Chronic RhinosinusitisPhase 4NCT00318006
Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms
A Phase 4 study testing saline irrigation and saline spray in people with Chronic Rhinosinusitis, run by University of Michigan at 1 site in United States.
Trial summary
This study will compare nasal saline irrigation with nasal saline spray for the treatment of chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- saline irrigation and saline spray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Aug 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Presence of any one of the following symptoms for > 4 days/week and > 15 days in the past 1 month:
- Nasal stuffiness
- Nasal congestion
- Nasal dryness or crusting
- Abnormal nasal discharge
- Thick nasal discharge
Who cannot join
- Functional endoscopic sinus surgery (FESS) in the last 3 months
- Epistaxis in the last 3 months that required treatment
- Acute illness like otitis media, laryngitis, pharyngitis, or rhinitis in the last 2 weeks
- Acute attack of asthma or bronchitis in the last 2 weeks
- Inability to speak or read English
- Current use of any of the study medications regularly for more than a week in the last 1 month
- Any history of intolerance to saline treatment (if used)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms
This study will compare nasal saline irrigation with nasal saline spray for the treatment of chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Each participant will be instructed on how to perform daily nasal treatment.The subjects will complete follow-up surveys at regular intervals to assess any change in their nasal symptoms after starting nasal saline treatment. Participants may take their usual medications for sinus symptoms during their participation in the study.
Read the detailed description
See publication: Arch OtolaryngolHeadNeckSurg. 2007;133(11):1115-1120
- Conditions
- Chronic Rhinosinusitis
- Being tested
- saline irrigation, saline spray
- Keywords
- chronic, nasal, sinus, symptoms
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline irrigationProcedure or surgery
subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).
saline sprayProcedure or surgery
subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan).
| Study group | Role | What they receive |
|---|---|---|
| Spray | Active comparator | subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). Receives: Procedure: saline spray |
| Irrigation | Experimental | subjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). Receives: Procedure: saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean score of the sinonasal outcome test-20
Change in medication usage for nasal and sinus symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Responsible party
- Principal investigator, Melissa Pynnonen, University of Michigan
- Investigators
- Melissa A Pynnonen, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318006
- Sponsor's protocol ID
- HUM00000253
- Status last verified
- Jan 2015
- First submitted
- 21 Apr 2006
- Last updated
- 30 Jan 2015
- Results posted
- No
Publications
Pynnonen MA, Mukerji SS, Kim HM, Adams ME, Terrell JE. Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Arch Otolaryngol Head Neck Surg. 2007 Nov;133(11):1115-20. doi: 10.1001/archotol.133.11.1115.
PubMed 18025315
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms
- ClinicalTrials.gov ID
- NCT00318006
- Acronym / sponsor ID
- HUM00000253
- Conditions
- Chronic Rhinosinusitis
- Keywords
- chronic, nasal, sinus, symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Study start
- Dec 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 25 Apr 2006 (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.
This study will compare nasal saline irrigation with nasal saline spray for the treatment of chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Each participant will be instructed on how to perform daily nasal treatment.The subjects will complete follow-up surveys at regular intervals to assess any change in their nasal symptoms after starting nasal saline treatment. Participants may take their usual medications for sinus symptoms during their participation in the study.
Detailed description
See publication: Arch OtolaryngolHeadNeckSurg. 2007;133(11):1115-1120
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spray | Active comparator | Procedure: saline spraysubjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). |
| Irrigation | Experimental | Procedure: saline irrigationsubjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Presence of any one of the following symptoms for > 4 days/week and > 15 days in the past 1 month:
Key exclusion criteria (7 listed)
- Functional endoscopic sinus surgery (FESS) in the last 3 months
- Epistaxis in the last 3 months that required treatment
- Acute illness like otitis media, laryngitis, pharyngitis, or rhinitis in the last 2 weeks
- Acute attack of asthma or bronchitis in the last 2 weeks
- Inability to speak or read English
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 |
|---|---|---|
| saline irrigationsubjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). | Procedure or surgery | Irrigation |
| saline spraysubjects were instructed in the technique of nasal lavage (irrigation group) or nasal saline spray (spray group) and were asked to do the assigned treatment twice daily for 8 weeks. They were provided with an 8-week supply of materials (Sinus Rinse irrigations from NeilMed Products Inc, and Deep Sea nasal saline spray distributed by Major Pharmaceuticals, Livonia, Michigan). | Procedure or surgery | Spray |
Primary outcome
Change in the mean score of the sinonasal outcome test-20
Change in medication usage for nasal and sinus symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Derived from this study: PubMed 18025315Pynnonen MA, Mukerji SS, Kim HM, Adams ME, Terrell JE. Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Arch Otolaryngol Head Neck Surg. 2007 Nov;133(11):1115-20. doi: 10.1001/archotol.133.11.1115.
- Related InfoLink provided by the sponsor.
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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.
Melissa A Pynnonen, MD principal investigator
University of Michigan
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 saline irrigation and saline spray in people with Chronic Rhinosinusitis, run by University of Michigan at 1 site in United States.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jan 2015. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean score of the sinonasal outcome test-20. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00318006, which also lists 1 linked publication.
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 30 Jan 2015.