Spray In Patients Research Articles

Meta-analysis of the efficacy of ectoine nasal spray in patients with allergic rhinoconjunctivitis.

Objectives. The meta-analysis aims to investigate the efficacy of ectoine nasal spray and eye drops in the treatment of allergic rhinitis and rhinoconjunctivitis symptoms. Design and Methods. This meta-analysis is based on yet unpublished data of four studies. Both nasal and eye symptoms were documented in patient diary cards. All scales were transformed into a 4-point scale: 0 = no, 1 = mild, 2 = moderate, and 3 = severe symptoms. Each symptom was analysed individually in a meta-analysis of the area under the curve values as well as in a meta-analysis of pre- and posttreatment comparison. Results. After seven days of treatment with ectoine nasal spray both nasal and ocular symptoms decreased significantly. A strong reduction of symptom severity was shown for the parameters rhinorrhoea (31.76% reduction) and nasal obstruction (29.94% reduction). Furthermore, the meta-analyses of individual symptoms to investigate the strength of effect after seven days of medication intake showed significant improvement for nasal obstruction, rhinorrhoea, nasal itching, sneezing, itching of eyes, and redness of eyes. The improvement of the symptom nasal obstruction was associated with a strong effect 0.53 (±0.26). Conclusions. The ectoine nasal spray and eye drops seem to be equally effective as guideline-recommended medication in the treatment of rhinoconjunctivitis symptoms.

Sa1608 Successful Use of Novel Hemostatic Spray in Patients With Active Colonic Bleeding Resistant to Conventional Endoscopic Hemostatic Therapy

Sa1608 Successful Use of Novel Hemostatic Spray in Patients With Active Colonic Bleeding Resistant to Conventional Endoscopic Hemostatic Therapy

ELLIPSE Study

Background: Hereditary hemorrhagic telangiectasia (HHT) is a dominantly inherited genetic vascular disorder in which epistaxis is the most frequent manifestation, responsible for high morbidity. Management of this symptom has no standard, and local treatments are often aggressive. Their efficacy is variable and has not been proven. Anti-angiogenic drugs, such as bevacizumab, are a new treatment strategy. Its systemic administration in patients with HHT improves liver damage-related symptoms and epistaxis. To limit the systemic adverse effects of bevacizumab and to ease administration, a local administration seems suitable. Primary objective: To evaluate the tolerance of increasing doses of bevacizumab administered as a nasal spray in patients with HHT-related epistaxis. Secondary objectives were to study the bioavailability and efficacy of bevacizumab against epistaxis when given as a nasal spray. Methodology: Phase 1, randomized, double-blind, placebo-controlled, monocentric study performed sequentially (dose escalation) on 5 groups of 8 patients. Each group was made up of 6 verum and 2 placebos. Five increasing doses of bevacizumab nasal spray (25 mg/mL) were evaluated: 12.5, 25, 50, 75 and 100 mg. Results: A total of 40 patients were included between October 2011 and October 2012. Bevacizumab nasal spray was well tolerated in all patients and the drug was not detected in their serum. No dose limiting toxicity was observed. No efficacy was observed at any dose in this study. Conclusion: Based on these results, bevacizumab nasal spray is a safe treatment of epistaxis in HHT. However, a randomized Phase 2 study is needed to determine its efficacy. Trial Registration: ClinicalTrials.gov Identifier #NCT01507480

Clinical experience with THC:CBD oromucosal spray in patients with multiple sclerosis-related spasticity

