Nasal Saline Irrigation for Pituitary Disease

(NOSE Trial)

Recruiting at 1 trial location

Overseen By Val Calores

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lori Wood

Must not be taking: Antibiotics

Disqualifiers: Sinusitis, Asthma, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, single-blinded, multicenter study evaluating the benefit of sinonasal irrigations following endoscopic pituitary surgery. The goal of this study is to create practice changing guidelines with objective data highlighting the importance of irrigations on postoperative outcomes for pituitary surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on antibiotics for another condition, you may not be eligible to participate.

What data supports the effectiveness of the treatment Nasal Saline Irrigation for Pituitary Disease?

Research shows that nasal saline irrigation can help improve symptoms and quality of life in people with sinonasal conditions like chronic rhinosinusitis, suggesting it may also be beneficial for pituitary disease-related nasal issues. ^{1 2 3 4 5}

Is nasal saline irrigation safe for humans?

Nasal saline irrigation is generally considered safe for humans, with no serious adverse events reported. Minor side effects like nasal discomfort can occur but are usually avoidable with proper technique and adjustments. ^{5 6 7 8 9}

How is nasal saline irrigation unique for treating pituitary disease?

Nasal saline irrigation is unique for treating pituitary disease because it involves rinsing the nasal passages with a saline solution, which is different from typical drug treatments. This method is commonly used for sinonasal conditions and is considered safe, with no serious side effects, making it a novel approach for managing symptoms related to pituitary disease. ^{1 4 6 10 11}

Eligibility Criteria

This trial is for adults aged 18-85 who are undergoing endoscopic surgery to remove pituitary tumors. Participants must speak English and be able to understand specific nasal condition questionnaires. They should not have any conditions that make joining the study risky, as judged by the investigator.

Inclusion Criteria

I have been diagnosed with a specific type of pituitary tumor or cyst.

Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable

English speaking and able to understand the ASK Nasal-12 and SNOT-22 scales

Exclusion Criteria

Allergic rhinitis

I have asthma.

I am currently taking antibiotics for a condition other than cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic pituitary surgery followed by either standard postoperative nasal care with saline irrigations or no saline irrigations

12 weeks

Regular follow-ups at 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks

Follow-up

Participants are monitored for sinonasal quality of life and endoscopy findings post-treatment

12 weeks

Follow-up assessments at 1 week, 4 weeks, and 12 weeks

Treatment Details

Interventions

• Nasal Saline Irrigation

Trial Overview The study is testing if nasal saline irrigation helps patients recover after endonasal pituitary surgery. It's a forward-looking, single-blinded test across multiple centers aiming to set new guidelines based on how these irrigations affect post-surgery recovery.

Participant Groups

Group I: Nasal saline irrigation Active Control 1 Intervention

Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations

Group II: No Intervention Active Control 1 Intervention

Patients randomized to not performing saline sinonasal irrigations.

Who Is Running the Clinical Trial?

Lori Wood

Lead Sponsor

Trials

1

Recruited

140+

Nicole Hill

Lead Sponsor

Trials

2

Recruited

170+

Barrow Brain and Spine

Collaborator

Trials

2

Recruited

170+

Findings from Research

Saline nasal irrigation effectively promotes mucociliary clearance, helping to moisturize the nasal cavity and remove debris, making it a beneficial treatment for sinonasal conditions.

This method is safe for both adults and children, has no serious adverse effects, and is recommended in treatment guidelines for rhinosinusitis, potentially reducing reliance on medications and minimizing antibiotic resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation: Its role as an adjunct treatment. Papsin, B., McTavish, A.[2018]

Nasal saline irrigations (NSI) significantly improved nasal and general symptoms in patients with chronic rhinosinusitis with nasal polyps after endonasal sinus surgery, with mean symptom scores of 4.4 in the irrigation group compared to 6.3 in the non-irrigation group.

Despite the improvement in symptoms, NSI did not affect the postoperative condition of the mucosa or the number of missed workdays after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. Giotakis, AI., Karow, EM., Scheithauer, MO., et al.[2021]

In a study of 127 adults with chronic nasal and sinus symptoms, nasal irrigations using large volumes and low positive pressure significantly improved quality of life, as shown by lower SNOT-20 scores compared to saline sprays over an 8-week period.

At the 8-week mark, only 40% of patients using the irrigation method reported frequent symptoms, compared to 61% in the spray group, indicating that the irrigation method was more effective in reducing symptom frequency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. Pynnonen, MA., Mukerji, SS., Kim, HM., et al.[2015]

In a study involving 211 patients with sinonasal disease, those who used pulsatile hypertonic saline nasal irrigation showed significant improvements in 23 out of 30 nasal symptoms, indicating its efficacy as a treatment.

