agents Protective Agents |
Pharmacologic Actions Expectorants Therapeutic Uses Free Radical Scavengers Acetylcysteine N-monoacetylcystine Antidotes |