A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced...
Exercise Induced BronchospasmThis 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.
Study to Assess Bronchospasm Potentially Induced by HFO vs HFA MDI in Participants With Well/Partially...
AsthmaA study to assess bronchospasm potentially induced by HFO MDI as compared with HFA MDI in participants with well controlled or partially controlled asthma
Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety...
AsthmaBronchospasm1 moreThe main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.
Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and...
Exercise-induced BronchospasmTo determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.
Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes...
BronchospasmExercise-InducedThis will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.
Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity
Asthma in ChildrenObesity2 moreGuidelines 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.
Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction...
AsthmaBronchospasmThis 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.
NIV Application in the Treatment of Asthmatic Children
AsthmaChild1 moreAsthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.
Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
AsthmaBronchospasm2 moreThis study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers. The current study is designed for a more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated, under augmented dose conditions.
Dose-Ranging Study of A006 DPI, in Adult Asthma Patients
AsthmaBronchospasmThis study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.