This detailed medical charts’ data collection study conducted at a multiple sclerosis (MS) clinic in Germany evaluated the effectiveness of tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray in patients with resistant MS spasticity. Over a 15-month timeframe, THC:CBD spray was initiated in 166 patients. Mean follow-up was 9 months. In all, 120 patients remained on treatment for a response rate of 72%. THC:CBD spray was used as add-on therapy in 95 patients and as monotherapy in 25 patients to achieve best-possible therapeutic results. Among responders, the mean spasticity 0–10 numerical rating scale (NRS) score decreased by 57%, from 7.0 before treatment to 3.0 within 10 days of starting THC:CBD spray. The mean dosage was 4 sprays/day. Most patients who withdrew from treatment (40/46) had been receiving THC:CBD spray for less than 60 days. Main reasons for treatment discontinuation were: adverse drug reactions, mainly dizziness, fatigue and oral discomfort (23 patients; 13.9%); lack of efficacy (14 patients; 8.4%); or need for a baclofen pump (9 patients; 5.4%). No new safety signals were noted with THC:CBD spray during the evaluation period. In this routine clinical practice setting at an MS clinic in Germany, THC:CBD spray was effective and well tolerated as add-on therapy or as monotherapy in a relevant proportion of patients with resistant MS spasticity.

A patient preference and satisfaction study of ciclesonide nasal aerosol and mometasone furoate aqueous nasal spray in patients with perennial allergic rhinitis

Patients' preference and satisfaction with their nasal allergy medications may be influenced by their sensory attributes. This study evaluates patient preference and satisfaction with ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) compared with mometasone furoate aqueous nasal spray (MFNS). Symptomatic subjects with perennial allergic rhinitis (PAR) were randomized to CIC-HFA at 74 micrograms or MFNS at 200 micrograms q.d. in an open-label, two-period, crossover study. Subject preference was recorded as total preference score (TPS; average of 17 individual preference items) at the end of treatment period 2, and satisfaction was assessed with a 76-item, self-administered instrument at baseline and at the end of each 2-week treatment period. The primary assessments were TPS and regimen attributes composite satisfaction score composed of two of nine satisfaction subscales: sensory impact (including medication running out of the nose, medication running down the throat, and impact on smell and taste) and regimen management (comprised of issues relating to dosing and ability to remember to take medication). Two hundred ninety-four subjects completed the study. A total of 68.1% of subjects preferred CIC-HFA (p < 0.0001 versus MFNS), with a mean TPS of 68.3 versus 31.7 for the MFNS group. The regimen attributes composite satisfaction score significantly (p < 0.0001 for each treatment period) favored CIC-HFA versus MFNS at the end of treatment period 1 (85.5 vs 77.6) and treatment period 2 (83.0 versus 73.5), respectively. In this study, subjects reported higher preference for and satisfaction with CIC-HFA compared with MFNS, suggesting significant differences in patient perception of attributes in favor of CIC-HFA. Clinical trial registration URL and registration number: www.clinicaltrials.gov/ct2/show/NCT01401465.

Efficacy of a Carrageenan nasal spray in patients with common cold: a randomized controlled trial

BackgroundThe common cold is the most widespread viral infection in humans. Iota-carrageenan has previously shown antiviral effectiveness against cold viruses in clinical trials. This study investigated the efficacy of a carrageenan-containing nasal spray on the duration of the common cold and nasal fluid viral load in adult patients.MethodsIn a randomized, double-blind, placebo-controlled trial, 211 patients suffering from early symptoms of the common cold were treated for seven days. Application was performed three times daily with either a carrageenan-supplemented nasal spray or saline solution as placebo with an overall observation period of 21 days. The primary endpoint was the duration of disease defined as the time until the last day with symptoms followed by all other days in the study period without symptoms. During the study, but prior unblinding, the definition of disease duration was adapted from the original protocol that defines disease duration as the time period of symptoms followed by 48 hours without symptoms.ResultsIn patients showing a laboratory-confirmed cold virus infection and adherence to the protocol, alleviation of symptoms was 2.1 days faster in the carrageenan group in comparison to placebo (p = 0.037). The primary endpoint that had been prespecified but was changed before unblinding was not met. Viral titers in nasal fluids showed a significantly greater decrease in carrageenan patients in the intention-to-treat population (p = 0.024) and in the per protocol population (p = 0.018) between days 1 and 3/4.ConclusionsIn adults with common cold virus infections, direct local administration of carrageenan with nasal sprays reduced the duration of cold symptoms. A significant reduction of viral load in the nasal wash fluids of patients confirmed similar findings from earlier trials in children and adults.Trial registrationCurrent Controlled Trials ISRCTN80148028

