27 Clinical Trials for Various Conditions
Exercise induced bronchospasm (EIB), also known as exercise induced asthma (EIA) is a transient obstruction to airflow triggered by exertion. It is now a well known identity, center of discussion in recent years, particularly in the athletes' world. It is more common in asthmatic individuals (regardless of severity of disease), but it is also seen in otherwise healthy subjects, leading to the general consensus that the pathophysiology is different than asthma. The concentration of exhaled nitric oxide (FeNO) in various airway \& respiratory disorders, particularly asthma, has been deeply studied. Its use for noninvasive monitoring of asthma control (reflecting airway eosinophilic inflammation) is being closely examined and put into clinical practice. FeNO is significantly elevated in asthma. Elevated FeNO levels have also been noted in patients hospitalized with a COPD exacerbation, acidosis, rhinitis, bronchiectasis, active pulmonary sarcoidosis, active fibrosing alveolitis, and acute lung allograft rejection. Decreased FeNO levels have been seen in patients with primary ciliary dyskinesia, cystic fibrosis, PiZZ phenotype-related alpha-1 antitrypsin deficiency, and pulmonary hypertension Two studies have addressed the variations on FeNO after EIB and they had contradictory results. Scollo et al. found no change in FeNO in either healthy or asthmatic children after a 6-min of vigorous exertion in an exercise laboratory when they studied 24 asthmatic and 18 control children. Terada et al. reported, for 39 subjects, a decrease in FeNO in subjects with EIB and an increase in healthy controls. It is well accepted that the pathophysiology of exercise induced bronchospasm it is not similar to that of asthma. Certainly the inflammation in the airway does not appear to be eosinophilic. Understanding the disease mechanism is a key factor to adequately manage it. This will be a prospective study measuring online exhaled nitric oxide involving children 8 to 21 years old. The study group will include any children coming for a pulmonary exercise test in the exercise laboratory located in the Pediatric Pulmonary Division office. The study will be conducted from the fall of 2009 until the spring of 2011. The change in the FeNO measurement will be correlated with the change in % predicted FEV1. We will consider significant a decrease in FEV1 post exercise of 15% and/or decrease on FEF25-75 of 20% that will persist until 15 minutes after completing exercise. We will also record any symptoms reported by the subject during or after the test. An exercise test is a standard of care when suspecting exercise-induced asthma. The subjects and their parents coming for exercise test will be offered the opportunity to participate in the study. The subject will come for the exercise test and will perform spirometry and FeNO measurement prior to start the test. According to our exercise laboratory protocol 1 minute of warm up at a low speed, followed by 6 minutes of high speed (enough to increase heart rate to 90% predicted or more) and 3 minutes of cool down at a low speed will be performed. Then spirometry will be repeated at 3, 5, 10 and 15 minutes and FeNO measurement will be taken at 5, 10 and 15 minutes. We will analyze the data to find if there is any significant change in FeNO measurements after exercise.
The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma. The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.
The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.
This study is investigating how commonly exercise-induced asthma happens in athletes and the best way to diagnose exercise-induced asthma. Exercise-induced asthma describes narrowing of the airways in the lungs that occurs in certain people when they exercise. This can cause shortness of breath, cough, and fatigue during exercise and can impair athletic performance. Exercise-induced asthma can be difficult to diagnose. This is a research study, because the investigators are examining the best way to document a diagnosis of exercise-induced asthma. The investigators are also interested in examining why exercise-induced asthma may occur.
This study was designed to examine the effectiveness of two bronchodilator inhalers in patients who have exercise-induced asthma.
The purpose of this study is to determine whether it is effective in the treatment of exercise-induced asthma and investigate the safety of oglemilast.
Due to the lack of studies examining the impact of inspiratory muscle training (IMT) on the severity of exercise-induced bronchoconstriction (EIB) and exercise performance, the specific aim of this study is to assess the efficacy of flow-resistive IMT on EIB severity and symptoms, short-acting beta-2-agonist medication use, operating lung volumes, respiratory and limb locomotor muscle deoxygenation during constant-load cycling exercise, exertional dyspnea, and cycling time-trial performance.
This study is intended to determine the dose response and duration of action of GSK2190915 in mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.
The purpose of the study is to find out how well a long-acting beta agonist like salmeterol works in people with different forms of the same gene. Our hypothesis is that asthmatics with the Arg/Arg genotype will have loss of bronchoprotection against exercise-induced asthma with regular salmeterol treatment, as compared to asthmatics with the Gly/Gly genotype.
We hypothesize that exercise-induced bronchospasm (EIB) at the NCAA Division I collegiate level is over diagnosed, while poorly controlled asthma resulting in exercise-related symptoms in this same population may be under diagnosed, being erroneously attributed to EIB. This project will test individuals self-identified as having exercise induced bronchospasm or asthma, as well as gender-matched controls from the same sport, with eucapnic voluntary hyperventilation to assess for the presence of EIB or asthma. By making the correct diagnosis, improved health outcomes may be achieved and athletic performance may be enhanced.
This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. The investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. The investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.
