Ongoing clinical trials

[Guest guest]

Speaking of clinical trials, here are a few that may be of interest :- Montelukast + high-dose fish oil effect on patients with asthma (Indiana U),- high-dose fish oil alone on patients with excessive leukotriene production (UC ),- anti-IgE (Xolair) on AERD, before aspirin desens (Cleveland Clinic),- anti-IgE (Xolair) on AERD+allergy (Scripps Clinic, Dr. son).A few comments :- apparently, researchers have caught on the idea to investigate the effects of Omega3s on asthma and AERDs, which is good news ;- the fish oil trials use high doses (about 4g/day), but on the short-term only ; if you ever take such Omega3 doses on the long-term, adding (natural) Vitamin E might be a good idea to prevent excessive lipid peroxydation ;- excessive leukotriene production is a hallmark of AERDs, so the second trial looks like it was designed with AERDs in mind, but then why did UC restrict recruiting to patients with mutations on the 5-lipoxygenase enzyme only, instead of recruiting all patients with arachidonic acid metabolism defects regardless of the gene (ie including patients with mutations on the LTC4-synthase enzyme too) ? One possible answer is that it is established that patients with 5-lipoxygenase mutations are poor Singulair responders, so this trial might be designed to see if fish oils are of any use if Singulair fails ;- Dr. son's trial is due to be completed in July 2008, so we can reasonably expect a communication on the efficacy of anti-IgEs on AERD by next Fall or Winter ; theoretically, anti-IgEs should help alleviate AERD symptoms by calming parallel allergies, but it is doubtful they will be as efficient as leukotriene modifiers, because AERDs are not principally IgE-mediated ;- also, anti-IgEs may have side effects (see http://en.wikipedia.org/wiki/Omalizumab).Apart from these trials, a few others plan to test various combinations of existing antibiotics, with no real breakthrough likely.------------Montelukast + fish oilhttp://clinicaltrials.gov/ct2/show/NCT00676468?term=NCT00676468 & rank=1 Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthmaby : Indiana UniversityThis study is not yet open for participant recruitment. Description : combining fish oil supplementation and Montelukast [a commonly used cyst LT1 receptor antagonist to treat exercise-induced bronchoconstriction (EIB)] will provide a greater antiinflammatory effect against developing EIB that either agent alone 1 x 10 mg Montelukast tablet per day and 10 tablets of active fish oil (3.2 g EPA + 2.0 g DHA) for a duration of 3 weeks.Fish oil alonehttp://clinicaltrials.gov/ct2/show/NCT00621829?term=NCT00621829 & rank=1 Fish Oil to Prevent Asthma Exacerbations in Patients With ALOX5 PolymorphismsThis study is currently recruiting participants. by University of California, , April 2008Dietary Supplement: EPA enriched fish oilsSubjects will take the (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA) supplements as a capsule (3-4 g of EPA/day) for 90 days, followed by an 8 week washout period, and then will take a Placebo capsule for 90 days.Detailed Description: This study is a single-center, investigator-initiated, randomized, double-blind, placebo-controlled, cross-over trial. A total of 30 subjects will be recruited from the U.C. Asthma Network (UCAN) clinics. Some of the research will be conducted at the USDA-WHNRC (Western Health Nutrition Research Center) here at U.C. .This clinical trial is designed to study the effects of supplemental intake of eicosapentanoic acid (EPA)-enriched omega-3 polyunsaturated fatty acids (n3-PUFA, fish oil) in a subset of moderate to severe asthmatics, who have a high susceptibility to increased leukotriene production due to a polymorphism in the promoter region of the arachidonate 5-lipoxygenase (ALOX5) gene.EPA competes with AA and can decrease leukotriene production; thus our central hypothesis is that EPA-enriched n3-PUFA supplements will decrease the production of inflammatory leukotrienes and decrease the number of acute exacerbations of asthma in patients with moderate to severe asthma and that these benefits will be greater in subjects with the "high susceptibility" ALOX5 promoter variants. Our specific aims are to: 1) Determine the prevalence of the "high-susceptibility" ALOX5 pathway gene polymorphisms in a diverse cohort of moderate to severe adult asthmatics, 2) Perform a 32 week (12 wk treatment A - 8 wk washout - 12 wk treatment , blinded, cross-over design clinical trial, during which we treat 15 "high susceptibility" and 15 "low susceptibility" ALOX5 gene polymorphism asthmatics with n-3 PUFA supplements and placebo, and 3) Determine the baseline level and treatment effect of n-3 PUFA supplements on leukotriene metabolite and inflammatory cytokine production in subjects with the 'high' and 'low' susceptibility genotypes. Patients will be recruited primarily from the UC Asthma Network (UCAN).Xolair (anti-IgE) before aspirin desensitizationhttp://clinicaltrials.gov/ct2/show/NCT00555971?term=NCT00555971 & rank=1 Therapeutic Utility of Xolair in Patients Undergoing Aspirin Desensitizationby : The Cleveland Clinic and GenentechPurpose : This is a 24 week double-blind study consisting of up to 11 office visits for people 18 years of age with aspirin exacerbated respiratory disease (AERD). 21 subjects will participate and will be randomized 2:1 to receive Xolair (Omalizumab) or placebo. 14 subjects will receive Xolair and 7 will receive placebo. Xolair is a FDA approved medication for the treatment of moderate to severe allergic asthma. Injections will occur every 2-4 weeks, for 16 weeks. The dosage will be based upon IgE and body weight. Aspirin desensitization will occur 1-3 weeks later. One month after desensitization, the final visit will occur in the GCRC.Properly selected patients with aspirin exacerbated respiratory disease (AERD) experience benefit in the course of their disease with aspirin desensitization treatment; however, AERD patients are at risk for potentially serious asthmatic reaction when undergoing aspirin desensitization. For this reason, this procedure is currently performed in a monitored setting.We hypothesize that administration of Xolair, a monoclonal anti-IgE antibody, prior to the aspirin desensitization will reduce severity of aspirin-induced respiratory reaction, and that ultimately, use of Xolair will permit this procedure to be performed safely in outpatient settings. This protocol also entails obtaining blood and urine samples to assess the influence of Xolair, compared with placebo. As aspirin induced reaction occurs via heightened release of leukotrienes combined with greater end organ responsiveness to these mediators, we also will be quantifying the impact of prior administration of Xolair, compared with placebo, on the elevation of urinary LTE4 in association with aspirin challenge and with aspirin provoked reaction.Effect of Omalizumab (Xolair) in Treatment of Patients With AERD and Allergy Asthmahttp://clinicaltrials.gov/ct2/show/NCT00286416?term=NCT00286416 & rank=1 by : Srcipps Clinic (Dr. son)Study Start Date: January 2006Estimated Study Completion Date: July 2008Detailed Description: 60 patients with Aspirin Exacerbated respiratory Disease will be screened to determine if they also have allergic respiratory tract disease as a co-morbid complication. This will involve history, allergy skin tests and a serum IgE level. They must also have been desensitized to aspirin and be taking aspirin 325 or 650 mg morning and night.40/60 patients will receive omalizumab injections every month for the next 4 months and the other 20 patients, via a random program, will receive placebo injections.Monthly visits with the nurse co-ordinator will involve the following assessments: daily symptom scores, daily use of medications (particularly prednisone and rescue albuterol inhalers), lung function tests, nasal breathing test, measurement of smell and quality of life scores pre and post study.by Scripps Health, January 2006