A Report on the Long-Term Use of Fentanyl Pectin Nasal Spray in Patients With Recurrent Breakthrough Pain

ContextAs patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use. ObjectivesTo investigate the long-term use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients receiving regular opioid therapy. MethodsAdult patients (N = 401) taking at least 60 mg/day oral morphine or equivalent, experiencing one to four episodes of BTPc a day, entered an open-label long-term study (NCT00458510). Patients had either completed an FPNS randomized controlled trial or were newly identified. Of these, 171 patients continued into an extension study. Up to four episodes of BTPc a day were treated with FPNS at 100–800 μg titrated doses. During the extension study, patients visited the clinic every four weeks for assessment and reporting of adverse events (AEs). ResultsThere were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for ≥360 days; the maximum duration was 44 months. Seventy percent of patients did not change their FPNS dose; 2% of patients withdrew from the study because of the lack of efficacy. The most common AEs, aside from disease progression, were insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of FPNS-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced nasal AEs, most of which were mild or moderate. ConclusionFPNS appeared to provide sustained benefit and was well tolerated during long-term treatment of BTPc.

Long-term use of fentanyl pectin nasal spray in patients with breakthrough pain in cancer.

9563 Background: Given that patients with cancer are living longer, there is a need to ensure that treatments used for palliative care are well tolerated and effective during long-term use. The objective of this study was to investigate the use of fentanyl pectin nasal spray (FPNS) for the treatment of breakthrough pain in cancer (BTPc) in patients taking regular opioid therapy. Methods: A total of 401 adult patients, taking at least 60 mg/day oral morphine or equivalent, with an average of 1 to 4 episodes of BTPc per day, who were either newly enrolled or had completed a randomized controlled trial with FPNS, entered into an open-label assessment study (NCT00458510). Of these, 171 patients, continued into an extension period. Up to 4 episodes of BTPc per day were treated with FPNS at titrated doses between 100 µg and 800 µg. Patients returned to the clinic at 4-week intervals for assessment and reporting of any adverse events (AEs). Results: There were 163 patients with documented FPNS use. The mean duration of use was 325 days; 46 patients used FPNS for more than 1 year, while the maximum duration was 3 years and 8 months. In total, 2% of patients withdrew from the study due to lack of efficacy. Seventy-four percent of patients did not change their FPNS dose. The most common AEs, aside from disease progression, were: insomnia, 9.9%; nausea, 9.4%; vomiting, 9.4%; and peripheral edema, 9.4%. The overall incidence of treatment-related AEs was 11.1%, the most common being constipation (4.1%), with no apparent dose relationship. Ten patients (5.8%) experienced treatment-related nasal AEs, which, with the exception of 1 severe event, were all mild or moderate. Conclusions: FPNS appeared to provide a sustained benefit and was well tolerated during the long-term treatment of BTPc. Clinical trial information: NCT00458510.

Ocular safety of fluticasone furoate nasal spray in patients with perennial allergic rhinitis: a 2-year study

BackgroundThis is the first study, to our knowledge, to evaluate the ocular effects of an intranasal corticosteroid during 2 years of treatment for perennial allergic rhinitis (PAR). ObjectiveTo assess ocular safety in adult and adolescent patients 12 years and older with PAR after 2 years of continuous treatment with fluticasone furoate nasal spray (FFNS), 110 μg once daily, and placebo. MethodsThis was a 2-year, randomized, double-blind, placebo-controlled study of once-daily FFNS, 110 ìg, and placebo in 548 patients 12 years and older with PAR. The primary ocular safety end points were time to first occurrence of an event for the Lens Opacities Classification System, Version III (LOCS III), posterior subcapsular opacity (PSO) and time to first occurrence of an event for intraocular pressure (IOP). ResultsOn the basis of survival analyses, the difference between the treatment groups for time to first occurrence of a LOCS III PSO and time to first occurrence of an IOP event was not statistically significant (P = .39 and P = .34, respectively). Changes from baseline in visual acuity, LOCS III PSO, cortical opacity, LOCS III nuclear opacity and nuclear color, IOP, and horizontal cup-to-disc similar between treatment groups. There were no ophthalmic-related adverse events of LOCS III PSO or IOP that led to early withdrawal. The most common drug-related adverse event was epistaxis (FFNS, 28%; placebo, 14%). ConclusionThese data neither support nor negate current recommendations for regular ophthalmic monitoring in patients treated with intranasal corticosteroids. Trial Registrationclinicaltrials.gov Identifier: NCT00682643.

