A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
AnaphylaxisHypotension2 moreBackground: Omalizumab is an approved drug for the treatment of asthma by the Food and Drug Administration. Researchers are now studying this drug in a double-blind placebo-controlled manner to assess efficacy in patients with idiopathic anaphylaxis (recurrent hypersensitive allergic episodes for which a cause is not identified). The study will improve understanding of the mechanisms involved in anaphylactic reactions as a response to the downregulation (a decrease in the number of receptors on the surface of cells) in mast cell (a resident cell with several types of tissues) activation, and lead to the development of strategies to better prevent or treat anaphylaxis. Objectives: To determine whether treatment with omalizumab will reduce or prevent episodes of unprovoked anaphylaxis (an acute allergic reaction) in subjects with a history of idiopathic anaphylaxis. To assess pharmacodynamics (physiological effects of a drug) and identify patients with undiagnosed mastocytosis (rare disorders caused by too many mast cells). To investigate cellular and molecular mechanisms of signaling and the effect of omalizumab on mast cells or basophils (a cell in the leukocyte family that releases histamine, which affects allergic response) and explore other regulatory pathways that may be involved with modulation of mast cell degranulation. Eligibility: Patients between 18 and 70 years of age who have been diagnosed with idiopathic anaphylaxis, a diagnosis that is made only after other causes of anaphylaxis have been considered. Patients with documented anaphylaxis episodes (mild to severe) at least six times within the past 1 year period, at least once within the last 4 months, and with at least one of the following: Elevated serum tryptase above baseline within 2 hours of the event. Emergency room visit with documented anaphylaxis without a known cause established by the acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (generalized hives, itching or flushing, swollen lips-tongue-throat) and at least one of the following: (1) respiratory compromise or gastrointestinal involvement (shortness of breath, wheeze-bronchospasm, throat tightness, low oxygen levels, nausea, vomiting, or abdominal pain); or (2) reduced blood pressure or associated symptoms of end-organ dysfunction (collapse, loss of consciousness, or loss of bladder or bowel control). Hospitalization for anaphylaxis. Patients must provide a letter of referral, with copies of pertinent medical history and laboratory tests, from the prospective participant s local physician, and have the ability to give informed consent. Women with childbearing potential must have a negative pregnancy test, and must agree to practice abstinence or effective birth control from the start of the protocol and for 3 months following the last injection of the study drug. Design: Participants will undergo a clinical evaluation, blood tests, and a bone marrow biopsy and aspirate. Participants will be randomized to either drug or placebo and will receive two doses of omalizumab or a matched placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months. Participants will remain on the assigned regimen for 6 months or until they have experienced new onset of severe adverse event on one occasion within 24 hours of study medication that are related to the study drug, whichever comes first. At that time, the participant will be discontinued from drug administration.
Combivent vs. Salbutamol in Patients With Metacholine Induced Bronchospasm
AsthmaThe purpose of this study was to evaluate whether 2 puffs of fixed combination of aerosolized 120 mcg salbutamol sulphate (equivalent to 100 mcg of the base) + 20 mcg ipratropium bromide confers significant additional protection against metacholine induced bronchoconstriction in asthmatic atopic patients when compared to 2 puffs of aerosolized 100 mcg salbutamol alone.
Pharmacokinetics of Nebulized Amikacin in Non Invasive Ventilated Healthy Volunteers.
Acute Respiratory InsufficiencyChronic Respiratory Insufficiency1 moreThe purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.
Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm...
AsthmaDelivery of HFA albuterol through an antistatic valved holding chamber (VHC) will improve bronchodilator response during nocturnal bronchospasm.
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By...
BronchospasmActivity/Exercise Induced BronchospasmDuring this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By...
BronchospasmActivity/Exercise Induced BronchospasmDuring this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)
AsthmaExercise-InducedThe purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.
Exercise Induced Bronchospasm in Children
Exercise Induced BronchospasmThe purpose of the study is to test how well 2 different medications stop asthma symptoms caused by exercising. The two medications that will be tested are "pretreatment with albuterol" and montelukast (Singulair®). Although both medications are used for treating asthma, we don't know which medicine is better at stopping asthma symptoms caused by exercising.
Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)
AsthmaExercise-InducedThe purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in participants who have a history of worsening asthma after exercise.
Efficacy of Nebulised Beclometasone in Viral Wheezing Prophylaxis
Bronchial SpasmRespiratory Sounds1 moreInhaled steroids, in particular beclomethasone, are widely prescribed in Italy as symptomatic treatment of upper respiratory infections without evidence of efficacy. The purpose of this study is to evaluate the efficacy of beclomethasone (administered by nebuliser twice a day) in preventing viral wheezing in pre-school children who had had episodes in the preceding 12 months.