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Lupus Clinical Trials

New Medical Therapies™

Acute Rhinitis

April 2, 2012

Biota Holdings issued results from a phase II trial of vapendavir for the treatment of naturally acquired human rhinovirus (HRV) infection in asthmatics. This multicenter, randomized, double-blind, placebo controlled study enrolled 300 subjects who received either 400 mg of vapendavir or placebo twice daily for six days. The trial was conducted over two consecutive rhinovirus seasons. The primary efficacy parameter was the mean daily difference in WURSS-21 (Wisconsin Upper Respiratory Symptom Survey-21) severity score over days two through four. Vapendavir treatment resulted in a statistically significant reduction in the severity score of cold symptoms when compared to placebo (p≡0.028). The WURSS scores also showed a statistically significant improvement in mean daily difference through day 14 (p≡0.001). Reduction in the use of asthma reliever medication showed a positive trend toward improvement in the vapendavir group as early as day three of treatment and reached statistical significance on day 13 (p≡0.045). In addition, subjects receiving vapendavir showed a statistically significant lower incidence of virus infection (74.4%) compared to placebo (91.4%) on day three (p≡0.025) and evening peak expiratory flow (PEF) was significantly higher in the vapendavir group on day five (p≡0.023). There were no serious adverse events and generally BTA798 was well tolerated.

May 30, 2011

Actelion issued results from a phase II trial of their CRTH2 receptor antagonist for the treatment of seasonal allergic rhinitis. This double-blind, placebo-controlled, randomized study enrolled 579 subjects with seasonal allergic rhinitis due to mountain cedar pollen. The subjects were treated for two weeks with various doses of the CRTH2 antagonist or placebo. The primary endpoint was to demonstrate efficacy versus placebo on the mean change from baseline in Daytime Nasal Symptom Score over the entire treatment period. The primary endpoint was reached with statistical significance (p<0.05). The treatment was well tolerated across all treatment groups and no serious adverse events were reported.

February 14, 2011

Teva released positive results from a phase III trial of Qnaze, their nasal aerosol corticosteroid for perennial allergic rhinitis. The randomized, double-blind, placebo-controlled, parallel-group clinical study enrolled 470 subjects, aged 12 years and older, who received Qnaze nasal aerosol 320 mcg or placebo once-daily for six weeks. The primary endpoint, the change from baseline in the average morning and evening subject-reported reflective Total Nasal Symptom Score (rTNSS), was reached with statistical significance over placebo (p<0.001). The change in instantaneous TNSS (iTNSS), a secondary endpoint, was also significantly greater versus placebo. In addition, for both of these measures, all four individual nasal symptom scores of runny nose, nasal congestion, nasal itching and sneezing demonstrated significant improvement versus placebo. Qnaze was well tolerated.

October 11, 2010

ISTA Pharmaceuticals reported positive results from a phase I/II trial of bepotastine besilate nasal spray for the treatment of seasonal allergic rhinitis. This double-masked, randomized, placebo-controlled, parallel-group study enrolled 82 subjects in Canada. The subjects were exposed on multiple occasions in an Environmental Exposure Chamber to a high aerosol concentration of a common seasonal allergen to which they were sensitive. They graded their individual symptoms at select time intervals prior to and following a single dose or one week of dosing with one of three bepotastine besilate nasal spray doses or placebo. The highest two concentrations of bepotatine besilate nasal spray tested showed statistically significant improvement compared to placebo in reducing total nasal symptoms. These reports were consistent for both instantaneous and reflective experiences of their total nasal symptoms. Statistically significant improvements also were seen for all individual nasal symptoms, with the most rapid improvement seen for drug-related reductions in sneezing and nasal itching. Adverse events were similar across all treatment groups.