A Prospective Study: Clinical Significance of Anticholinergic Nasal Sprays in Patients with Parkinson Disease Afflicted by Rhinorrhea (P04.149)

A Prospective Study: Clinical Significance of Anticholinergic Nasal Sprays in Patients with Parkinson Disease Afflicted by Rhinorrhea (P04.149)

Tolerability and effects on quality of life of liposomal nasal spray treatment compared to nasal ointment containing dexpanthenol or isotonic NaCl spray in patients with rhinitis sicca

This study aimed to investigate symptom reduction via the liposomal nasal spray LipoNasal (LN) in patients with rhinitis sicca. Tolerability and the impact on quality of life were also examined. The same parameters were established in parallel for treatment approaches with Bepanthen (BP) nasal ointment containing dexpanthenol and the Rhinomer (RH) nasal spray containing NaCl. This prospective, controlled, open-label observation study was a multicenter trial. 92 patients with rhinitis sicca were allocated to three arms according to their symptoms: LN: n = 33; BP: n = 32 and RH: n = 27. The study comprised three visits at an interval of 14 days. Efficacy was examined by the Rhinitis Sicca Symptom Score (RSSS) documented daily and at the visits based on an endoscopic evaluation. The nasal spray sensory scale was used to investigate the tolerability. Quality of life (QoL) was measured by means of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and the “Short Form 12” of the “Impact on Health-Related Quality of Life (HRQL)” questionnaire on general quality of life. Nasal symptoms improved significantly (p = 0.001) under all three treatment approaches, reflected by the reduction in the RSSS and the Endoscopy Sum Score. A comparison of the three groups showed that no therapy was significantly superior to any of the others (p = 0.410). The tolerability of all treatments was good. Concerning the nasal moisturization, LipoNasal was evaluated better than Bepanthen and Rhinomer. Quality of life improved in all groups, but not significantly. The results show good efficacy and tolerability of the liposomal nasal spray compared to generally recognized treatments of rhinitis sicca with dexpanthenol nasal ointment and NaCl nasal spray. LipoNasal therefore constitutes a good treatment for patients suffering from dry nose.

Lidocaine lozenge versus lidocaine spray as topical anesthesia before direct awake laryngoscopy: A randomized active controlled trial

Context: Key to successful awake direct laryngoscopy is establishing reliable local anesthesia. Lidocaine spray was reported to be effective in laryngoscopic procedure with less hemodynamic and cardiovascular disturbances. Novel formulation of lidocaine as lozenges was developed to avoid problems of throat irritation and bitter taste associated with spray. Aims: The aim of the following study is to compare the efficacy and safety of lidocaine lozenges versus lidocaine spray in patients undergoing awake diagnostic direct laryngoscopy. Design: A prospective, randomized, open label, active controlled, multicentric study. Subjects and Methods: Patients of either sex, aged between 18 to 80 years and undergoing awake diagnostic direct laryngoscopy were enrolled after screening for eligibility criteria. Enrolled patients were randomized to one of the two treatment; lidocaine lozenges 200 mg and lidocaine spray 200 mg to be applied as a single dose before laryngoscopy. Immediately after the procedure, efficacy, and safety was assessed. Statistical Analysis: Between groups comparison was done using appropriate parametric or nonparametric tests. Results: Investigator experienced significantly lesser procedural difficulty and reduced gag reflex during the procedure with lidocaine lozenges compared to spray. Lesser number of patients experienced aversive symptoms (especially nausea, vomiting, cough, and pain) during and after the procedure and significantly more number of patients preferred to have a repeat procedure with lidocaine lozenges compared to spray. The global assessments by the patient and investigator favored lidocaine lozenges over spray. Conclusion: Lidocaine lozenges given before direct awake laryngoscopy provide a significant benefit by offering a more effective, safe, and convenient anesthesia compared to spray.