The use of nasal irrigation also led to better overall health status, as measured by the Quality of Well-Being scale, supporting its role as an effective adjunctive therapy for sinonasal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical study and literature review of nasal irrigation. Tomooka, LT., Murphy, C., Davidson, TM.[2015]

Nasal saline irrigation (NSI) may help reduce symptoms and improve quality of life in children with acute rhinosinusitis (ARS), based on limited evidence from one study, but more research is needed.

There is currently no strong evidence supporting the use of NSI in children with chronic rhinosinusitis (CRS), highlighting the need for more high-quality studies with standardized outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline irrigation in pediatric rhinosinusitis: A systematic review. Gallant, JN., Basem, JI., Turner, JH., et al.[2019]

Saline nasal irrigation is an effective adjunctive therapy for managing symptoms of chronic rhinosinusitis, with consensus guidelines supporting its use for various upper respiratory conditions.

The procedure is considered safe, with no serious adverse events reported, and minor side effects can be minimized through proper technique and salinity adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation for upper respiratory conditions. Rabago, D., Zgierska, A.[2021]

In a study of 30 participants, daily betamethasone nasal irrigation for six weeks significantly improved symptoms of chronic rhinosinusitis, as measured by the Sino-Nasal Outcome Test, with 63% of participants achieving clinically meaningful improvements.

The treatment did not significantly alter morning serum cortisol levels, and while there was a decrease in 24-hour urinary free cortisol, this change was considered clinically negligible, indicating that betamethasone nasal irrigation is a safe option for patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of nasal lavage with betamethasone cream post-endoscopic sinus surgery: clinical trial. Dawson, B., Gutteridge, I., Cervin, A., et al.[2018]

Saline irrigation (SI) is a common treatment for nasal issues, working through mechanisms like clearing mucus, improving mucociliary function, and enhancing the antimicrobial properties of nasal secretions, but its effectiveness is not strongly supported by current evidence.

While SI is generally safe, it can cause side effects such as nasal discomfort and otalgia, and there are concerns about contamination of solutions, highlighting the need for more research, especially in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of nasal saline irrigation in nasal inflammatory diseases]. Tan, L., Xu, Y.[2019]

Nasal saline irrigation (NSI) is a low-risk and beneficial treatment for chronic rhinosinusitis (CRS), helping to thin mucus and improve nasal clearance, but there is no consensus on the optimal delivery method or solution composition due to limited evidence.

Despite its widespread use, NSI has faced scrutiny for potential risks, such as associations with primary amebic meningoencephalitis, highlighting the need for careful hygiene and delivery practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal saline irrigation: a clinical update. Succar, EF., Turner, JH., Chandra, RK.[2020]

Nasal saline irrigation is an effective treatment for symptoms of chronic rhinosinusitis and other sinonasal diseases, with a high-volume, low-pressure squeeze bottle being the best delivery method.

Research suggests that adding xylitol and topical fluconazole may enhance the effectiveness of nasal irrigations, particularly in chronic rhinosinusitis and allergic fungal sinusitis, although further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of nasal irrigations and nebulizations for nasal symptom relief. Dunn, JD., Dion, GR., McMains, KC.[2015]

In a study involving 60 patients over 17 days, a sodium chloride nasal gel at a concentration of 6.0mg/g was found to provide greater comfort and less stinging sensation compared to a 4.5mg/g concentration.

Both concentrations of the nasal gel did not show a significant difference in humidification effectiveness, indicating that while comfort levels varied, the ability to humidify the nasal passages remained consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Ringer's lactate gel formulation on nasal comfort and humidification. Neves, MCD., Romano, FR., Guerra Filho, S.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation: Its role as an adjunct treatment. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical study and literature review of nasal irrigation. [2015]

5. Ireland pubmed.ncbi.nlm.nih.gov

Nasal saline irrigation in pediatric rhinosinusitis: A systematic review. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Saline nasal irrigation for upper respiratory conditions. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The effects of nasal lavage with betamethasone cream post-endoscopic sinus surgery: clinical trial. [2018]

8. China pubmed.ncbi.nlm.nih.gov

[Application of nasal saline irrigation in nasal inflammatory diseases]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Nasal saline irrigation: a clinical update. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of nasal irrigations and nebulizations for nasal symptom relief. [2015]

11. Brazil pubmed.ncbi.nlm.nih.gov

New Ringer's lactate gel formulation on nasal comfort and humidification. [2022]