RhinitisNCT01030146
Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline
A study testing NeilMed® Sinus Rinse™ System with Isotonic Saline in people with Rhinitis, run by Medical University of South Carolina at 1 site in United States.
Trial summary
You are being asked to volunteer for a research study. You are being asked to participate in this study because you have completed at least one month of drug treatment with a nasal steroid and allergy testing and still have symptoms. This research study is sponsored by NeilMed Pharmaceuticals, Inc. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rhinitis
- What is being tested?
- NeilMed® Sinus Rinse™ System with Isotonic Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2013
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female adults (aged 18-99) diagnosed with rhinitis who have completed one month of pharmacotherapy exclusively with nasal steroids and allergy testing.
Who cannot join
- male and female adults who have been diagnosed with sinusitis, cystic fibrosis, or immune deficiency or those unable or unwilling to perform saline irrigations for two months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinus Center - Medical Univesity of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline: A Prospective Pilot Study
You are being asked to volunteer for a research study. You are being asked to participate in this study because you have completed at least one month of drug treatment with a nasal steroid and allergy testing and still have symptoms. This research study is sponsored by NeilMed Pharmaceuticals, Inc. The purpose of this study is to compare quality of life outcomes in patients who continue medical treatment plus the use of the NeilMed Sinus Rinse low-pressure pump with saline. Your participation in this study may help to improve the management of patients with allergic rhinitis.
Allergic rhinitis is a common health problem, affecting between 10% and 40% of the world's population. Presently, antihistamines and nasal steroids are the standard treatment for allergic rhinitis. To further clarify these findings, we propose a study comparing the differences in quality of life improvements, by using a series of questionnaires, between subjects electing continued medical management and those electing medical treatment plus nasal wash.
The investigators in charge of the study are Dr. Rodney J. Schlosser and Dr. Shaun A. Nguyen. Approximately 40 patients will be enrolled in this study at the Medical University of South Carolina (MUSC Hospital). You will have the choice of choosing either to receive only medical treatment or to receive medical treatment with nasal wash.
Read the detailed description
Before you are allowed to participate in this study, the doctor will review your medical history and ask you questions to see if you qualify for the study.
This study follows the standard of care in managing patients with allergic rhinitis. You will undergo allergy testing with the skin prick test (SPT), a baseline NPIF (Nasal Peak Inspiratory Flow, where we ask you to breath in a mask) measurement, and a baseline assessment with the mRQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) questionnaire. You will be asked to continue drug treatment with nasal steroid along with the NeilMed Sinus Rinse low-pressure pump with isotonic saline as an add-on treatment. You will be given supplies and instructions on the use of the NeilMed Sinus Rinse low-pressure pump with saline to be performed twice a day for two months. You will be asked to come back at the end of 1 month and 2 months, where you will complete another mRQLQ and NPIF assessment. In addition, you will be asked to return low-pressure nasal irrigation bottle for testing of bacteria and fungi at the end of 1 month and 2 months. This is a safety assessment for back wash contamination.
If you are unable to return for scheduled clinic visits, questionnaires will be mailed with self-addressed stamped envelopes with follow-up phone calls to ensure study compliance and minimal attrition C. Duration The time to answer the survey questionnaires will take no longer than 20 minutes on each visit. The entire duration of the study is no longer than 8 weeks
- Conditions
- Rhinitis
- Being tested
- NeilMed® Sinus Rinse™ System with Isotonic Saline
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeilMed® Sinus Rinse™ System with Isotonic SalineDrug
NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day
| Study group | Role | What they receive |
|---|---|---|
| NeilMed® Sinus Rinse™ System | Other | NeilMed® Sinus Rinse™ System with Isotonic Saline twice a day Receives: Drug: NeilMed® Sinus Rinse™ System with Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRQLQ
Measured: 8 weeks
Secondary outcomes (2)
Nasal Peak Inspiratory Flow
Measured: 8 weeks
Safety and Adverse Effects
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RhinitisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Rodney J Schlosser, MD, Principal investigator, Medical University of South CarolinaShaun A Nguyen, M.D.,CPI, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030146
- Sponsor's protocol ID
- Sinus Rinse
- Status last verified
- Aug 2014
- First submitted
- 9 Dec 2009
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nguyen SA, Camilon MP, Schlosser RJ. Identification of microbial contaminants in sinus rinse squeeze bottles used by allergic rhinitis patients. World J Otorhinolaryngol Head Neck Surg. 2019 Jan 5;5(1):26-29. doi: 10.1016/j.wjorl.2018.12.001. eCollection 2019 Mar.
PubMed 30775698Nguyen SA, Psaltis AJ, Schlosser RJ. Isotonic saline nasal irrigation is an effective adjunctive therapy to intranasal corticosteroid spray in allergic rhinitis. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):308-11. doi: 10.2500/ajra.2014.28.4066. Epub 2014 May 22.