A phase III trial evaluating the efficacy and tolerability of nimesulide 1% spray in patients with soft-tissue injuries

Aim:To evaluate the efficacy and safety of nimesulide 1% w/w spray in minor soft-tissue injuries in adult Indians through a multicentric, open-labeled, phase III trial.Materials and Methods:125 eligible patients, who met the selection criteria and gave written informed consent, were screened, enrolled, and treated with nimesulide 1% spray for seven days. Patients were assessed at baseline, day 1, day 4, and day 8 for efficacy and safety. Primary efficacy variable pain intensity, was measured using a NRS 1-100 mm (numerical rating scale). Secondary efficacy variables were degree of inflammation and edema and degree of functional impairment; overall assessment of efficacy was done by patient (patient global assessment – PGA) and by investigator (investigator global assessment – IGA) on days 4 and 8.Result:There was a statistically significant reduction in the NRS score, degree of pain, edema (inflammation), and improvement in functional impairment on days 4 and 8 and in serum creatine kinase levels on day 8 in comparison with baseline. Global assessment of efficacy on day 8 was rated as “very good (21%),” “good (67.70%),” and “fair (11.30%)” by investigators and “very good (25%),” “good (58.90%),” and “fair (16.1%)” by patients. Two mild adverse events were reported in two patients, which resolved without any intervention. One (local irritation) was reported as not related, while the other (itching sensation) was probably related to the study drug.Conclusion:Nimesulide 1% spray was effective with a good safety profile and can be considered is a good alternative to oral analgesic therapy in minor soft-tissue injuries.

An Open-Label Extension Study to Investigate the Long-Term Safety and Tolerability of THC/CBD Oromucosal Spray and Oromucosal THC Spray in Patients With Terminal Cancer-Related Pain Refractory to Strong Opioid Analgesics

ContextChronic pain in patients with advanced cancer poses a serious clinical challenge. The Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (U.S. Adopted Name, nabiximols; Sativex®) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group. ObjectivesThis follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer. MethodsIn total, 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing, who had participated in a previous three-arm (THC/CBD spray, THC spray, or placebo), two-week parent randomized controlled trial, entered this open-label, multicenter, follow-up study. Patients self-titrated THC/CBD spray (n=39) or THC spray (n=4) to symptom relief or maximum dose and were regularly reviewed for safety, tolerability, and evidence of clinical benefit. ResultsThe efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for “pain severity” and “worst pain” domains showed a decrease (i.e., improvement) at each visit in the THC/CBD spray patients. Similarly, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 scores showed a decrease (i.e., improvement) from baseline in the domains of insomnia, pain, and fatigue. No new safety concerns associated with the extended use of THC/CBD spray arose from this study. ConclusionThis study showed that the long-term use of THC/CBD spray was generally well tolerated, with no evidence of a loss of effect for the relief of cancer-related pain with long-term use. Furthermore, patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time, suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit.

Associations Between Improvements in Lower Urinary Tract Symptoms and Sleep Disturbance Over Time in the CAMUS Trial