March 23, 2009

Cydex released positive results from a phase II trial of CDX-313 nasal spray for the treatment of seasonal allergic rhinitis (SAR). This randomized, double-blind, three-way cross-over study enrolled 108 subjects with SAR. The subjects received CDX-313 nasal spray (Budesonide + Azelastine), Rhinocort Aqua + Astelin Nasal Spray or placebo nasal spray while in an environmental exposure chamber. Relief of all nasal symptoms as measured by the Total Nasal Symptom Score (TNSS) was significantly greater than placebo from 20 minutes following administration until the session end (10 hours) for both CDX-313 and Rhinocort Aqua/Astelin (p<0.0001). Onset of action of relief from itchy nose and sneezing were significantly faster at 10 minutes for CDX-313 compared to Rhinocort Aqua/Astelin. Relief of all eye symptoms as measured by the Total Ocular Symptom Score (TOSS) was significantly greater than placebo from 40 minutes following administration until the session end (10 hours) for both CDX-313 and Rhinocort Aqua/Astelin (p<0.0001). CDX-313 provided the same or greater numerical TOSS relief than Rhinocort Aqua/Astelin and longer-lasting relief of red/burning eyes and itchy eyes.

May 26, 2008

Allergy Therapeutics released positive results from a phase III trial of Pollinex Quattro for the treatment of seasonal allergic rhino-conjunctivitis caused by grass allergy. This double-blind placebo-controlled study, dubbed G301, enrolled 1,028 subjects in the United States, Canada and Europe. The subjects received four injections of either Pollinex Quattro or placebo treatment over three weeks prior to the 2007 grass pollen season. They then recorded rhino-conjunctivitis symptoms and medication intake over the course of the pollen season from May to September. The primary endpoint was the difference in combined symptom plus medication score between active and placebo treatment over the four peak pollen weeks of the season. The primary endpoint was reached, with a 13.3% improvement in the Pollinex Quattro group over placebo (p = 0.0038) in the Intent To Treat population and a 26.9% improvement over placebo in the prospectively defined patient population (p = 0.0031). Treatment was determined to be safe and well tolerated. Based on the results Allergy Therapeutics plans to file an MAA in the EU in quarter one of 2009.

April 28, 2008

Inspire reported negative results from a phase III trial of epinastine nasal spray for the treatment of seasonal allergic rhinitis (SAR). This fourteen-day, randomized, double-blind trial enrolled seven hundred and ninety eight subjects with documented SAR during mountain cedar season in south central Texas. The subjects received epinastine (0.10% and 0.15%) or placebo. The primary efficacy endpoint was average change from baseline for the reflective Total Nasal Symptom Score (TNSS). The study failed to achieve statistical significance compared to placebo on this endpoint. Based on the results Inspire has decided to discontinue the development of epinastine nasal spray.

August 13, 2007

Cobalis announced additional positive results from a phase III trial of PreHistin for the treatment of seasonal allergic rhinitis. These parallel, randomized, double-blind trials enrolled 1,551 subjects in the US. Subjects received either a placebo or a 3.3-mg sublingual dosage of PreHistin twice daily for three weeks prior to the onset of the ragweed allergy season and for an additional three weeks into the allergy season. Results showed a significant average increase of more than 250% in post-treatment blood serum cobalamin (Vitamin B12) levels across the two PreHistin-treated groups compared with essentially no B12 level increase in placebo-treated groups. In the first trial, the mean pre-treatment B-12 levels (measured as pg/mL) for the PreHistin and placebo groups, respectively, were 554.60 and 521.90 and the mean post-treatment B-12 levels were 2050.50 and 526.50, for a 269.73% versus 0.88% change. In the second trial, the mean pre-treatment B-12 levels for the PreHistin and placebo groups, respectively, were 581.58 and 508.54 and the mean post-treatment B-12 levels were 1938.31 and 514.70, for a 233.28% versus a 1.21% change. Cobalis plans to pursue US regulatory approval.

December 5, 2005

Rigel Pharmaceuticals issued negative results of a phase II study of R112, for the treatment of allergic rhinitis. Trial data failed to meet their primary endpoint, producing no significant reduction in symptom severity score on the total nasal symptom severity diagnostic scale, compared to placebo. Subjects receiving treatment with an approved control drug did experience such a reduction. This randomized, double-blind, controlled study enrolled 396 patients across 25 US sites, who received the drug, approved treatment with beclomethasone, or placebo twice daily for 7 days.

