Chronic Sinonasal SymptomsPhase 4NCT00866866
The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms
A Phase 4 study testing N-Acetyl Cysteine in people with Chronic Sinonasal Symptoms, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Sinonasal Symptoms
- What is being tested?
- N-Acetyl Cysteine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2009to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
Brad Mechor, MD, (403) 944-3628
Brad Mechor, MD
About this study
Official title: The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
- Conditions
- Chronic Sinonasal Symptoms
- Being tested
- N-Acetyl Cysteine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl CysteineDrug
600 mg PO BID
PlaceboDrug
1 tab PO BID
| Study group | Role | What they receive |
|---|---|---|
| N-Acetyl Cysteine | Experimental | Not described Receives: Drug: N-Acetyl Cysteine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal Outcomes Test (SNOT) - 22
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Sinonasal SymptomsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Investigators
- Warren Yunker, MD, PhD, Study director, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866866
- Sponsor's protocol ID
- 21571
- Status last verified
- Mar 2009
- First submitted
- 20 Mar 2009
- Last updated
- 23 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Oral N-Acetyl Cysteine for the Treatment of Chronic Sinonasal Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00866866
- Acronym / sponsor ID
- 21571
- Conditions
- Chronic Sinonasal Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 23 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetyl Cysteine | Experimental | Drug: N-Acetyl Cysteine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- poorly controlled asthma
- cystic fibrosis
- chronic obstructive pulmonary disease (COPD)
- severe coronary artery disease
- vasculopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl Cysteine600 mg PO BID | Drug | N-Acetyl Cysteine |
| Placebo1 tab PO BID | Drug | Placebo |
Primary outcome
Sinonasal Outcomes Test (SNOT) - 22
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Yunker, MD, PhD study director
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-Acetyl Cysteine in people with Chronic Sinonasal Symptoms, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brad Mechor, MD ((403) 944-3628, brad.mechor@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal Outcomes Test (SNOT) - 22 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2009.