We recently reported an association between the bother and severity of lower urinary tract symptoms secondary to benign prostatic hyperplasia and the severity of sleep disturbance. However, few studies have examined whether alterations in the severity of urinary symptoms influence the degree of sleep problems over time. The severity of lower urinary tract symptoms in men enrolled in CAMUS (Complementary and Alternative Medicine for Urological Symptoms), a clinical trial of saw palmetto (Serenoa repens), was evaluated using AUASI (American Urological Association symptom index) and quality of life scores. Sleep disturbance was evaluated by the Jenkins sleep scale at 0, 24, 48 and 72 weeks. Statistical analyses were used to assess the relationship(s) between changes in lower urinary tract symptoms and sleep disturbance. The baseline characteristics of the 339 men (172 placebo arm and 167 saw palmetto arm) enrolled in the CAMUS trial with assessment of sleep disturbance and urinary symptoms were similar. There were no differences between improvements in the severity of sleep disturbance or urinary symptoms between the 2 experimental arms. Combined analyses of the entire cohort revealed significant associations (p <0.001) between the AUASI score and sleep disturbance severity with time. Multivariate analyses demonstrated that improvements in lower urinary tract symptoms other than nocturia were the most significant predictors of improvements in sleep disturbance. Specific analyses adjusting for other baseline characteristics demonstrated that a 3-point improvement in AUASI score was associated with a 0.73-point improvement in the Jenkins sleep scale with time. Improvements in lower urinary tract symptoms correlate with changes in sleeping abilities with time in men with benign prostatic hyperplasia. While nocturia is significantly associated with sleep disturbance, other changes in overall lower urinary tract symptoms are better predictors of changes in sleep dysfunction.

The Use of Cyanoacrylate Spray in Difficult to Treat Acute Gastrointestinal Bleeding

Purpose: Although endoscopic therapy is highly effective in control of acute gastrointestinal bleeding (GIB), a small portion of patients who fail to achieve hemostasis may require interventional radiologic procedures or surgery with increased morbidity. Cyanoacrylate compound is a tissue adhesive used as a hemostatic agent for treatment of gastric varices and intraoperative bleeding, but data on spray application in acute GIB is limited. The aim of this study is to evaluate the efficacy and safety of cyanoacrylate spray in patients with difficult to treat acute GIB. Methods: Consecutive patients from July 2010 to May 2012 hospitalized at Riverside County Regional Medical Center and Loma Linda University Medical Center who required cyanoacrylate compound spray for treatment of GIB were identified from an internal endoscopic database. Cyanoacrylate spray technique was used after failure of conventional endoscopic treatments per discretion of the endoscopist. Using a 23 gauge sclerotherapy needle positioned 1 cm outside the tip of the endoscope, 0.5-4.0 ml of commercially available cyanoacrylate compound (butyl-2-cyanoacrylate) was sprayed over the bleeding site followed by a rapid normal saline flush to prevent congealing. Results: During the study period, four patients required cyanoacrylate spray for difficult to treat acute GIB (Table). Patient 1 presented with hematochezia and hemodynamic instability requiring 16 units of PRBC. Upper endoscopy showed active arterial bleeding from a duodenal ulcer base, despite blind epinephrine injection. Half ml of cyanoacrylate spray achieved hemostasis. However, due to limited experience with this technique, the patient underwent IR embolization despite lack of rebleeding. Patient 2 with history of Osler-Webber-Rendu Syndrome presented with melena due to multiple gastric vascular ectasias. One ml of cyanoacrylate spray achieved hemostasis. The patient had rebleeding after 18 days possibly from a different gastric vascular ectasia. Patient 3 on aspirin presented with hematochezia and hemodynamic instability after polypectomy. Half ml of cyanoacrylate spray achieved hemostasis. Patient 4 presented with melena and hemodynamic instability from a duodenal ulcer with arterial spurting requiring 8 units of PRBC. Four ml of cyanoacrylate spray achieved hemostasis. Repeat EGD next day revealed no active bleeding. No immediate or delayed complications were noted on the four patients at a median follow-up of 42 days (range, 28-120).Table: [1773]Conclusion: In patients with active GIB that is difficult to control with conventional endoscopic modalities, cyanoacrylate spray achieved 100% hemostasis. This novel technique is simple, safe, and efficacious and should be considered in the armamentarium in the treatment of GIB.

PWE-121 Does chromoendoscopy allow avoidance of duodenal biopsy in coeliac disease?

IntroductionChromoendoscopy is increasingly being used to detect, localise and characterise mucosal abnormalities seen at gastrointestinal endoscopy. The endoscopic features of coeliac disease may be difficult to recognise and are reported...