October 31, 2005

Cobalis issued positive final results of a phase III trial of PreHistin, for the treatment of allergic rhinitis. Results from the study demonstrated a statistically significant reduction in symptom severity score for both mean values for weeks 4-6 (p=0.0262) and the week 6 final analysis (p=0.0416), compared to baseline. Efficacy was also demonstrated in comparison to placebo for both values (p=0.0028, p=0.0048, respectively). The magnitude of difference in score, 1.31 points, represented a clinically significant difference. This randomized, double-blind, placebo-controlled, multi-center study enrolled 714 subjects across 8 US sites, who received the drug or placebo for 6 weeks during peak allergy season. These data served to support the company's ongoing phase III development program and eventual NDA submission.

September 26, 2005

Evolutec has issued positive results of a phase II trial of rEV131, their recombinant immunomodulatory drug under investigation for the treatment of seasonal allergic rhinitis. Results from the study met their primary efficacy endpoint, producing a significant reduction in the mean sum of symptom scores at 15 minutes (p<0.05). Symptom relief was seen to be dose-dependent, and no serious adverse events or tolerability concerns were raised. This placebo-controlled, single-dose, dose- ranging allergen-challenge study enrolled 112 patients across 2 sites in San Antonio, Texas, who were randomized into one of four 20-patient single-dose cohorts (16 active, 4 placebo), or a fifth cohort of 32 subjects at the optimum dose (16 active, 16 placebo). Based on these results, the company announced plans to initiate a multiple-dose phase II study of the drug in the near future.

July 11, 2005

Corixa has announced positive results of a phase I trial of CRX-675, their toll-like receptor 4 agonist under investigation for the treatment of allergic rhinitis. Results from the study met their primary safety endpoints, with no serious adverse events reported and an overall positive tolerability profile, which was similar to placebo. Exploratory efficacy data indicated that a 100 mcg dose of the drug yielded trends towards reduction in nasal symptoms following ragweed challenge at both 1 and 14 days. Neither a dose-response relationship nor a trend towards improvement in nasal congestion was not noted. This randomized, blinded, placebo-controlled study enrolled 64 subjects, who were randomized to receive one of 4 single escalating doses of the drug (2 mcg, 20 mcg, 100 mcg or 200 mcg; n=12/group) or placebo (n=16). The company announced plans to initiate safety and efficacy studies by the end of 2005 or early 2006.

June 20, 2005

Naryx Pharma announced positive results of a phase II study of their investigational nebulizable nasal antibiotic SPRC- AB01, for the treatment of chronic rhinosinusitis. Preliminary results from the study met their primary endpoint, with subjects in the high dose cohort achieving a statistically significant reduction in the signs and symptoms of chronic rhinosinusitis at the end of treatment, compared to placebo. Furthermore, the drug was seen to be safe and well tolerated, with overall incidence of adverse events seen to be comparable between both drug dosing cohorts and placebo. This double-blind, placebo-controlled, multi-center study enrolled 58 post-surgical patients with chronic rhinosinusitis, who received either low or high dose SPRC-AB01 or placebo via nebulizer twice daily for 21 days.

February 9, 2004

Intranasal Technology reported results from a clinical trial investigating their intranasal hydromorphone, a narcotic and analgesic for the treatment of allergic rhinitis. Results showed median times to peak plasma concentrations of 10 minutes in the hydromorphone IV group and 15 minutes in the hydromorphone intranasally group. Data showed a statistically significant delay in time to peak in subjects treated with fluticasone propionate. The open-label, randomized, three-way crossover, inpatient study enrolled 12 subjects with perennial or seasonal rhinitis. Subjects were randomized to receive single doses of hydromorphone HCl 2.0 mg intravenously, intranasally with no pretreatment, or intranasally after 6 days of pretreatment with fluticasone propionate. Results were reported in the January issue of Pharmacotherapy.

March 18, 2002

Sepracor reported that it has received a non-approvable letter regarding Soltara (tecastemizole), its investigational treatment for allergic rhinitis. The FDA indicated that safety studies were not conducted over a sufficient duration of time in light of Soltara's extended elimination phase. Concerns raised by the FDA included QTc prolongation and cardiomyopathy. Sepracor plans to meet with the FDA to discuss methods for resolving the issues regarding the NDA.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.