Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-04 @ 4:40 PM
Study NCT ID:
NCT00866866
Status:
UNKNOWN
Last Update Posted:
2009-03-23
First Post:
2009-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-20', 'studyFirstSubmitDate': '2009-03-20', 'studyFirstSubmitQcDate': '2009-03-20', 'lastUpdatePostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sinonasal Outcomes Test (SNOT) - 22', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Sinonasal Symptoms']}, 'descriptionModule': {'briefSummary': "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.\n\nCSNS 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* poorly controlled asthma\n* cystic fibrosis\n* chronic obstructive pulmonary disease (COPD)\n* severe coronary artery disease\n* vasculopathy\n* poorly controlled diabetes\n* poorly controlled hypertension\n* women who are breastfeeding'}, 'identificationModule': {'nctId': 'NCT00866866', 'briefTitle': 'The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '21571'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'N-Acetyl Cysteine', 'interventionNames': ['Drug: N-Acetyl Cysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'N-Acetyl Cysteine', 'type': 'DRUG', 'description': '600 mg PO BID', 'armGroupLabels': ['N-Acetyl Cysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tab PO BID', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brad Mechor, MD', 'role': 'CONTACT', 'phone': '(403) 944-3628'}, {'name': 'Brad Mechor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': 'Brad Mechor, MD', 'role': 'CONTACT', 'email': 'brad.mechor@albertahealthservices.ca', 'phone': '(403) 944-3628'}], 'overallOfficials': [{'name': 'Warren Yunker, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Calgary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. B. Mechor', 'oldOrganization': 'University of Calgary'}}}}