Effective dose titration of fentanyl sublingual spray in patients with breakthrough cancer pain: results from the open-label phase of a double-blind, placebo-controlled study

Breakthrough cancer pain (BTCP) is commonly managed with formulations of transmucosal fentanyl. A novel sublingual formulation of fentanyl, fentanyl sublingual spray, has been developed to enhance the rate and extent of fentanyl absorption and potentially the onset of analgesia. This analysis presents results from the 26-day open-label titration phase of a phase 3, randomized, double-blind, placebo-controlled study. Opioid-tolerant patients with 1-4 episodes of BTCP/d were enrolled. For randomization into double-blind treatment, patients must have successfully titrated to a dose (100-1600 mcg) that provided effective analgesia for 2 consecutive BTCP episodes. The Treatment Satisfaction Questionnaire for Medication was assessed at screening to determine satisfaction with previous BTCP medication and at the end of titration to determine satisfaction with fentanyl sublingual spray. Of 130 patients undergoing titration, 98 (75%) achieved a successful dose; the median dose was 800 mcg, and the most common doses were 800 mcg (22.4%) and 1200 mcg (20.4%). Of 32 (25%) patients that withdrew from titration, only 3 (2.3%) were unable to establish an effective dose. At the end of titration, 89% were satisfied, very satisfied, or extremely satisfied with fentanyl sublingual spray, compared with 41% with their previous BTCP medication. Notably, 90% were at least satisfied with the onset of effect of fentanyl sublingual spray versus 21% in relation to previous BTCP treatment. Seventy-eight patients (60%) reported ≥1 adverse event (AE). Thirty-three AEs (25.4%) were considered probably related to treatment, the most common being nausea (6.2%) and somnolence (4.6%). These data demonstrate that in patients with BTCP, fentanyl sublingual spray can be safely titrated to an effective dose, and many prefer this treatment over previous BTCP medications. Technical editorial and medical writing assistance provided by Synchrony Medical, LLC, West Chester, PA, funded by INSYS Therapeutics, Phoenix, AZ.

Advances in upper airway diseases and allergen immunotherapy in 2011

The purpose of this review is to highlight recently published important articles on upper airway diseases and allergen immunotherapy. We review articles on rhinitis, sinusitis, conjunctivitis, and immunotherapy. New insights into epidemiology, pathophysiology, diagnosis, and therapy are described for each of the above diseases.

Efficacy and safety of azelastine 0.15% nasal spray administered once daily in patients with allergy to Texas mountain cedar pollen

A previous study with azelastine nasal spray in patients with seasonal allergic rhinitis (SAR) demonstrated that increasing the azelastine concentration from 0.1% to 0.15% allowed for once-daily dosing without increasing the incidence of adverse effects. This study evaluated the efficacy of azelastine 0.15% nasal spray administered once daily for treating symptoms of SAR. In this 14-day, randomized, double-blind, placebo-controlled study, patients with moderate-to-severe SAR were randomized to azelastine 0.15% (n = 251) or placebo (n = 255), both at a dosage of 2 sprays/nostril once daily. The primary efficacy variable was change from baseline in the 12-hour reflective Total Nasal Symptom Score (TNSS). Key secondary variables were change from baseline in 24-hour instantaneous TNSS, to establish the dosing interval, and change from baseline in the Total Ocular Symptom Score (TOSS). The mean improvement (3.57) and percentage improvement (19.3%) in 12-hour reflective TNSS was significant (p < 0.012) with azelastine 0.15% compared to placebo (2.14 and 11.4%, respectively). The mean improvement in 24-hour instantaneous TNSS was also significant (p < 0.001) for azelastine 0.15% compared to placebo, indicating efficacy with once-daily dosing. The overall improvement and percentage improvement in TOSS was significant (p ≤ 0.012) with azelastine 0.15% (2.21 and 16.7%, respectively) compared to placebo (1.28 and 6.0%, respectively). The overall score for the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was significantly (p < 0.001) improved from baseline in the azelastine group compared with the placebo group. Nasal discomfort (3.6%) and bitter taste (2.4%) were the most common adverse events. There were no reports of somnolence with azelastine. Azelastine 0.15% was effective and well tolerated with once-daily dosing. Azelastine 0.15% nasal spray significantly improved a complex of eye symptoms compared to placebo.