The prevalence of asthma continues to increase. Despite the large number of available therapies, many patients continue to require emergency deparment (ED) visits and intensive therapy. However, ED visits continue to be a major contributor to the healthcare cost of asthma treatment. In the United States alone, asthma is the 11th most common reason for ED visits, with ED visits and hospitalizations accounting for almost 50% of the healthcare cost for asthma. Additionally, while only 20% of asthmatics have had ED visits or hospitalizations, these patients account for over 80% of the direct costs for asthma treatment. Current National Asthma Education and Prevention Program (NAEPP) guidelines regarding management of acute asthma exacerbations in the ED setting include: oxygenation for most patients, inhaled short-acting β2-agonists and systemic corticosteroids. Zileuton, a specific 5-lipoxygenase inhibitor, has been extensively studied in inflammatory diseases such as asthma, which involve leukotrienes as mediators of inflammation. Zileuton Immediate Release (IR) tablets (Zyflo®) were approved by the Food and Drug Administration (FDA) in December 1996 for the prevention and treatment of asthma in adults and children 12 years of age and older. The results of the 2 pivotal studies in asthmatics with zileuton IR tablets demonstrated that zileuton at a dose of 600 mg QID produced and maintained a lasting improvement of lung function. In addition to the lasting effect of zileuton, an acute bronchodilation (as early as 60 minutes) was observed after administration of the first 600 mg oral dose. This acute bronchodilator effect may benefit patients during an acute exacerbation of asthma when added to the usual care in the ED or clinic setting. Critical Therapeutics has developed an injectable formulation of zileuton that will be explored for use in acute asthma exacerbations. This initial study is intended to provide PK data, information on safety and tolerability and some indication of pharmacologic activity as evidenced by lung function changes. In an attempt to enhance the potential for observing effects on lung function, only those patients with a demonstrated ability to respond by an increase in FEV1 of at least 10% within 3 hours after oral zileuton dosing will be enrolled.
This is a multicenter, randomized, double-blind, double-dummy, crossover study with two 2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in up to eight study visits and have a follow up phone call approximately a week after the last clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM and continue over a period of approximately 24 hours. Subjects will be required to attend three clinic visits during this 24-hour period. An exercise challenge (using a treadmill) will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment dose in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7. Spirometry will be conducted at specified visits and prior to and after each exercise challenge. Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to four weeks with intranasal corticosteroids followed by a repeat screening visit to determine eligibility prior to entry into the study. Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately 7-days after completing Treatment Period 2. The total duration of study participation is approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis. The primary objective of the study is to evaluate the protective effect of fluticasone furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP) 250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult subjects aged 12 to 50 with persistent asthma. ELLIPTA, ACCUHALER, and DISKUS are registered trademarks of the GlaxoSmithKline group of companies.
The goal of the study is to investigate the efficacy of an evidence-based weight loss intervention, on a background of quality health care, on asthma control among obese adults. The intervention will employ a combination of recommended dietary and physical activity changes, and behavioral modification techniques.
Guidelines from the American Thoracic Society strongly recommend interval warm-up exercise before planned exercise to reduce exercise-induced bronchoconstriction severity. However, no empirical data on the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity are available in obese asthmatic children, where excess fat exerts such an unfavorable burden on the respiratory system, particularly during exercise. The objective of this study is to investigate the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity in obese and nonobese asthmatic children. Our approach will be to investigate exercise tolerance, respiratory function, and exercise-induced bronchoconstriction severity and the effects of (1) 8x30sec interval warm-up \& (2) pretreatment with a bronchodilator compared with a no-treatment control on exercise-induced bronchoconstriction severity in 8-12 yr, prepubescent, obese and nonobese asthmatic children. \[Aim\]: To investigate the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity. \[Hypothesis\]: Interval warm-up exercise will reduce exercise-induced bronchoconstriction severity after an exercise challenge test to a similar extent as bronchodilator and better than control.
The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to placebo, will significantly attenuate airway inflammation and hyperpnea-induced bronchoconstriction in asthmatic individuals.
Docosahexaenoic acid (DHA) is a component of fish oil that is known to support a healthy cardiovascular system, maintain brain function, reduce depression, and improve inflammatory diseases. The study hypothesis is that DHA supplementation will diminish exercise-induced bronchoconstriction and airway inflammation as compared to placebo.
Combining fish oil and vitamin C supplementation will provide a greater anti-inflammatory effect against developing exercise-induced bronchoconstriction (EIB) than either nutritional supplement alone.
This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period, crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test for up to 10 minutes so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated.
The term exercise-induced bronchospasm (EIB) describes acute, transient airway narrowing that occurs during, and most often after, exercise. Manifestations of EIB can range from mild impairment of performance to severe bronchospasm and respiratory failure. The pathogenesis of EIB remains controversial and the role of airway inflammation has not yet been definitively characterized. We plan on comparing markers of inflammation in asthmatic participants with and without EIB at baseline and after bronchoprovocation with eucapnic voluntary hyperventilation testing (EVH). We also will collect demographic information as well as information about asthma control and exercise habits.
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in adolescent and adult subjects with asthma
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
It is our primary hypothesis that pretreatment with arformoterol will provide superior protection against EIB in children with mild-moderate asthma compared to placebo added to the current asthma regimen. Our secondary hypothesis is that nebulized arformoterol has comparable protection against EIB compared to inhaled formoterol by dry powder inhaler.
This clinical study will evaluate and establish the protective effects of Amphastar's Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1) Proventil®-HFA (Reference drug and Active Control ), and (2) Placebo-HFA control (HFA propellant only). Safety of the test drug, Albuterol-HFA, will also be evaluated in comparison to the Active and Placebo Controls. Analyses will be performed to determine if the Armstrong's Albuterol-HFA has resulted in a significant bronchoprotective effect, with attenuated Max % Fall in FEV1, in comparison to the Placebo-HFA control.
The purpose of this study is to determine if treatment of exercise-induced Bronchospasm with montelukast will help college athletes train more effectively and thus become more competitive in a non ergogenic manner.
During 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.
During 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.