The ESS procedure had to be successfully completed without complication on both sides. Steroid-eluting stent were implanted in one side of ethmoid sinus and frontal sinus randomly.

The ESS procedure had to be successfully completed without complication on both sides. The side without the stent is defined as the control side.

Patients

Sinusitis

Nasal Polyps

After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus.

Steroid-eluting stent implant

After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus. And the side without the stent is defined as the control side.

Without Steroid-eluting stent implant

Beijing Tongren Hospital

The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

The Effects of Steroid-eluting Stent Implant for the Treatment of Patients Undergoing Sinus Surgery for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

We used the Lund-Kennedy endoscopic scoring system to measure the patient's nasal cavity based on fi there were edema, vesicles, adhesions, scars and polyps.

Nasal symptoms measured by Visual analog score. The four nasal symptoms (nasal obstruction, rhinorrhea, headache and olfactory disorder) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a10-point scale (0 = no symptoms;10 = most severe symptoms).

Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³) and Rhinomanometer was used to measure the total nasal airway resistance (Pa·cm⁻³·s⁻1) .

Measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s.

The change of inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of inflammatory cytokines (pg/g) were analysed using the Luminex System.

We obtained nasal mucosa and performed pathological observations to observe changes in the level of inflammatory and changes in the number and quantity of inflammatory cells.

Using CT scanning, we observed changes in the Lund-Mackey scores of bilateral nasal sinuses .

We validate the safety of stent implantation by examining serum cortisol.

During the progress of the experiment, we pay attention to the findings of patients with or without severe reactions.

First Affiliated Hospital, Sun Yat-Sen University

China-Japan Union Hospital, Jilin University

Sleep Apnea

Rhinosinusitis Chronic

The investigational drug is dupilumab, 300mg in 2ml solution for subcutaneous application. All Patients will receive dupilumab, 300mg, every two weeks (8 subcutaneous injections total).

Dupilumab

Brigham and Women's Hospital

Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

Effect of Dupilumab on Sleep Apnea Severity in Patients With Chronic Rhinosinusitis

The effect of dupilumab on OSA severity in patients with nasal obstruction due to chronic rhinosinusitis with or without nasal polyposis (Bilateral CRS). AHI is the amount of respiratory events that a patient has per hours of sleep.

Sleep architecture variables as measured with in-laboratory sleep study of total sleep time

Sleep architecture variables as measured with in-laboratory sleep study of sleep stage percentages

Sleep architecture variables as measured with in-laboratory sleep study of arousal index. The arousal index is how many times a subject wakes up per hour during sleep.

Sleep architecture variables as measured with in-laboratory sleep study of oxygen saturation

Epworth Sleepiness Score (ESS) - The ESS asks the respondent to rate on a 4-point scale (0-3) their usual chances of having dozed off or fallen asleep while engaged in eight different activities that differ widely in their somnificity. The total ESS score (the sum of 8 item-scores) gives an estimate of a more general characteristic, the person's 'average sleep propensity' or ASP, across a wide range of activities in their daily lives. Scores range from 0 to 24, 0 being not sleepy at all and 24 being the most sleepy.

Pittsburgh Sleep Quality Index (PSQI) - The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of "5" or greater is indicative of poor sleep quality. If you scored "5" or more it is suggested that you discuss your sleep habits with a healthcare provider. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. A higher score indicates that a person generally has difficulty carrying out certain activities because you are too sleepy or tired.

Functional Outcomes of Sleep Quality (FOSQ) - Disease specific quality of life questionnaire to determine functional status in adults; measures are designed to assess the impact of disorders of excessive sleepiness on multiple activities of everyday living and the extent to which these abilities are improved by effective treatment. This scale has 30 items, 5 factor subscales, scaling of items is 0-4. To obtain total score, take all the subscale scores and calculate the mean of these scores and then multiply that mean by five. The potential range of scores for the total score is 5-20.

Subjective sleep quality [visual analog scale(VAS)] - on a scale of 1-10, subjects answer questions on how sleepy they are with 0 being least sleepy and 10 being most sleepy

Effect of 16 weeks of dupilumab on awake nasal resistance measurements using a pressure catheter

Effect of 16 weeks of dupilumab on awake nasal resistance measurements using a mask with pneumotach

Effect of 16 weeks of dupilumab on the 22 item Sino-Nasal Outcome Test (SNOT-22)

Effect of 16 weeks of dupilumab on the Visual analog scale (VAS) for rhinosinusitis. - on a scale of 1-10, subjects answer questions on their rhinosinusitis symptom with 0 being least severe and 10 being most severe

Effect of 16 weeks of dupilumab on smell identification, using the University of Pennsylvania Smell Identification Test (UPSIT)

Effect of 16 weeks of dupilumab on peak nasal inspiratory flow (PNIF)

Tanya Laidlaw, MD

Director of Translational Research in Allergy

The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily.
Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.

Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily.

The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days..
Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.
Budesonide: Participants will undergo 30-day treatment course that includes budesonide powder added to saline rinse.

Budesonide

Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily for 30 days.
Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse.