PubMed 24857280
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT01030146
- Acronym / sponsor ID
- Sinus Rinse
- Conditions
- Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- NeilMed Pharmaceuticals
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Dec 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.
You are being asked to volunteer for a research study. You are being asked to participate in this study because you have completed at least one month of drug treatment with a nasal steroid and allergy testing and still have symptoms. This research study is sponsored by NeilMed Pharmaceuticals, Inc. The purpose of this study is to compare quality of life outcomes in patients who continue medical treatment plus the use of the NeilMed Sinus Rinse low-pressure pump with saline. Your participation in this study may help to improve the management of patients with allergic rhinitis.
Allergic rhinitis is a common health problem, affecting between 10% and 40% of the world's population. Presently, antihistamines and nasal steroids are the standard treatment for allergic rhinitis. To further clarify these findings, we propose a study comparing the differences in quality of life improvements, by using a series of questionnaires, between subjects electing continued medical management and those electing medical treatment plus nasal wash.
The investigators in charge of the study are Dr. Rodney J. Schlosser and Dr. Shaun A. Nguyen. Approximately 40 patients will be enrolled in this study at the Medical University of South Carolina (MUSC Hospital). You will have the choice of choosing either to receive only medical treatment or to receive medical treatment with nasal wash.
Detailed description
Before you are allowed to participate in this study, the doctor will review your medical history and ask you questions to see if you qualify for the study.
This study follows the standard of care in managing patients with allergic rhinitis. You will undergo allergy testing with the skin prick test (SPT), a baseline NPIF (Nasal Peak Inspiratory Flow, where we ask you to breath in a mask) measurement, and a baseline assessment with the mRQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) questionnaire. You will be asked to continue drug treatment with nasal steroid along with the NeilMed Sinus Rinse low-pressure pump with isotonic saline as an add-on treatment. You will be given supplies and instructions on the use of the NeilMed Sinus Rinse low-pressure pump with saline to be performed twice a day for two months. You will be asked to come back at the end of 1 month and 2 months, where you will complete another mRQLQ and NPIF assessment. In addition, you will be asked to return low-pressure nasal irrigation bottle for testing of bacteria and fungi at the end of 1 month and 2 months. This is a safety assessment for back wash contamination.
If you are unable to return for scheduled clinic visits, questionnaires will be mailed with self-addressed stamped envelopes with follow-up phone calls to ensure study compliance and minimal attrition C. Duration The time to answer the survey questionnaires will take no longer than 20 minutes on each visit. The entire duration of the study is no longer than 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeilMed® Sinus Rinse™ System | Other | Drug: NeilMed® Sinus Rinse™ System with Isotonic SalineNeilMed® Sinus Rinse™ System with Isotonic Saline twice a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female adults (aged 18-99) diagnosed with rhinitis who have completed one month of pharmacotherapy exclusively with nasal steroids and allergy testing.
Key exclusion criteria (1 listed)
- male and female adults who have been diagnosed with sinusitis, cystic fibrosis, or immune deficiency or those unable or unwilling to perform saline irrigations for two months.
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 |
|---|---|---|
| NeilMed® Sinus Rinse™ System with Isotonic SalineNeilMed® Sinus Rinse™ System with Isotonic Saline twice a day | Drug | NeilMed® Sinus Rinse™ System |
Primary outcome
mRQLQ
Time frame: 8 weeks
2 secondary outcomes
Nasal Peak Inspiratory Flow
Time frame: 8 weeks
Safety and Adverse Effects
Time frame: 8 weeks
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 23 Jul 2018.
- Derived from this study: PubMed 30775698Nguyen SA, Camilon MP, Schlosser RJ. Identification of microbial contaminants in sinus rinse squeeze bottles used by allergic rhinitis patients. World J Otorhinolaryngol Head Neck Surg. 2019 Jan 5;5(1):26-29. doi: 10.1016/j.wjorl.2018.12.001. eCollection 2019 Mar.
- Derived from this study: PubMed 24857280Nguyen SA, Psaltis AJ, Schlosser RJ. Isotonic saline nasal irrigation is an effective adjunctive therapy to intranasal corticosteroid spray in allergic rhinitis. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):308-11. doi: 10.2500/ajra.2014.28.4066. Epub 2014 May 22.
- PubMedLink provided by the sponsor.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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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.
Rodney J Schlosser, MD principal investigator
Medical University of South Carolina
Shaun A Nguyen, M.D.,CPI principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeilMed® Sinus Rinse™ System with Isotonic Saline in people with Rhinitis, run by Medical University of South Carolina 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 1 inclusion and 1 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 23 Jul 2018. 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.
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?
mRQLQ (time frame: 8 weeks). 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 NCT01030146, which also lists 2 linked publications.
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 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.