Saline Alone

Total

Sex: Female, Male

Race/Ethnicity, Customized

ACE-27 measures the overall severity of comorbid ailments based on the degree of organ de-compensation (none, mild, moderate, or severe). The validated ACE-27 instrument lists various individual comorbid ailments and allows for the identification of degree of organ de-compensation for each ailment. Using a validated scoring method, the overall score of ACE-27 categorizes participants into 4 categories (0=None, 1=Mild, 2=Moderate, or 3=Severe) with category 0 presenting healthy participants with no comorbidities, and category 3 presenting the very sick participants.

Overall Comorbidity (ACE-27)

Polyps

History of sinus surgery

The findings from the endoscopic examination will be collected using the grading system proposed by Lund and Kennedy.(Lund and Kennedy 1997). The LK Endoskopy grading system consits of five terms: Polyposis, discharge, edema, scarring, and crusting. Each of the five terms is graded on an ordinal scale ranging from 0 to 2, and are evaluated for each side of the nose. The Baseline Endoscopic Score is the sum of the scores (ranging from 0-20) with the higher scores indication worse disease.

Baseline Endoscopic Score

The SNOT-22 instrument includes a list of 22 symptoms and social/emotional consequences of rhinosinusitis. Each item is scored on a likert scale ranging from 0-5, with 0 being the best option (not a problem). The total score is calculated as the sum of individual items' responses and can range on a scale from 0-110, with higher scores reflecting worse physical problems, functional, limitations, and emotional characteristics due to chronic rhinosinusitis.

Baseline SNOT-22 Total

The change in Sino-Nasal Outcome test (SNOT-22) scores between baseline and four weeks will serve as the primary outcome measure in this study and will be calculated as:
Primary Outcome Measure, ∆SNOT-22 = SNOT-22 baseline — SNOT-22 4-week follow-up.
The change in SNOT-22 score is measured on a scale from -110 to 110 with positive scores showing improvement with treatment and negative scores showing worse condition after treatment.

Change in SNOT-22 (Sino-Nasal Outcome Test)

The overall response to treatment will be measured with a modification of the Clinical Global Impression of change (CGI) scale. Upon completion of the study, subjects will be asked to answer the following question: "Overall, how would you rate your response to treatment?" Response options are: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. Higher scores mean worse response to treatment.

Clinical Global Impression of Change (CGI)

The change in Endoscopic Scores will be defined as the difference in the Lund-Kennedy Endoscopic score at baseline minus the Lund-Kennedy Endoscopic Score at 4 weeks and will be measured as the difference in scores on a scale that ranges from 0 to 20. Larger positive change reflects better response to treatment.

Change in Endoscopic Scores

Overall Study

Dr. Jay F. Piccirillo, Principal Investigator

Rhinosinusitis

Chronic Eosinophilic Rhinosinusitis

Allergic Rhinosinusitis

Participants will undergo 4-week treatment course that includes budesonide powder added to saline rinse.

Participants will undergo 4-week treatment course that includes lactose (placebo) powder added to saline rinse.

Saline alone

Washington University School of Medicine

The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

Subjects randomized to the LHB position will be instructed to lay supine on the clinical table, with their head hanging over the edge of the bed as far as possible without discomfort. Subjects will be instructed to administer budesonide 1mg/2cc nebules daily for 12 weeks using the MAD syringe, in the head position to which they were randomized.

Subjects randomized to the HDF position will be instructed to kneel down, placing the top of their head on the ground and forehead close to the knees with the nostrils facing upwards. Subjects will be instructed to administer budesonide 1mg/2cc nebules daily for 12 weeks using the MAD syringe, in the head position to which they were randomized.

Subjects randomized to the LHB position will be instructed to lay supine on the clinical table, with their head hanging over the edge of the bed as far as possible without discomfort.

Lying Head Back Position

Subjects randomized to the HDF position will be instructed to kneel down, placing the top of their head on the ground and forehead close to the knees with the nostrils facing upwards.

Head Down and Forward Position

St. Paul's Hospital Sinus Centre

The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device

The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device: A Randomized, Single-blind, Parallel Trial Comparing the Lying-Head-Back Versus the Head-Down-to-Floor Positions

The primary objective of this clinical trial is to compare endoscopic sinonasal mucosal inflammation between patients oriented in the LHB and HDF position after 6 and 12 weeks of treatment. Subject sinus cavities will be assessed by a validated endoscopic mucosal staging system first at baseline, then at 6 weeks and 12 weeks of treatment. Total scores will be compared between the treatment groups. The Lund-Kennedy (LKES) and Philpott-Javer (PJES) endoscopic staging systems will be utilized to quantify the severity of sinonasal disease. The Principal Investigator will complete all endoscopic evaluations and will be blind to treatment allocation.

Sino-Nasal Outcome Test (SNOT-22) is current standard in Rhinology for the assessment of the patient's subjective sinus symptoms and its effect on their daily functioning. Using the SNOT-22, patient quality of life will be assessed at the baseline, 6 weeks, and 12 weeks clinic visit. SNOT-22 change in score between patients in the LHB vs HDF group will be compared between baseline and after 12 weeks of treatment.

nasal polyps/ödem

The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Effect of Dupilumab on Sleep Apnea in Patients With Rhinosinusitis

The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device

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